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Administrative data

Key value for chemical safety assessment

Additional information

ZK 5180 (androstonolone acetate) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA98, TA 100, TA 1538, TA 1535 and TA1537) up to the highest tested concentration of 2.5 mg/plate (at which precipitation of test compound and cytotoxicity were observed) in the absence or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats). [Schering AG, Report X233, 1997 -07 -18]

Short description of key information:
Gene mutation (bacterial reverse mutation assay / Ames test, GLP, non-audited report): negative with and without metablic activation
[Schering AG, Report X233, 1997-07-18]

Endpoint Conclusion:

Justification for classification or non-classification

Not classified according to Directive 67/548/EEC, Regulation 1272/2008/EC (CLP) and German legislation (TRGS-905) for gestagens. No mutagenicity expected.