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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg
[Schering AG, Report No. X298 -draft-, 1998-09-09]
Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg
[Schering AG, Report No. X285 -draft-, 1998-08-21]

Key value for chemical safety assessment

Additional information

The single oral administration of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one (ZK 91535) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. On the first day after administration slight to moderate apathy was observed, from day 2 onwards all animals were without clinical signs. Autopsy revealed no compound-related findings.The acute oral toxicity of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one in rats is above 2000 mg/kg body weight.

The single dermal administration of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one (ZK 91535) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one in rats is therefore above 2000 mg/kg body weight.

ZK 91535 caused discoloration of the skin at the application site but this effect was reversible within 48 hours and most probably due to the intensive green color of the test compound. No local intolerance reactions at the application sites were observed.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.