Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Study duration:
subacute
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

In a repeated dose oral toxicity study in rats (Wistar, OECD TG 407), the substance was adimistered via gavage to 5 rats/sex/dose at 0, 10, 30, 90 mg/kg bw (male) or 0, 5, 15, 45 mg/kg bw (female) in corn oil for 4 weeks. No adverse effects on reproductive organs or tissue were observed at 45 mg/kg bw (females) and 90 mg/kg bw (males).

Effects on developmental toxicity

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
The registrant is willing to conduct the study. OECD 414 in the rat is commissioned. Attached you find further details and the signed contract with the laboratory.
Species:
rat
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 all available data a classification according to Regulation (EC) No 1272/2008, Annex I is not warranted.

Additional information