Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based on the data on the propylene glycol metabolite and the study of limited value on the test substance itself, it is expected that the substance is not sensitizing to the skin. There are no data on the diamine metabolite in the current dossier, but 2-methylpentane-1,5-diamine is not classified as skin sensitizer (nor is hexamethylenediamine).
Migrated from Short description of key information:
The substance (75%) and a positive control were applied 10 times to the skin of 10 guinea pigs/group. 17 days after the 20 day induction phase, a challenge with either the testsubstance (75%) and the positive control showed both minimal to slight local effects on the skin. The 75% concentration is considered not sufficient for the induction phase as the PIT showed that at 100% only minimal effects of irritation were apparent. In absence of a negative control group and the minimal difference in the results of the positive control and the test substance, no conclusion can be drawn from this study.
In a maximisation test in guinea pigs (n=20), the metabolite propylene glycol did not induce sensitization. Several other protocols were tested in comparison, all leading to the same result. Therefore propylene glycol is considered not sensitizing to the skin.
Justification for selection of skin sensitisation endpoint:
There are no indications that the substance is a skin sensitizer
Justification for classification or non-classification
Based on the results of tests with the substance and propylene glycol and the absence of classification for 2-methylpentane-1,5-diamine, it is concluded that the substance is not sensitizing
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