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Administrative data

Key value for chemical safety assessment

Additional information

ZK 57564 did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA100, TA1538, TA1535, TA1537) when tested up to the highest recommended dose level of 5.0 mg/plate in the absense or presense of extrinsic metabolic activation (liver S9 mix form Aroclor 1254 -treated rats). [Schering AG, Report No. X513-Draft; 2000-12-05]

Short description of key information:
Gene mutation (bacterial reverse mutation assay / Ames test, OECD TG471, GLP, non-audited report): negative with and without metabolic activation
(Schering AG, Report No. X513-Draft; 2000-12-05)

Endpoint Conclusion:

Justification for classification or non-classification

Due to the negative result of respective genotoxicity study there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).