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EC number: 201-622-7
CAS number: 85-68-7
In a reliable two-generation reproductive toxicity study, male and
female rats received Santicizer 160 in the diet at 0, 50, 250 or 750
mg/kg bw/day for 10 weeks prior to mating and during the 2-week mating
period. The males were then killed, while the females continued with the
same treatment throughout gestation, lactation and weaning, until
sacrifice on postnatal day (PND) 21. The F1 offspring (reduced to 10
pups/litter on PND 4) were reared by their dams to PND 21, at which
point at least one pup/sex/litter was randomly selected to produce the
second (F2) generation and continued under the same exposure regime as
Systemic toxicity was seen in all three generations at the top dose,
which also produced reproductive toxicity. In the F0 generation this was
limited to the females (with reductions in the relative weights of the
ovary and uterus), while in the F1 generation both males and females
showed a reduction in mating and fertility indices. In the F1 and F2
offspring, growth was impaired and sexual maturation delayed at 750
mg/kg bw/day, while anogenital distance (an indication of foetal
androgen action) was reduced in F1 and F2 male pups from 250 mg/kg
bw/day. The no-observed-adverse-effect level (NOAEL) for reproductive
and systemic toxicity was 250 mg/kg bw/day, while that for developmental
toxicity was 50 mg/kg bw/day (based on the reduced anogenital distance
in F1 and F2 male pups).
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