Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Both in vitro and in vivo mutagenicity tests are available for Direct Red 81 and similar substance.

Bacterial reverse mutation assay, Ames test, showed negative results both with and without metabolic activation.

The in vitro gene mutation test, mammalian cell gene mutation assay, did not show any mutagenic effect.

The results of the in vivo micronucleous assay is negative.

Based on these tests, Direct Red 81 could be considered as not mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification for mutagenicity is warranted under Regulation (CE) 1272/2008.