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EC number: 253-138-0
CAS number: 36631-30-8
Post-natal development examinations did
not reveal any significant differences relative to controls for survival
of offspring, sex ratio, bodyweight or bodyweight gain, auditory startle
and pupil closure responses, age at vaginal opening or preputial
At necropsy, there were no effects
attributable to treatment in either females (6 weeks of age) or males
(15 weeks of age). Assessment included morphology of the male and female
reproductive tract organs, weight of the male reproductive organs or
microscopic pathology of the testis.
There was a slight but statistically
significant (P<0.05) increase in the number of male animals with
retained areolar regions on evaluation at post-natal Day 13 at 1050
mg/kg/day. Affected animals had only one or two more sites than those in
the control group. The areolae present at post-natal Day 13 were no
longer present on re-examination on post-natal Day 18. In
the absence of any other supporting data, this finding was regarded as
being of questionable toxicological significance.
There was a higher incidence of
displaced testes in foetuses from the group treated at 1050 mg/kg/day
when compared with controls. However, the incidence was within the range
of recent historical control data of the test facility for this
endpoint. No displaced testes were noted in any of the foetuses
undergoing less rigorous examination prior to preparation for skeletal
examination. There was no difference in the incidence of non-scrotal
testes between males of treatment and control groups at 15 weeks of age.
The incidence of renal cavitation was
higher controls in foetuses that were macroscopically assessed prior to
skeletal examination. Again, this finding was within the range of recent
historical control values, and was not found during examination of
foetuses by the more rigorous serial sectioning technique.
The incidence of effects in the testes and kidneys appear
to be related to the low incidence of these findings in the concurrent
control group compared to the range of historical control values. The
observed incidences of these findings in treated groups were within the
range of historical controls from recent studies at the test facility
and they were not supported by complimentary observations made in
foetuses or offspring. They were therefore considered not to be related
A developmental toxicity study in the rat, extended to permit an
assessment of post-natal development, found no treatment-related effects
indicative of maternal toxicity. No effects on offspring body weights or
litter viability were observed. No developmental (teratogenic) effects
were observed and there were no effects upon sexual maturation or
development of the reproductive tract in male or female offspring that
were attributed to treatment.
NOEL maternal toxicity: 1050 mg/kg/day
NOEL pre-natal developmental toxicity: 1050 mg/kg/day
NOEL post-natal evaluation of offspring: 500 mg/kg/day; LOAEL: 1050
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