Registration Dossier
Registration Dossier
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EC number: 218-378-2 | CAS number: 2137-18-0
Carcinogenicity
Administrative data
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
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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