Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Not skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

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

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), skin sensitiser is a substance that will lead to an allergic response following skin contact.

In case of a guinea pig maximisation test, a response of at least 30 % of the animals, responding at > 1 % intradermal induction, is considered as positive. Under the experimental conditions employed, no animals of the test group showed skin reactions 24 and 48 hours upon challenge with test substance at 5 % concentration.

Moreover, in a LLNA, a stimulation index > or = 3 is considered as a positive response. Under experimental conditions adopted in a LLNA, all tested concentrations produced a stimulation index below 1.6.

Based on available experimental findings, no classification applied to the substance.