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Key value for chemical safety assessment

Additional information

The study substance was not mutagenic in a range of in vitro and in vivo genotoxicity assays. In a bacterial test, the study substance was not mutagenic in Salmonella strains tested in the presence or absence of metabolic activation. It was also non-cytogenic in an in vitro mammalian cell assay and when tested in an in vivo mouse bone marrow micronucleus assay. Finally, it was not mutagenic in the mouse lymphoma L5178Y/TK+/- cell line, in both the presence and absence of an S9 metabolic system.  All studies were conducted in a manner similar or equivalent to currently established OECD guidelines. All available data indicate the study substance is non-genotoxic.


Short description of key information:

In vitro gene mutation in bacteria, Negative (equivalent or similar to OECD TG 471)

In vitro, gene mutation mammalian-Negative (equivalent or similar to OECD TG 476)

Cytogenicity, 2 key studies-Negative in vitro (OECD 473), Negative in vivo (equivalent or similar to OECD 474)


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The negative results in in vitro and in vivo genotoxicity assays do not warrant classification of the study substance as a genotoxin or a clastogen under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. 

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