Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Ethisterone (ZK 4957) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 102, TA 98) when tested up to 2.5 mg/plate (precipitation found) in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rats) (Bayer Schering Pharma AG, Report No. A48453; 2010 -02 -02)

Short description of key information:
Gene mutation (Bacterial reverse muation assay/AMES test, GLP): negative with and without metabolic activation
[Bayer Schering Parma AG, Report No. A48453; 2010-02-02]

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Ethisterone (ZK 4957) was tested in a standard genotoxicity test and did not show any genotoxic potential. Thus, there is no sufficient evidence available to classify ethisterone as genotoxic.

Ethisterone is not classified as genotoxic according to the German legislation (TRGS-905).

Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.