Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 207-096-5 | CAS number: 434-03-7
Endpoint summary
Administrative data
Description of key information
Oral (Rat, GLP): LD50 > 2000 mg/kg
[Bayer Schering Pharma AG, Report No. A49530, 2010-06-08]
Dermal (Rat, GLP): LD50 > 2000 mg/kg
[Bayer Schering Pharma AG, Report No. A49584, 2010-06-17]
Key value for chemical safety assessment
Additional information
The single oral administration of ethisterone (ZK 5957) to male and female rats at a dose of 2000 mg/kg was tolerated without any compound-related clinical or macroscopical pathological signs. The acute oral toxicity of ethisterone in rats is > 2000 mg/kg body weight. (Bayer Schering Pharma AG, Report No. A49530, 2010-06-08 )
The single dermal administration of ethisterone to male and female rats in the doses of 2000 mg/kg resulted in hair loss in 1/3 female rat. No other compound-related clinical or macroscopic pathological signs were observed. LD50 > 2000 mg/kg (Bayer Schering Pharma AG, Report No. A49584, 2010-06-17)
Justification for classification or non-classification
Due to the results (LD50 > 2000 mg/kg) in the dermal and oral acute toxicity tests classification according to Directive 67/548/EEC and Regulation 1272/2008/EC is not required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
