Registration Dossier
Registration Dossier
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EC number: 435-860-1 | CAS number: 214417-91-1
Endpoint summary
Administrative data
Description of key information
A skin sensitisation study was performed according to OECD Guideline 406 and GLP principles.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
GPMT study:
In a guinea pig maximisation test, performed according to OECD 406, guinea pigs were intradermally injected with a 1% concentration and epidermally exposed to a 50% concentration. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle. At induction, skin reactions varying between grades 1 and 2 were observed in nine experimental animals in response to the 50% test substance concentration. No skin reactions were evident in the control animals. Eschar formation was seen in the majority of the treated skin sites among the experimental animals. The skin reactions observed in response to a 50% test substance concentration in nine (of the ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.
These results indicate a sensitisation rate of 90 per cent. Based on these results the substance is a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the substance is classified as skin sensitizer according to CLP Regulation (EC) No. 1272/2008 and should be labelled as: May cause an allergic skin reaction (H317).
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