Registration Dossier
Registration Dossier
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EC number: 617-707-0 | CAS number: 85390-93-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
No genotoxicity studies are available for 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one (ZK 91535). However, there is a genotoxicity study for the stereoisomer 3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one (ZK 70458):
3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one (ZK 70458) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurim strains TA 1535, TA 100, TA 1537, TA 1538 and TA98) when tested up to the highest recommended dose level of 5 mg/plate in the absense or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats). No growth inhibition was seen in any tested strain. Precipitates in the agar could be at 5 mg/plate.
Short description of key information:
No genotoxicity studies are available for 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one. However, there is a genotoxicity study for the stereoisomer 3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one:
Gene mutation (bacterial reverse mutation assay / Ames test, GLP, OECD TG471): negative with and without metabolic activation
[Schering AG, Report No. X514 -draft-, 2000-12-05]
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one can be expected to lead to the same effects as the stereoisomer 3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one.
Based on the results there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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