Registration Dossier

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:

Skin sensitization

The skin sensitization test was performed on a similar substance 01 (read-across from supporting substance -structural analogue or surrogate, following the OECD 406 and the EU B.6.

Test substance concentrations were first selected for the main study basing on the results of a preliminary study.

In the main study, ten experimental animals were intradermally injected with a 0.2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil).

Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.

No skin reactions were evident after the challenge exposure in the experimental and control animals.

Red/brown staining was observed at the test substance treated skin sites, 24 and 48 hours after challenge.

There was no evidence that the similar substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.

Justification for classification or non-classification

Skin sensitisation

According to the CLP Regulation n. 1272/2008, a substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test (according to 3.4.2.2.4.1).

There was no evidence that the similar substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 per cent.

Based on these results, according to the paragraph 3.4. of the CLP Regulation n. 1272/2008, the similar substance 01 shall be non classified as a skin sensitizer. According to the read-across from supporting substance-structural analogue evaluation, also the substance is not classified for this endpoint.