947 lines
No EOL
43 KiB
JSON
947 lines
No EOL
43 KiB
JSON
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|
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|
||
"InterspeciesAF": "",
|
||
"InterspeciesJustif": "",
|
||
"OthInterspeciesAF": "",
|
||
"OthInterspeciesJustif": "",
|
||
"IntraspeciesAF": "",
|
||
"IntraspeciesJustifAF": "",
|
||
"DatabaseQualityDatabaseQualityAF": "",
|
||
"DatabaseQualityJustif": "",
|
||
"OthUncertaintiesAF": "",
|
||
"UncertaintiesJustif": ""
|
||
},
|
||
{
|
||
"label": "Explanation for hazard conclusion"
|
||
}
|
||
]
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Local effects",
|
||
"subsections": [
|
||
{
|
||
"label": "Long term exposure",
|
||
"HazardAssessment": "no hazard identified",
|
||
"StDose": "",
|
||
"MostSensitiveEndpoint": "",
|
||
"subsections": [
|
||
{
|
||
"label": "DNEL related information",
|
||
"DerivationMethod": "",
|
||
"AssessmentFactor": "",
|
||
"DoseDescriptorStart": "",
|
||
"StDose": "",
|
||
"DoseResponseAF": "",
|
||
"DoseResponseJustif": "",
|
||
"DiffInDurationAF": "",
|
||
"DiffInDurationJustif": "",
|
||
"InterspeciesAF": "",
|
||
"InterspeciesJustif": "",
|
||
"OthInterspeciesAF": "",
|
||
"OthInterspeciesJustif": "",
|
||
"IntraspeciesAF": "",
|
||
"IntraspeciesJustif": "",
|
||
"DatabaseQualityAF": "",
|
||
"DatabaseJustif": "",
|
||
"OthUncertaintiesAF": "",
|
||
"OthUncertaintiesJustif": ""
|
||
},
|
||
{
|
||
"label": "Explanation for hazard conclusion"
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Acute/short term exposure",
|
||
"HazardAssessment": "no hazard identified",
|
||
"StDose": "",
|
||
"MostSensitiveEndpoint": "",
|
||
"subsections": [
|
||
{
|
||
"label": "DNEL related information",
|
||
"DerivationMethod": "",
|
||
"OverallAssessmentFactor": "",
|
||
"DoseDescriptorStart": "",
|
||
"StDose": "",
|
||
"DoseResponseAF": "",
|
||
"DoseResponseJustif": "",
|
||
"InterspeciesAF": "",
|
||
"InterspeciesJustif": "",
|
||
"OthInterspeciesAF": "",
|
||
"OthInterspeciesJustif": "",
|
||
"IntraspeciesAF": "",
|
||
"IntraspeciesJustifAF": "",
|
||
"DatabaseQualityDatabaseQualityAF": "",
|
||
"DatabaseQualityJustif": "",
|
||
"OthUncertaintiesAF": "",
|
||
"UncertaintiesJustif": ""
|
||
},
|
||
{
|
||
"label": "Explanation for hazard conclusion"
|
||
}
|
||
]
|
||
}
|
||
]
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "General Population - Hazard via oral route",
|
||
"subsections": [
|
||
{
|
||
"label": "Systemic effects",
|
||
"subsections": [
|
||
{
|
||
"label": "Long term exposure",
|
||
"HazardAssessment": "no hazard identified",
|
||
"StDose": "",
|
||
"MostSensitiveEndpoint": "",
|
||
"subsections": [
|
||
{
|
||
"label": "DNEL related information",
|
||
"DerivationMethod": "",
|
||
"AssessmentFactor": "",
|
||
"DoseDescriptorStartingPoint": "",
|
||
"StDose": "",
|
||
"DoseDescriptorStartRTR": "",
