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EC number: 629-732-4
CAS number: 1224966-13-5
The objective of this study was to
evaluate the potential of the test substance to produce developmental
toxicity when administered by a gavage to pregnant CD® rats during
organogenesis. Maternal toxicity was also evaluated. Timed-pregnant rats
were administered the test substance by gavage on gestation days (gd) 6
through 15. Twentyfive copulation plug-positive females per group were
dosed with undiluted test substance at dose levels corresponding to 100,
300 and 1000 mg active ingredient/kg/day. An additional 25 females,
assigned to the control group, received Milli-Q water at a dose volume
equivalent to that used in the high dose group. Clinical observations
were made daily (twice daily during dosing), and maternal body weights
were measured on gd 0, 6, 9, 12, 15, 18 and 21. At scheduled sacrifice
on gd 21, the dams were evaluated for liver and gravid uterine weights,
number of corpora lutea and number and status of implantation sites
(including early and late resorptions, dead fetuses and live fetuses).
Approximately one-half of the live fetuses in each litter were examined
for visceral and craniofacial malformations and variations. The
remaining one-half of the fetuses were stained with alizarin red S and
were examined for skeletal malformations and variations.
Maternal: The pregnancy rate was
equivalent across groups and ranged from 88 - 100%. No females aborted
or delivered early. At scheduled sacrifice, three females in the control
group, two females in the 100 mg/kg/day group and one female in the 300
mg/kg/day group were found to be nonpregnant. One female from the
control group and one female from the 300 mg/kg/day group contained no
viable fetuses at scheduled sacrifice. Twenty-one to 25 live litters
were available for evaluation from each group. One female in the 300
mg/kg/day treatment group became moribund and was sacrificed on gd 10.
Two to three dams in the 300 and 1000 mg/kg/day treatment groups
exhibited audible respiration during or subsequent to the treatment
period. None of these observations were considered to be test substance
related. There were no treatment-related effects on food consumption,
gestational body weight and body weight gain, corrected body weight,
corrected body weight gain, and gravid uterine weight. No
treatmentrelated differences in gestational parameters including total
number of implantations, number of viable implants, and number of
nonviable implants, were observed in any dose group.
Fetal: Fetal body weights per litter
were not affected by treatment.
No treatment-related malformations or
variations were observed in this study.
Maternal toxicity NOEL: > 1000
Developmental toxicity NOEL: > 1000
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