Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Not a dermal sensitizer

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A Magnusson-Kligman maximization test (OECD 406) was conducted with guinea pigs to determine the potential for the test substance to invoke dermal skin sensitisation reactions. At the 48 hour challenge reading the irritation score for the test group animals and test vehicle control/naive animals was 0 for 29 of 30 animals. One test group animal at the 65% dose had a reading of 0.5. A reading of 0.5 - very faint erythema is not considered a positive reaction. Based on the results of this study, the test substance is considered not to be a contact skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

There was no evidence of dermal sensitisation in guinea pigs. The substance does not need to be classified for skin sensitisation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.