Registration Dossier
Registration Dossier
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EC number: 612-953-5 | CAS number: 6218-29-7
Endpoint summary
Administrative data
Description of key information
Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg
[Bayer HealthCare, Bayer Schering Pharma, Report No. A34031 -draft-, 2008-03-05]
Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg
[Schering AG, Report No. A34485, 2008-08-07]
Key value for chemical safety assessment
Additional information
The single oral administration of the test substance (ZK 47359) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality.
No compound-related clinical signs were observed in males, in females only very slight and transient signs of impaired general condition were observed on the day of administration. There were no macroscopic pathological signs. The acute oral toxicity of Hydroxyestradienon in rats is therefore above 2000 mg/kg body weight.
The single dermal administration of the test substance (ZK 47359) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. One female showed thinning fur on both hind limbs and the abdomen in the last week of the study. No compound-related findings were observed in the other animals with regard to local and clinical observation, determination of body weight and necropsy examination.
The acute dermal toxicity of Hydroxyestradienon in rats is therefore above 2000 mg/kg body weight.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.
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