Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on endocrine pharmacological studies in rats ZK 9227 (17ß-hydroxy-1¿-methylandrost-4-ene-3-one) is considered as a weak androgen. According to the German TRGS 905 [1] weak androgenic steroids have to be classified as reproductive toxicants as follows:

DSD: R62, Repr. Cat. 3 (Possible risk of impaired fertility) and R63, Repr. Cat. 3 (Possible risk of harm to the unborn child)

GHS: Repr. 2 (H361fd: Suspected of damaging fertility, suspected of damaging the unborn child)

 

[1] TRGS 905: Technische Regeln für Gefahrstoffe ¿ Verzeichnis krebserzeugender, erbgutverändernder oder fortpflanzungsgefährdender Stoffe. Ausschuss für Gefahrstoffe (AGS), edited July 2005, www.baua.de

Additional information