Registration Dossier

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

Additional information

No carcinogenicity studies are available for hydroxy-estrenon (ZK 5252). However, ZK 5252 has a structural similarity to nandrolone (ZK 5221). Only the position of one double bond differs between both substances. But the isomerisation of this double bond from 5,10 -position to 4,5 -position will easily occur in vivo. Therefore, a close effect relationship between ZK 5252 and ZK 5221 has to be assumed in vivo. These information were described in an internal communication by N. Schmees to A. Klaus (3. Jun 2016).

Justification for classification or non-classification

There are no studies to the carcinogenicity of hydroxy-estrenon (ZK 5252) available. However, ZK 5252 has a steroid-like structure.It has to be taken into account that steroids in general can promote the growth of specific hormone depedent tissues and tumors.

ZK 5252 has a structural similarity to nandrolone (ZK 5221) and will in vivo be transformed to ZK 5221, which is classified according to German legislation (TRGS-905) for anabolic steroids as carc. 2 and is classified with category 2 according to Regulation (EC) 1272/2008 (CLP).

Based on read across to nandrolone (ZK 5221), ZK 5252 is classified with category 2 according to Regulation (EC) 1272/2008 (CLP).