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EC number: 203-149-1
CAS number: 103-83-3
According to OECD TG 414 and under GLP conditions pregnant female rats
received orally 0, 35, 75 and 150 mg/kg bw/day by gavage on gestation
day 5 -19. All females were terminated on gestation day 20 and cesarian
section was performed to evaluate the developing organism.
At the highest dose of 150 mg/kg bw/day females gained markedly less
body weight (by 41 % compared to control) and a reduction (-13 %) in
overall food consumption. Fertility index and gestation index was
calculated to be 100 % in all treated animals including control animals.
Post mortem, no macroscopic abnormalities were observed. Thus, due to
the reduced weight gain at 150 mg/kg bw/day the NOAEL (maternal
toxicity) is considered 75 mg/kg bw/day.
No treatment related effects were detected in foetal viability (male and
female), or in foetal weights (male and females), or in growth and
development. Sex ratio was in the normal range. No treatment related
effects were detected on fetal external findings.
No treatment-related effects were detected on skeletal development
(including osseous and cartilaginous tissue) and none in the type and
incidence of skeletal or visceral findings in fetuses from females
treated with 150, 75 or 35 mg/kg bw/day.
A teratogenic effect of treatment was not evident up to and including
the highest dose level (150 mg/kg bw/day)
Thus, the NOEL (No Adverse Effect Level) for reproductive and
developmental toxicity isconsidered to be 150 mg/kg bw/day
In conclusion, despite general toxicity (body weight reduction) in
female rats at 150 mg/kg bw/day there is no evidence that the substance
shows developmental toxicity.
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