Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The analogue substance 1 was found to cause positive mutagenic effects in bacterial tests. However, the findings were not confirmed in mammalian cells in vivo studies on two different analogue substances, having in common the central part of the molecule based on diazotised aromatic amines.

Based on the read across considerations, basic Brown 1 acetate is not considered to have mutagenic potential


Justification for selection of genetic toxicity endpoint
The mutation tests in in vivo (in vivo Micronucleus and USD) is a model clearly closer to the human situation than the Ames Test in bacteria and are considered more relevant than the bacterial test system. The negative results of these tests are confirmed in two studies in vivo micronucleus on analogue substance 2 and UDS on analogue substance 1.

Short description of key information:
Two in vivo mammalian gene mutation tests gave no indication of mutagenic potential

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of in vitro and in vivo mutagenic tests, no classification for genotoxicity is warranted under Regulation 1272/2008