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EC number: 262-309-9
CAS number: 60580-61-2
A study was conducted to evaluate the
reproductive toxicity potential of test material in rats for two
Male and female rats were administered test
material at the doses of 7.50, 15.00 and 30.00 mg/kg/d over two
successive generations. Control group animals received deionised water.
Exposure of F0 and F1 parental rats to test material showed significant
reduction in fertility, viability (days 0 and 4), and the body weight of
F1 and F2 pups from the high-dose group but caused no effects on litter
size, weaning index, and sex ratio. Significant reduction in body
weights of F0 and F1 parental males and postpartum dam weights female
rats. Exposure of test material to Fo and F1 generation parental animals
resulted in non significant change in clinical pathology parameters
(except the ALK level). Reduction of brain, liver, kidney, spleen and
seminal vesicles weights of males and in the spleen and uterus of
females was observed in F0 and F1 rats. Gross lesions were observed in
gastro-intestinal (GI) tract, lymphoreticular/ hematopoietic and
reproductive tract in parental rats in both generations. Reduced body
fat was also recorded in F1 parental rats.
Under the test conditions, administration of
test material to adult male and female rats throughout maturation,
mating, gestation and early lactation resulted in significant effects on
adults and offspring at 30 and 15 mg/kg/d. Although effects were seen at
7.5 mg/kg/d, these were considered to be toxicologically non significant
and is therefore considered to be the "No Observed Adverse Effect Level"
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