Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

All mutagenicity studies have been performed on a similar substance 2.

Therefore Acid Brown 348 can be considered as a non mutagen substance for read across with similar substance 2.

Read Across is described in detail in section 13.


Justification for selection of genetic toxicity endpoint
The assessment of the endpoint is performed with the integrated evaluation of results for in vitro mammalian cell gene mutation assay and in vitro Mammalian Chromosomal Aberration test

Short description of key information:
non mutagen

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification for mutagenicity is warranted for substances which cause concern for humans owing to the possibility that they may

induce heritable mutations in the germ cells of humans

The classification in Category 2 is based on:

— positive evidence obtained from experiments in mammals and/or in some cases

from in vitro experiments, obtained from:

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by

positive results from in vitro mutagenicity assays.

In vivo negative tests are confirming that no mutagenicity is warranted under EC1272/2008 for the substance Acid Brown 348