|
||
"StDoseRTR": "",
|
||
"JustificationRTR": "",
|
||
"DoseResponseAF": "",
|
||
"DoseResponseJustif": "",
|
||
"DiffInDurationAF": "",
|
||
"DiffInDurationJustif": "",
|
||
"InterspeciesAF": "",
|
||
"InterspeciesJustif": "",
|
||
"OthInterspeciesAF": "",
|
||
"OthInterspeciesJustif": "",
|
||
"IntraspeciesAF": "",
|
||
"IntraspeciesJustif": "",
|
||
"DatabaseQualityAF": "",
|
||
"DatabaseJustif": "",
|
||
"OthUncertaintiesAF": "",
|
||
"OthUncertaintiesJustif": ""
|
||
},
|
||
{
|
||
"label": "Explanation for hazard conclusion"
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Acute/short term exposure",
|
||
"HazardAssessment": "no hazard identified",
|
||
"StDose": "",
|
||
"MostSensitiveEndpoint": "",
|
||
"subsections": [
|
||
{
|
||
"label": "DNEL related information",
|
||
"DerivationMethod": "",
|
||
"OverallAssessmentFactor": "",
|
||
"Extrapolated": false,
|
||
"DoseDescriptorStartingPoint": "",
|
||
"StDose": "",
|
||
"DoseDescriptorStartRTR": "",
|
||
"StDoseRTR": "",
|
||
"DoseDescriptorJustificationRTR": "",
|
||
"DoseResponseAF": "",
|
||
"DoseResponseJustif": "",
|
||
"InterspeciesAF": "",
|
||
"InterspeciesJustif": "",
|
||
"OthInterspeciesAF": "",
|
||
"OthInterspeciesJustif": "",
|
||
"IntraspeciesAF": "",
|
||
"IntraspeciesJustifAF": "",
|
||
"DatabaseQualityDatabaseQualityAF": "",
|
||
"DatabaseQualityJustif": "",
|
||
"OthUncertaintiesAF": "",
|
||
"UncertaintiesJustif": ""
|
||
},
|
||
{
|
||
"label": "Explanation for hazard conclusion"
|
||
}
|
||
]
|
||
}
|
||
]
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "General Population - Hazard for the eyes",
|
||
"subsections": [
|
||
{
|
||
"label": "Local effects",
|
||
"Conclusion": "no hazard identified"
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Additional information - General Population",
|
||
"DiscussionGenPop": "All NOAEL values are above the limit dose given in the OECD Test Guidelines thus derivation of DNELs is not justified.The only effect below a limit dose was the metaplasia of the squamous epithelium of the larynx seen in rats at 662 mg/m3 which was only minimal to slight, and thus is not interpreted as adverse."
|
||
}
|
||
]
|
||
},
|
||
"acute_toxicity": {
|
||
"sections": [
|
||
{
|
||
"label": "Administrative data"
|
||
},
|
||
{
|
||
"label": "Description of key information",
|
||
"KeyInformation": "The acute oral LD50 was determined in three species, rat, mice and guinea pigs. In all three species the oral LD50 was >/= 11,500 mg/kg.The acute dermal toxicity of glycerin was examined in guinea pigs.The dermal LD50 was determined to be 45 ml/kg (56,750 mg/kg) in guinea pigs.In an inhalation study, rats were exposed to aerosol from test material at targeted concentrations of 1.0,2.0,or4.0mg glycerol/L for 6 hours. The 4 h inhalation LC50 was determined to be above 5.85 mg/L in rats."
