Registration Dossier

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

Estren-Cyanhydrin-3-Neopentylketal (3,3-(2,2-Dimethyltrimethylenedioxy)-17 alpha-hydroxy-5(10)-estrene-17 beta-carbonitrile) shows structural similarities to the progestin Dienogest. According to expert opinion Estren-Cyanhydrin-3-Neopentylketal could be a weak progestin if under the influence of gastric acid a ketal cleavage occurs at C3. Therefore the following self classification as reproductive toxicant is recommended according to the German TRGS 905 [1] for weak progestins:

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)

In addition, Estren-Cyanhydrin-3-Neopentylketal should be classified with DSD: R64 (May cause harm to breast-fed babies) and GHS: H362 (May cause harm to breast-fed children).

 

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