Registration Dossier
Registration Dossier
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EC number: 205-812-0 | CAS number: 153-00-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
There are no teratogenicity studies with metenolone(ZK 5466), read-across to results of studies with ZK 5469 (metenolone acetate):
Oral (Rabbit-NZW, non-GLP, doses: 0/ 1/ 3/ 10 mg/kg, once daily, days 6 to 18 p.c.): no effect
[Schering AG, report no. 1112, 1973-10-18]
Read-across to results of studies with ZK 5782 (metenolone enanthate):
Subcutaneous (Rat, non-GLP, Doses: 0/ 3.4 mg/kg (Days 15, 20 p.c.) and 0.57 mg/kg (Days 6, 13, 20 p.p.)/ 3.4 mg/kg (Days 15, 18 p.c.) and 0.57 mg/kg (Days 1, 4, 8, 11, 15, 18 p.p.)): no effects
[Schering AG, 1967-04-12]
Intramuscular (Mouse, non-GLP, Doses: 0/ 1.7 mg/kg (Day 5 p.c.)/ 1.7 mg/kg (Days 5, 7, 9, 11, 13, 15 p.c.)): no effects
[Schering AG, 1967-01-17]
Additional information
There are no teratogenicity (segment II) studies with ZK 5466 (metenolone). Results of studies conducted with metenolone acetate (ZK 5469) and metenolone enanthate (ZK 5782) are regarded as representative as most likely ester cleavage occurs in vivo.
No signs of embryotoxicity were seen in rats and rabbits for either ZK 5469 or ZK 5782.
Justification for classification or non-classification
There are nonNo data on reproductive toxicity of ZK 5466 available. ZK 5469 (metenolone acetate) and ZK 5782 (metenolone enanthate) were not teratogenic in rabbits. As for other anabolic steroids, long-term intake of ZK 5466 at doses which are pharmacologically effective is expected to lead to symptoms of masculinisation, as well as cycle- and fertility disturbances in woman. In men an impairment of the body's natural hormone production and fertility disturbances (inhibition of spermatogenesis) are to be expected in the long term. Exposure during pregnancy can lead to symptoms of masculinisation of the genital organs of a female child during fetal development. Metenolone, taken by breast-feeding women, may be absorbed into the mother's milk and thus impair the development of the child.
Classified according to german legislation (TRGS-905) as Repr. (F) Cat. 1 and Repr. (E) Cat. 2 (EEC criteria).
Classified as Category 1A according to Regulation (EC) 1272/2008 (CLP) criteria.
According to the Directive 67/548/EEC metenolone is classified:
Category 1; R60 - May impair fertility.
Category 2; R61 - May cause harm to the unborn child.
R64 - May cause harm to breastfed babies
Additional information
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.
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