|
||
},
|
||
{
|
||
"label": "Key value for assessment",
|
||
"subsections": [
|
||
{
|
||
"label": "Acute toxicity: via oral route",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EndpointConclusion": "no adverse effect observed",
|
||
"EffectLevelUnit": "LD50",
|
||
"EffectLevelValue": "11,500mg/kg bw"
|
||
},
|
||
{
|
||
"label": "Acute toxicity: via dermal route",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EndpointConclusion": "no adverse effect observed",
|
||
"EffectLevelUnit": "LD50",
|
||
"EffectLevelValue": "56,750mg/kg bw"
|
||
},
|
||
{
|
||
"label": "Acute toxicity: via inhalation route",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EndpointConclusion": "no adverse effect observed",
|
||
"EffectLevelUnit": "LC50",
|
||
"EffectLevelValue": ">5.85mg/L",
|
||
"PhysicalForm": "inhalation: aerosol"
|
||
},
|
||
{
|
||
"label": "Acute toxicity: other routes",
|
||
"LinkToRelevantStudyRecord": ""
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Justification for classification or non-classification",
|
||
"JustifClassif": "There is no justification for classification based on data from available studies.",
|
||
"JustifClassif_STOTSE": ""
|
||
},
|
||
{
|
||
"label": "Additional information",
|
||
"Discussion": "Glycerol is essentially non-toxic following acute administration.In the available evaluations performed by official bodies (MAK 2007, OECD 2002, EFSA 2017) a number of additional acute toxicity studies were evaluated and summarised.All considered glycerol to be of low acute toxicity to mammals. The range of acute oral LD50 values derived from studies in experimental animals is between >4,000 and < 38,000 mg/kg, with the majority of values being between 23,000 and 38,000 mg/kg. For acute dermal toxicity a single LD50 of >18,700 mg/kg for rabbits was summarised by the OECD. The low level of acute toxicity in rodents is further supported by the results of the Danish (Q)SAR Database (LD50 rat oral 7500 mg/kg, LD50 mouse oral 13,000 mg/kg). There was no new relevant information identified up to and including 2021 (most recent literature research).(Q)SAR predicted profile for glycerol CAS -Nr 56-81-5, Danish (Q)SAR Database, http://qsar.food.dtu.dk Date: 09-02-2021Glycerin [MAK Value Documentation in German language, 2007]Re-evaluation of glycerol (E 422) as a food additive, EFSA Journal 2017;15(3):4720Glycerol, CAS Number 56-81-5, OECD SIDS Initial Assessment Report For SIAM 14 Paris, France, 26-28 March 2002",
|
||
"subsections": [
|
||
{
|
||
"label": "Attached background material"
|
||
}
|
||
]
|
||
}
|
||
]
|
||
},
|
||
"repeated_dose_toxicity": {
|
||
"sections": [
|
||
{
|
||
"label": "Administrative data"
|
||
},
|
||
{
|
||
"label": "Description of key information",
|
||
"KeyInformation": "In the best available dietary study, groups of 22 rats (Long-Evans)/sex/treatment received 5, 10 and 20% glycerol (natural or synthetic) in their diet (males 2000, 4000 and 8000 mg/kg bw; females 2500, 5000 and 10000 mg/kg bw) for 2 years. Although the results were not described in detail, based on this limited dietary study it can be concluded that no adverse effects were observed at up to 10,000 mg/kg bw.The effect of glycerine following administration for 90 days in a subchronic toxicity study was examined. Rats fed 5 or 20% glycerine in the diet for 90 days gained weight at a faster rate than control animals. There were no adverse treatment related effects noted in male or female rats fed 5% glycerine in the diet. In the male rats which received 20 percent glycerine, there was an increase in the final liver/body weight ratio and upon microscopic examination generalized cloudy swelling and hypertrophy of the parenchymal cells was observed. The only effect in the female rats on this level was some generalized cloudy selling upon microscopic examination of the liver. A 5% glycerol in the diet corresponded to 4580 and 6450 mg/kg/day for male and female rats, respectively, after 4 weeks and a 20% glycerol in the diet corresponded to 18,750 and 25,800 mg/kg/day for male and female rats, respectively, after 4 weeks.A number of other studies have been incorporated in the dossier. These studies are considered less reliable indicators of the systemic effects of glycerol following repeated administration, mainly because of limited toxicity assessments and/or deficient experimental design. The effects they do report are consistent with those observed in the key studies and as such they may contribute to the overall assessment of toxicity of glycerol.The effects following repeated dermal application of glycerin was examined. There were no effects noted in rabbits dosed 8 hours/day, 5 days/week for 45 weeks with dose levels as high as 4.0 ml/kg. Using a density of 1.2611 g/cm3 at 20 °C, a dose of 4.0 ml/kg corresponds to 5040 mg/kg/day.The subchronic toxicity of glycerol was examined following aerosol exposure. The NOAEC for local and systemic toxicity was 622 mg/m3.Migrated Data from field(s) Field \"Quality of whole database\" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The available information meets the information requirements under REACH Field \"Quality of whole database\" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The available information meets the information requirements under REACH"
