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EC number: -
CAS number: 2156594-77-1
The effects of the test substance were investigated, after oral
administration in female Wistar Hannover rats during pregnancy and
embryo-foetal development, from gestation Day 6 through Day 19. Females
were mated with sexually mature males of the same strain and then
assigned to 4 groups of 25 females each. The test item was applied at
the following concentrations (CMC 0.5 % served as vehicle): test group 1
(control): 0 mg/kg bw/d, test group 2 (low dose): 50 mg/kg bw/d, test
group 3 (mid dose): 200 mg/kg bw/d, test group 4 (high dose): 800 mg/kg
Body weight, daily clinical signs and food consumption were recorded
during the in vivo phase. All surviving females were caesarean-sectioned
onDay 20 post coitum and subjected to post mortem examination. Blood
collection for clinical chemistry and hormone determination was
performed on Day 20 post coitum. Organ weigtht (brain, adrenals, kidney,
liver and thyroid) was performed in all females. The number of corpora
lutea, implantations, early and late intrauterine deaths, live and dead
foetuses, liver and uterusweights, foetalweight and sexwere recorded.
The anogenital distance (AGD) in all live foetuses was recorded. All
foetuses were examined for external abnormalities. Approximately one
half of the foetuses in each litter was examined for fixed-visceral and
No animal died during the study. Clinical signs (salivation) noted in
few high dose females were considered to be treatment related. A trend
of decrease in body weight and body weight gain was detected in the high
dose females, together with a slight statistically significant reduction
in food consumption when compared to controls, indicating a slight
maternal toxicity. No treatment-related effects concerning clinical
biochemistry investigations or thyroid hormone determination were noted.
There was no effect of on the absolute and relative (to brain) organ
weights in treated females when compared to controls.
No treatment related effects were seen in litter data and sex ratios. No
treatment related differences were noted in the anogenital distance in
both sexes. The incidences of foetuses or litters with external findings
did not indicate test item-related effect. No skeletal malformations
were noted in foetuses.
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