Registration Dossier

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

OECD 471, analogue substance, negative with and without S9

OECD 476, HPRT, negative for analogue substance 2 and analogue substance 3

Additional information

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.

OECD 471 performed on analogue substance 4 showed clear negative results for all tested strain with and without Rat liver S9 metabolic activation system. The in-vivo test micronucleus performed on the analogue substance shows clear negativity. Based on these considerations and the read across assessment, the target substance is not considered mutagenic.