Registration Dossier

Diss Factsheets

Administrative data

Description of key information

skin sensitisation (m/f), 30% challenge, not sensitising

Key value for chemical safety assessment

Skin sensitisation

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

The analogue test item was tested for skin sensitisation following OECD 406 (Huntsman, 1993). The test item is a mixture of different substances that are closely related by a structural point of view. Under the experimental conditions the test item did not show any skin sensitizing potential.

Based on the read across considerations the same resutls can be applied to Acid Black 164.

Justification for classification or non-classification

Under Regulation 1272/2008 a substance is classified as skin sensitizer category 2 if, in a GPMT over the tested animals ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose.

The intradermal induction dose wa at 4% and the percentage responding is 10% at 48h, therefore the substance is not classified as skin sensitizer.