Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

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 mesterolone (ZK 9226), an impairment of the fertility of men and women has to be expected after repeated uptake of ZK 5894 at doses above therapeutic levels based on experimental findings in animal studies with ZK 9226. No data are available on embryotoxicity. The uptake of mesterolone acetate in pregnant women may cause the androgenization of the female fetus. Precautionally, the transfer of mesterolone acetate 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 mesterolonacetat 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