Registration Dossier
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EC number: 215-836-3 | CAS number: 1424-00-6
Endpoint summary
Administrative data
Description of key information
Oral, 52 weeks (Rat-Sprague-Dawley, non-GLP, doses: 0/ 0.6/ 6.0/ 20.0 mg/kg, once daily): NOEL < 0.6 mg/kg
[Schering AG, report dated 1967-12-30]
Oral, 52 weeks (Dog-Beagle, non-GLP, doses: 0/ 0.6/ 3.6/ 10 mg/kg, once daily): NOEL < 0.6 mg/kg
[Schering AG, report dated 1967-11-30]
Key value for chemical safety assessment
Additional information
ZK 9226 is a steroid with an androgenic potential.
The once daily oral administration of ZK 9226 to male and female Wistar rats at doses of 0, 0.6, 6.0 and 20 mg/kg for 52 weeks was tolerated without clear signs of organ toxicity. Reduced body weight and food consumption were seen in males at >= 0.6 mg/kg whereas increased body weight and food consumption were seen in females at >= 0.6 mg/kg. These findings correspond to the expected homonal mode of action of ZK 9226 in rodents. Additional findings at the high dose were vacuolation of adrenal cortices, atrophy of ovaries and increased extramedullar hematopoiesis in spleen. The NOEL is below the lowest tested dose of 0.6 mg/kg body weight after repeated dosing over 52 weeks.[Schering AG, report dated 1967-12-30]
The once daily oral administration of ZK 9226 to male and female Beagle dogs at doses of 0, 0.6, 3.6 and 10 mg/kg for 52 weeks was tolerated without clear signs of organ toxicity. Noteworthy findings were effects on endocrine organs affected dose-dependently in both sexes (e.g. decreased weights of uterus (at 10 mg/kg), prostate (>= 0.6 mg/kg) and epidedymides, reduced testicular sperm count (at 10 mg/kg) and possibly lack of estral manifestation). Slight signs of liver toxicity were densification of cytoplasma and vacuolation of hepatocytes without corresponding finding in clinical pathology. The NOEL is below the lowest tested dose of 0.6 mg/kg body weight after repeated dosing over 52 weeks. [Schering AG, report dated 1967-11-30]
Justification for classification or non-classification
Based on the results there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
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