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EC number: 700-195-9
CAS number: 223398-24-1
study was performed to evaluate the possible prenatal developmental
toxicity of GRO 266 by oral gavage in pregnant Wistar rats. The
method followed was as per the guideline of OECD N° 414 (January 2001).
Pregnant Wistar rats were exposed during gestational days
(GD) 5 to 19, to GRO 266 dissolved in distilled water once daily, by
oral gavage at the dose levels of 200, 400 and 800 mg/kg body
weight/day, based on test results of a dose-range finder study. Pregnant
rats from the control group were administered distilled water only.
Maternal body weights, clinical symptoms and feed consumption were
recorded throughout the gestation period. The treated and control rats
were sacrificed on GD 20, the uteri were removed, weighed and examined
for the number of implantation, resorption and for live and dead foetus.
The ovaries were checked for corpora lutea. The foetus were weighed and
examined for external, visceral, head razor section and skeletal
was not observed upto the dose level of 800 mg/kg body weight/day dose
group. Pregnancy data remained comparable between rats from various
treated groups and concurrent control group. All
the rats were normal during the treatment period.
mean maternal body weights of pregnant rats were significantly reduced
on 20th day of gestation at the dose levels of 400 and 800 mg/kg body
weight/day. The percent body weight change data remained comparable
between the rats from various treated groups and control group. The feed
consumption of the E+ rats was significantly reduced in all test groups
during 5th and 8th day of gestation, just starting with the oral
application of the test substance. This temporary reduction of feed
consumption was compensated in low dosed animals after the 8th day of
gestation and in the mid and high dosed groups after the 14th day of
gestation to be equivalent to the control group at the end of the
treatment phase. Based on pathological examinations, the test substance
up to the highest tested dose of 800 mg/kg body weight/day was found to
be non-toxic in maternal rats.
treatment related effects were observed in the mean prenatal data upto
the dose level of 800 mg/kg body weight/day. Statistically significant
reduction was recorded in the mean male, female and total (male +
female) foetus weight at the dose level of 800 mg/kg body weight/day as
compared to the control group.
No significant difference in the incidences of
malformation or birth defects was recorded during external, visceral,
head razor and skeletal examination of foetus from the control and
various treated groups.
From the present
study, it is concluded that the "No Observed Adverse Effect Level
(NOAEL)" for maternal toxicity of GRO 266 is conservatively considered
to be 200 mg/kg body weight/day due to reduced absolute body weight in
the 400 and 800 mg/kg body weight/day dose groups. It should be
mentioned that body weight of treated animals was not different to the
control group, when corrected by the individual uteri weights. The NOAEL
for fetal toxicity of GRO 266 is 400 mg/kg body weight/day due to
reduced body weight seen in 800 mg/kg body weight/day dose group.
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