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Key value for chemical safety assessment

Effects on fertility

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
Additional information

The reproductive / developmental toxicity upon repeated oral exposure was examined in a GLP-compliant study performed according to OECD guideline 421 (BASF SE 80R0861/11X403 (2013)). Groups of 11 male and 11 female Wistar rats received the test material by oral gavage (vehicle: water) at dose levels of 0, 100, 300 and 1000 mg/bw/day during a 14-day premating period and during mating (maximally 14 days), gestation and lactation until postnatal day 3. The total exposure duration was at least 4 weeks for male rats and about 7 weeks for female rats.Males were sacrificed after they had been treated for at least 28 days. Dams and pups were sacrificed on day 4 post partum. If birth did not occur on the expected date (day 21 post coitum), the dam was sacrificed on day 25 post coitum.The following endpoints were evaluated to assess general parental toxicity: clinical observations, body weight, food consumption and macroscopic examination. Endpoints to assess reproductive/developmental toxicity included parental fertility and reproductive performance (macroscopic examination, weight of testes and epididymides, histopathological examination of testes, epididymides and ovaries, numbers of corpora lutea and implantation sites, pre-coital time, female fertility index, female conception index, gestation index and length, post-implantation loss) and litter data (numbers and sex of pups, stillbirths, live birhts, postnatal mortality, viability index, gross anomalies, weight gain, macroscopic examination of pups at scheduled termination and pups that died during the study). The results showed no treatment-related changes in any of the parameters examined. Based on these results the NOAEL was 1000 mg/kg bw/day.


Short description of key information:
The NOAEL based on a reproduction and developmental toxicity screening study in rats exposed by oral gavage, conducted according to OECD TG 421, was determined to be 1000 mg/kg bw/day

Effects on developmental toxicity

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

Justification for classification or non-classification

Based on the results of the reproduction and developmental toxicity screening study in rats, the test substance does not need to be classified according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Additional information

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