Registration Dossier
Registration Dossier
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EC number: 215-836-3 | CAS number: 1424-00-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
There is no fertility studies of mesterolone available. Result of one fertility study is cited in RTECS database (Jan. 2010).
Effects on female rat fertility after four days subcutaneous administration of mesterolon prior to mating: Other measures of fertility; TDLo: 600 ug/kg (4D pre) [Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- v. 16, p. 455, 1966 (ARZNAD)]
Short description of key information:
There are no fertility studies of mesterolon available. Results of one fertility study is cited in RTECS database (Jan. 2010).
Subcutaneous (rat): TDLo: 600 ug/kg (4D pre)
(Arzneimittel-Forschung. Drug Research. (Editio Cantor Verlag, Postfach 1255, W-7960 Aulendorf, Fed. Rep. Ger.) V.1- 1951- v. 16, p. 455, 1966 (ARZNAD))
Justification for classification or non-classification
Although no indications of an inhibition of the gonadotropin secretion and spermatogenesis were found in long-term clinical experience with ZK 9226, an impairment of male and female fertility has to be expected after repeated uptake of ZK 9226 at doses above therapeutic levels based on experimental findings in animal studies. No data are available on embryotoxicity. The uptake of ZK 9226 in pregnant women may cause the androgenization of the female fetus. Precautionally, the transfer of mesteroloneacetate into mother's milk should be taken into account, which might cause impairment of the development of the infant.
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 mesterolone 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
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