Registration Dossier
Registration Dossier
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EC number: 208-307-3 | CAS number: 521-18-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
No mutagenicity assay was performed with ZK 5145 (androstonolone), results of one study with a different ester of androstonolone (androstonolone acetate, ZK 5180, CAS 1164-92-7) is reported.
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]
A mutagenic potential of ZK 5145 is not expected based on negative results with other steroid hormones in mutagenicity assays.
Short description of key information:
No data with ZK 5145; read across with results of study with androstonolone acetate (ZK 5180, CAS 1164-92-7):
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: No adverse effect observed (negative)
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.
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