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Effects on fertility

Description of key information

A NOAEL of 1000 mg/kg bw was observed in male and female Sprague-Dawley rats in a reproductive/developmental toxicity screening study according to OECD guideline 421 (Calvert Laboratories, Inc., 2010; Klimisch 1). Based on the available data and according to the CLP criteria, the test substance should not be classified as toxic to reproduction.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A Reproductive / Development Toxicity Screening Testing in Rats was performed according to OECD guideline 421 (Calvert Laboratories, Inc., 2011, Klimisch 1). In this GLP-compliant study, male and female Sprague-Dawley rats (10 animals/sex/dose) were exposed to 1000 mg/kg bw/day. Control animals received concurrent vehicle (water). The rats were exposed on a daily basis, starting two weeks prior to cohabitation until the day before the scheduled euthanazia (minimum of 4 weeks) for males and starting for a minimum of 15 days prior to cohabitation, during cohabitation and from presumed gestation days 0 through day 19 of gestation for females. One female animal was found dead on lactation day 2. All other females survived until scheduled sacrifice. No treatment-related effects were observed in clinical signs, mortality, body weight (gain), food consumption, gross pathology, organ weights or histopathology in the parental animals. There was no treatment-related effect on reproductive performance or in reproductive parameters like for instance number of gravid animals, corpora lutea per dam, total implantations, litter viability or fetal sex ratios. The incidence of neonates born alive/found dead, stillborn or missing between lactation days 0 -4 was comparable among study groups. No treatment-related malformations were observed for neonates. The body weight of neonates was statistically significantly increased with an unknown biological significance for this finding. A NOAEL of 1000 mg/kg bw/day was established.

Effects on developmental toxicity

Description of key information
A combined reproduction/developmental study was performed via the oral route in rats and no adverse effects were observed at 1000 mg/kg bw. Based on these results it can be concluded that this endpoint has been adequately tested.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
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 the available data and the criteria laid down in the CLP regulation, the test substance is considered not to be classified as reproductive toxicant.