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EC number: -
CAS number: -
In the subchronic oral toxicity study in rats, no effects were observed
on reproductive organs and tissues. Estrous cycles were NOT AFFECTED
after 12 and 13 weeks of dosing up to and including the highest dose
level of 1000 mg/kg/day. At the end of this subchronic study also no
effects were observed on sperm parameters (sperm motility, testicular
spermatid numbers and sperm morphology).
Treatment of pregnant rats with WS400123 was well tolerated and there
were no test-item related deaths. Clinical condition, body weight
performance, gravid uterine weight, adjusted body weight gain and food
consumption were not adversely affected by WS400123 at any dose level
investigated. There were no macroscopic abnormalities detected at
There was no effect of maternal treatment with WS400123 on the mean
numbers of corpora lutea, implantations, resorptions, live young, pre-
and post- implantation losses, sex ratio or on placental, litter and
fetal weights at any dose level investigated.
Evaluation of the fetuses did not reveal any adverse major, minor,
skeletal or visceral abnormalities which were considered to be related
to maternal treatment with WS400123.
Based on the results of this embryo-fetal toxicity study, it was
concluded that the dose level of 1000 mg/kg/day represented the No
Observed Adverse Effect Level (NOAEL) for maternal toxicity and for
embryo-fetal survival, growth and development.
the OECD 422 Study, it was demonstrated that treatment with WS400123 at
doses up to and including 1000 mg/kg bw/day for 35 to 57 consecutive
days did not induce any adverse effects on reproductive and
developmental endpoints. After subchronic oral exposure of rats no
effects on estrous cycles and sperm parameters were observed up to and
including the highest dose level of 1000 mg/kg/day.
the developmental toxicity study in rats no effects were observed in
dams and embryos up
to and including the highest dose level of 1000 mg/kg/day.
on these results no classification for reproductive toxicIty is
warranted according to European classification rules [REGULATION (EC)
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