Registration Dossier
Registration Dossier
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EC number: 200-289-5 | CAS number: 56-81-5
Endpoint summary
Administrative data
Description of key information
not sensitising, OECD 429: S.I. of 1.1, 0.7 and 0.5 at 25%, 50% and 100% v/v
not sensitising based on human data
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on reliable animal studies and human data, glycerol is not a dermal sensitizer
There was a negative result obtained in a local lymph node assay (LLNA) with glycerol. Compared to dimethylformamide (stimulation index 1) used as vehicle, testing with 25%, 50% or 100% glycerol resulted in a stimulation index of 1.1; 0.7 and 0.5, respectively (Ryan et al. 2000).
In the available evaluation performed by an official body (OECD 2002) one additional animal study (Hine 1953) with a clear negative result and some human experience was evaluated and summarised.
Conclusion: Based on the available information, there is no human or animal data that indicates glycerol to be a skin sensitiser. Considering the extensive, widespread dermal exposure to glycerol in preparations repeatedly applied to the skin, the absence of case reports of humans showing skin reactions is consistent with glycerol having a very low skin sensitisation potential.
There was no new relevant information identified up to and including 2021 (most recent literature research).
Glycerol, CAS Number 56-81-5, OECD SIDS Initial Assessment Report For SIAM 14 Paris, France, 26-28 March 2002
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
Although no study has been conducted to determine whether glycerol is a respiratory sensitizer, there is no indication from a 13-week inhalation study that respiratory sensitization is a concern.
Justification for classification or non-classification
There is no justification for classification based on data from available studies.
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