Registration Dossier

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Administrative data

Description of key information

Skin sensitisation

The test substance shows no skin sensitising potential in the Guinea Pig Maximization test.

Key value for chemical safety assessment

Skin sensitisation

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

Key study: Skin sensitisation_ 2009/1130545

The test substance was assessed for its skin sensitizing potential using the maximization assay in guinea pigs. Doses were based upon a preliminary irritation test and resulted in a 1% concentration for intradermal induction, and a 50% concentration for both topical induction and challenge.

At challenge, no skin reaction was noted in treated guinea pigs.

Based on this study, the test substance shows no skin sensitizing potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. In the challenge no skin sensitising effects were observed for the test substance. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918.