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EC number: 470-080-3
CAS number: -
In a reproduction/toxicity screening test,
was administered orally via gavage to groups of 10 male and 10 female
Wistar rats (F0 animals) at doses of 100, 300 and 1000 mg/kg body
weight/day (mg/kg bw/d) in order to detect possible effects of the test
substance on the integrity and performance of the reproductive system of
both sexes. Control animals were dosed daily with the vehicle. The
duration of treatment covered a two-weeks premating period and mating
period in both sexes, approximately one week post-mating in males and
the entire gestation period and 4 days of lactation in females.
F0 animals were mated 13 days after the
beginning of treatment to produce a litter (F1 generation pups). Mating
pairs were from the same test group. Mating was discontinued as soon as
sperm was detected in the vaginal smear. F0 animals were examined for
their reproductive performance including determination of the number of
implantation sites and the calculation of postimplantation loss for all
F0 females. Food consumption of the F0 parents was determined regularly
during premating and after the mating period and during the gestation
and lactation periods in dams. In general, body weights of F0 animals
were determined once a week; however, during gestation and lactation, F0
females were weighed on gestation days (GD) 0, 7, 14 and 20, on the
parturition day and postnatal day (PND) 4. Pups were sexed on PND 0 and
weighed one day after birth and on PND 4. Their viability was recorded
until PND 4 when all pups were sacrificed with CO2 and examined
macroscopically for external and visceral findings. All surviving F0
parental animals were sacrificed by decapitation under isoflurane
anesthesia and were assessed by gross pathology. Sex organ weights were
recorded and a histopathological examination was performed. A detailed
examination of sperm was performed.
No test substance-related, relevant findings
were observed in F0 parental animals and F1 pups at all doses applied.
Thus, under the conditions of this reproduction/developmental toxicity
screening test the NOAEL (no observed adverse effect level) for
reproductive performance and fertility was equal to the limit dose of
1000 mg/kg bw/d recommended in the respective guideline for the F0
parental rats. The NOAEL for general, systemic toxicity of the test
substance was also 1000 mg/kg bw/d for the F0 parental male and female
animals. Treatment with the test article did not lead to any
pathomorphological changes with respect to the tissue and organs
examined during necropsy, organ weight determination and light
microscopy. The NOAEL for developmental toxicity in the F1 progeny of
the test substance-treated groups was found to be 1000 mg/kg bw/d.
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