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Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
95 mg/kg bw/day
Study duration:
subchronic
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

In a reproduction/developmental toxicity screening test (OECD 421) the test item (94.4% purity) was administered orally to 10 male and female Sprague Dawley rats in 0.5% carboxy methylcellulose by gavage at dose levels of 0, 30, 95 and 200 mg/kg bw/day. Mortality was reported in the 200 mg/kg bw/day dose group during the first 2 days of dosing. The selected dosage of 200 mg/kg body weight/day was considered not suitable for the study and for this reason animals were sacrificed after 2 days of treatment. The former medium dose group of 95 mg/kg body weight/day was defined as high-dose group and a new medium-dose group of 50 mg/kg body weight/day (dose group 5, five animals/sex) was added to the study. Male and female animals were dosed once a day, 7 days a week, for a minimum of 2 consecutive weeks prior to pairing. Thereafter, male animals were dosed through the day before necropsy, for at least 28 consecutive days. Female animals were dosed thereafter during pairing, post coitum and post partum periods until day 3 post partum or the day before sacrifice.

No relevant differences were observed in clinical signs, body weight, body weight gain and food consumption in treated animals compared to the controls. The reproductive parameters in terms of mating performance, pre-coital interval and copulatory evidence, were similar between groups, except for a reduction in number of days with presence of oestrous cycle observed in females treated at 50 and 95mg/kg body weight/day with unclear relation to treatment. Litter data, implantation, pre- and post-implantation losses and sex ratios did not differ between groups. Necropsy findings in pups did not show any findings related to treatment. Histopathological examination did not reveal any treatment-related effect. Based on the results of the present study, the NOAEL was considered to be 95 mg/kg body weight/day for males, for females and offspring.


Short description of key information:
In a reproduction/developmental toxicity screening test (OECD 421) the test item (94.4% purity) was administered orally to 10 male and female Sprague Dawley rats in 0.5% carboxy methylcellulose by gavage at dose levels of 0, 30, 50, and 95 mg/kg bw/day. No treatment-related effects were noted. Based on the results, the NOAEL for maternal and reproductive/developmental toxicity is considered to be 95 mg/kg bw/day.

Justification for selection of Effect on fertility via oral route:
GLP guideline study according to OECD 421

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

No adverse effects related to reproduction/developmental toxicity was reported in a GLP guideline study according to OECD 421 in rats after treatment with the test item. Based on the available data, the target substance does not warrant classification for reproductive toxicity.

Additional information