Registration Dossier
Registration Dossier
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EC number: 207-096-5 | CAS number: 434-03-7
Endpoint summary
Administrative data
Description of key information
Skin irritation (Rat, GLP): non-irritant
[Bayer Schering Pharma AG, Report No. A49584, 2010-06-17]
Eye irritation (Rabbit, GLP): non-irritant
[Bayer Schering Pharma AG, Report No. A49729, 2010-06-16]
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The single dermal administration of ethisterone (ZK4957) to male and female rats in the doses of 2000 mg/kg resulted in hair loss in 1/3 female rat. Ethisterone is not skin irritating. (Bayer Schering Pharma AG, Report No. A49584, 2010-06-17)
The single administration of ethisterone (ZK 4957) to the right eye of male and female rabbits results in slight irritation on administration day which decreased in severity from day 2 onwards and were fully reversible on day 3. Ethisterone is not an eye irritant. (Bayer Schering Pharma AG, Report No. A49729, 2010-06-16)
Justification for classification or non-classification
Ethisterone (ZK 4957) was tested in one skin and one eye irritation test and did not show significant irritation potential.
Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.
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