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Key value for chemical safety assessment

Justification for classification or non-classification

There are no data on the reproduction toxicity of androstanolone acetate (ZK5180) available. As other anabolic steroids, androstanolone acetate has an androgenic activity and long-term uptake of pharmacological doses can result in masculisation, cyclus abnormalities, and impaiment of fertility in women. In men the endogenous hormon production may be impaired, together with disturbed fertility (reduced spermatogenesis). The exposure during pregnancy can result in masculinization of the sexual organs of female fetuses in the womb. When androstanolone acetate is taken up by the nursing mother, it may be absorbed with the mothermilk and the development during infancy may be impaired.

Classified according to German legislation (TRGS-905) as Repr. (F) Cat. 1 and Repr. (E) Cat. 2 (EEC criteria).

According to the Directive 67/548 EEC, androstanolone acetate 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.

Classified as Category 1B according to Regulation (EC) 1272/2008 (CLP).

Additional information