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EC number: 219-702-5
CAS number: 2500-88-1
A total of four groups (G1, G3, G3 and G4) of pregnant Wistar rats were
used in the study out of which, Group 1 (G1) served as the vehicle
control. Group 2 (G2), Group 3 (G3) and Group 4 (G4) were administered
the test item at the dose levels of 100, 300 and 1000 mg/kg/day
respectively, through oral route, once daily, from gestation days (GD) 5
One dam (Animal No. T106/056) was found dead on GD 16. Gross
pathological evaluations revealed presence of test item formulation in
the lung. The cause of death was attributed to accidental wrong dosing.
All other dams survived the entire treatment period and were found to be
normal and were free from all visible clinical signs.
There were no effects on maternal body weight and feed consumption. All
dams belonging to the control and treated groups displayed normal body
weight gain throughout the study period. Adjusted maternal weight (after
exclusion of uterine weight) of treated dams derived on GD 20 was
comparable to control group animals.
There were no changes in T3, T4 and TSH values attributable to
treatment. Gross pathological observations of control and treated dams
did not reveal any abnormalities. The absolute weight of thyroid along
with parathyroid of treated animals were comparable to the control
animals. Thyroid/parathyroid belonging to all control and treated group
animals were found to be normal (within histological limits).
No abnormalities were observed in the evaluated maternal parameters
viz., mean gravid absolute and relative uterine weights, placental
weight, number of corpora lutea, implantations, resorptions and
implantation losses in treated (100, 300 and 1000 mg/kg/day) group as
compared to the control group.
There were no significant changes in the mean number of male and female
foetuses and total number of foetuses in the treated group (100, 300 and
1000 mg/kg/day) as compared to the control group. Foetus weight was
comparable between treatment and control groups. No malformations
related to treatment were detected during external examination of the
pups belonging to the control as well as treated groups.
No abnormalities attributable to treatment were detected in any of the
treated and control groups during visceral and head razor examinations.
Foetal skeletal examination did not reveal any treatment related
abnormalities in any of the treated or control groups.
Pregnant Wistar rats when treated with the test item at 100, 300 and
1000 mg/kg/day did not reveal any maternal and foetal toxicity. No
teratogenic effects attributable to treatment were observed.
Based on findings, the NOAEL of the test item for maternal and foetal
toxicity in pregnant Wistar rats is 1000 mg/kg under the tested
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