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EC number: 212-110-8
CAS number: 763-32-6
This study was designed to evaluate
the potential toxic effects of the test item Isoprenol (IPN) when
administered to rats for a minimum of 28 days and to evaluate the
potential of the test item to affect male and female reproductive
performance such as gonadal function, mating behavior, conception,
parturition, and early postnatal development.
In general, it can be concluded that the
test item does not affect the reproductive performance of males and
females at any dosage level.
slight non-significant prolongation of pre-coital interval was observed
in the 450 mg/kg bw/day dose group. The
increase of pre-coital interval was not statistically significant and is
assumed to be associated with a general toxic effect of the test item in
the high dose. There
were no test item-related effects on other parameters of F0 reproductive
performance, gestation length, parturition, or reproductive organs at
any dosage level. Also, there were no changes in a mean number of pups
born, live litter size, and postnatal survival. However, the body weight
of newborn females (and less in males) was reduced in the 450 mg/kg
bw/day dose group; and normalized anogenital distance was slightly
non-significantly decreased in females as well as males newborns. The
slight increase in the percentage of newborn males was noted in litters
in the 150 and 450 mg/kg bw/day dose groups. The
number of F1 males with retention of areolae on PND 13 was slightly
non-significantly increased compared to the control group and historical
control data. A
visual emaciation of the offspring was found only in one litter from the
450 mg(kg bw/day dose group, was temporary; however, it was considered
to be adverse and test item-related.
Therefore the NOAEL of 150 mg/kg bw/day was
set for F0 an F1 reproductive toxicity.
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