Registration Dossier
Registration Dossier
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EC number: 250-882-8 | CAS number: 31981-44-9
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There are no tumorigenicity studies of gestonorone acetate (ZK 5624) available. No tumorigenic potential of ZK 5624 is expected based on data from long term studies with ZK 5623 (gestonorone caproate) in rats and dogs. No mutagenic potential of ZK 5623 was detected in vitro (Ames test) and in vivo (dominant-lethal test in mice). 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 Category 2 according to Regulation (EC) 1272/2008 (CLP).
Additional information
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