|
||
},
|
||
{
|
||
"label": "Key value for assessment",
|
||
"ToxicEffectType": "",
|
||
"EndpointConclusionSystemicEffectsOralRoute": "no adverse effect observed",
|
||
"EndpointConclusionSystemicEffectsDermal": "no adverse effect observed",
|
||
"EndpointConclusionSystemicEffectsInhalation": "",
|
||
"subsections": [
|
||
{
|
||
"label": "Short-term repeated dose toxicity – systemic effects",
|
||
"subsections": [
|
||
{
|
||
"label": "Oral route",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EffectLevelUnit": "",
|
||
"EffectLevelValue": "",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "",
|
||
"System": "",
|
||
"Organ": ""
|
||
},
|
||
{
|
||
"label": "Dermal",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EffectLevelUnit": "",
|
||
"EffectLevelValue": "",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "",
|
||
"System": "",
|
||
"Organ": ""
|
||
},
|
||
{
|
||
"label": "Inhalation",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EffectLevelUnit": "",
|
||
"EffectLevelValue": "",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "",
|
||
"System": "",
|
||
"Organ": ""
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Sub-chronic toxicity – systemic effects",
|
||
"subsections": [
|
||
{
|
||
"label": "Oral route",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EffectLevelUnit": "",
|
||
"EffectLevelValue": "",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "",
|
||
"System": "",
|
||
"Organ": ""
|
||
},
|
||
{
|
||
"label": "Dermal",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EffectLevelUnit": "NOAEL",
|
||
"EffectLevelValue": "5,040mg/kg bw/day",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "rabbit",
|
||
"System": "",
|
||
"Organ": ""
|
||
},
|
||
{
|
||
"label": "Inhalation",
|
||
"LinkToRelevantStudyRecord": "001 | Key | Experimental study",
|
||
"EffectLevelUnit": "NOAEC",
|
||
"EffectLevelValue": "622mg/m³",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "rat",
|
||
"System": "",
|
||
"Organ": ""
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Chronic toxicity – systemic effects",
|
||
"subsections": [
|
||
{
|
||
"label": "Oral route",
|
||
"LinkToRelevantStudyRecord": "002 | Key | Experimental study001 | Key | Experimental study",
|
||
"EffectLevelUnit": "NOAEL",
|
||
"EffectLevelValue": "10,000mg/kg bw/day",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "rat",
|
||
"System": "",
|
||
"Organ": ""
|
||
},
|
||
{
|
||
"label": "Dermal",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EffectLevelUnit": "",
|
||
"EffectLevelValue": "",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "",
|
||
"System": "",
|
||
"Organ": ""
|
||
},
|
||
{
|
||
"label": "Inhalation",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EffectLevelUnit": "",
|
||
"EffectLevelValue": "",
|
||
"ExperimentalExposureTimePerWeek": "",
|
||
"Species": "",
|
||
"System": "",
|
||
"Organ": ""
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Repeated dose toxicity – local effects",
|
||
"subsections": [
|
||
{
|
||
"label": "Dermal",
|
||
"LinkToRelevantStudyRecord": "",
|
||
"EndpointConclusion": "",
|
||
"EffectLevelUnit": "",
|
||
"EffectLevelValue": "",
|
||
"TestType": "",
|
||
"Species": ""
|
||
},
|
||
{
|
||
"label": "Inhalation",
|
||
"LinkToRelevantStudyRecord": "003 | Other | Other result type001 | Key | Experimental study",
|
||
"EndpointConclusion": "no adverse effect observed",
|
||
"EffectLevelUnit": "NOAEC",
|
||
"EffectLevelValue": "662mg/m³",
|
||
"TestType": "subchronic",
|
||
"Species": "rat"
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Repeated dose toxicity: other routes",
|
||
"LinkToRelevantStudyRecord": ""
|
||
}
|
||
]
|
||
},
|
||
{
|
||
"label": "Mode of Action Analysis / Human Relevance Framework",
|
||
"ModeOfActionAnalysis": ""
|
||
},
|
||
{
|
||
"label": "Justification for classification or non-classification (Specific target organ toxicity-repeated exposure (STOT RE))",
|
||
"JustifClassif": "There is no justification for classification based on data from available studies."
