Registration Dossier
Registration Dossier
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EC number: 215-836-3 | CAS number: 1424-00-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
No mutagenicity assays were conducted with ZK 9226.
The acetate ester of ZK 9226 (ZK 5894) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurim strains TA 98, TA 100, TA 102, TA 1535, TA1537 and E. coli strain WP2uvrA) when tested up the highest recommended dose level of 5.0 mg/plate in the absense or presense of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats). [Schering AG, Report No. A25157; 2006-01-16]
A mutagenic potential of ZK 9226 is therefore not expected based on negative results with other steroid hormones in mutagenicity assays.
Short description of key information:
No data with ZK 9226; results of studies with mesterolone acetate (ZK 5894):
Gene mutation (bacterial reverse mutation assay / Ames test, GLP, OECD TG471): negative with and without metabolic activation
[Schering AG, Report No. A25157; 2006-01-16]
Endpoint Conclusion:
Justification for classification or non-classification
Not classified accoding to german legislation (TRGS-905) for androgenic steroids. No mutagenicity expected.
Based on the results there is no classification according to required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
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