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Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

there are no tumorigenicity studies with ZK 5686 available. No tumorigenic potential of ZK 5686 is expected based on data from long term studies with ZK 5623 (gestonorone caproat) in rats and dogs. No mutagenic potential of ZK 5623 was detected in vitro (Ames test) and in vivo (dominant-lethal test in male mice and rats). However, it has to be taken into account that sex steroids in general can promote the growth of specific hormone depedent tissues and tumors.

Classified according to German legislation (TRGS-905) for gestagenic steroids as Carc. cat. 3 (EEC criteria).

Classified with Category 2 according to Regulation (EC) 1272/2008 (CLP).

Classified as Category 3 (Xn, R40) according to Directive 67/548/EEC.

Additional information