|
||
},
|
||
{
|
||
"label": "Additional information",
|
||
"Discussion": "Study via the dietary, dermal and respiratory route demonstrate the low level of concern about glycerol.In the available evaluations performed by official bodies (MAK 2007, OECD 2002, EFSA 2017) a number of additional repeated dose toxicity studies were evaluated and summarised.Repeated dose toxicity oralIn the OECD SIDS document the study reported by Hine et al. was identified as the most relevant key study. This study is included in the REACH dossier in detail as RSS.A number of other studies have been incorporated in a table in the OECD SIDS document. These studies are considered less reliable indicators of the systemic effects of glycerol following repeated administration, mainly because of limited toxicity assessments and/or deficient experimental design. The effects they do report are consistent with those observed in the key studies and as such they may contribute to the overall assessment of toxicity of glycerol.EFSA conclusion: Short-term or subchronic studies were not performed according to current test guidelines. In a subchronic toxicity study (in drinking water) in rats, the effects reported were observed with doses in the range of the LD50 for glycerol. The Panel considered that the local irritating effects of glycerol in the gastrointestinal tract reported in some gavage studies in rat (100% glycerol at 2,800 mg/kg bw per day, the lowest dose tested (Staples et al., 1967)), and dogs (100% glycerol at 5,600 mg/kg bw per day (Staples et al., 1967)) was likely due to the hygroscopic and osmotic effects of glycerol.From the available chronic toxicity and carcinogenicity studies, glycerol was not carcinogenic in mice and rats and did not show evidence of adverse effects in a 2-year chronic toxicity study. The Panel noted that no adverse effects were reported in rats receiving doses up to 10,000 mg/kg bw per day for 1 year, the highest dose tested. The Panel also noted that there was no increase in the tumours incidences in rats receiving doses up to 5,000 mg/kg bw per day for 2 years, the highest dose tested.The Panel considered that none of the animal studies available identified an adverse effect for glycerol.Repeated dose toxicity inhalationThe key studies identified and evaluated by the OECD are compiled as RSS in the dossier (Renne 1992). Based on an increased incidence of “minimal” to “mild” squamous metaplasia of the epiglottis, the NOAEC for local irritant effects to the upper respiratory tract was derived at 165 mg/m3 and 662 mg/m3 for systemic effects.The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re-evaluated glycerol [56-81-5]in 2016, considering the endpoints irritation of the respiratory tract.Based on the results of an expert workshop, the NOAEC value for local toxicity was re-evaluated. Because the metaplasia of the squamous epithelium of the larynx seen in rats at 662 mg/m3 with glycerol aerosol was only minimal to slight, is not interpreted as adverse (Kaufmann et al. 2009). Furthermore it has been taken into account, that the response does not increase with the exposure duration.The NOAEC in rats for local and systemic effects after 13-week exposure is 662 mg/m3.Glycerin [MAK Value Documentation in German language, 2007]The MAK Collection for Occupational Health and Safety 2017, Vol 2, No 2Re-evaluation of glycerol (E 422) as a food additive, EFSA Journal 2017;15(3):4720Glycerol, CAS Number 56-81-5, OECD SIDS Initial Assessment Report For SIAM 14 Paris, France, 26-28 March 2002Kaufmann W, Bader R, Ernst H, Harada T, Hardisty J, Kittel B, Kolling A, Pino M, Renne R, Rittinghausen S, Schulte A, Wöhrmann T, Rosenbruch M (2009) 1st International ESTP Expert Workshop: “Larynx squamous metaplasia”. A re-consideration of morphology and diagnostic approaches in rodent studies and its relevance for human risk assessment. Exp Toxicol Pathol 61: 591–603",
|
||
"subsections": [
|
||
{
|
||
"label": "Attached background material"
|
||
}
|
||
]
|
||
}
|
||
]
|
||
}
|
||
} |