Registration Dossier

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Administrative data

Key value for chemical safety assessment

Additional information

The analogue substance was tested for gene mutation following OECD 471 (NONS dossier, 1999). Different strains at concentrations ranging from 33 to 5000 ug/plate were tested with and without S9 mix showing no potential for gene mutation.

Based on the read across considerations same results apply to Reactive Orange 12:2.


Justification for classification or non-classification

Classification for mutagenicity under Regulation 1272/2008 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.

Based on the results from genetic toxicity tests the substance is not classified as mutagen.