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EC number: 214-881-6
CAS number: 1205-17-0
The repeated dose and
reproductive-developmental toxicity of the test material was assessed in
a screening study conducted in accordance with the standardised
guideline OECD 422 under GLP conditions.
The test material was dissolved in corn oil
and administered orally by gavage at 100, 300 or 750 mg/kg/day to
Sprague-Dawley strain SPF rats (12 males and 12 females for each group
in the mating group, and 10 females each in the control group and
750 mg/kg bw/day group as the non-mated group) for 14 days before mating
and throughout the mating period until the day before necropsy (42 days
in total) to males, for 14 days before mating and during the mating and
gestation periods until day 13 of lactation (51 to 63 days in total) to
females in the mating group and for 42 days to the females in the
non-mated group. In addition, for some animals in the 0 and 750 mg/kg
groups (5 males in the mated group and 5 females in the non-mated
group), a 14-day recovery period was provided after the 42-day
administration to examine the reversibility of the toxic changes. The
animals in the control group received the vehicle, corn oil, alone in
the same manner.
No deaths occurred in any dose group and
there were no changes suggestive of effects from administration of the
test material in the manipulative tests, grip strength, motor activity,
qualitative items in urinalysis, haematological examination, weight of
the thyroid gland, in the reproductive organ weights in males or at
necropsy. In the 750 mg/kg nw/day group, some clinical signs were
observed as were effects on food consumption, body weight gain,
urinalysis and clinical chemistry.
Males and females in the 750 mg/kg bw/day
group showed eosinophilic granular changes in the liver, and the females
in the mating group in the 300 and 750 mg/kg bw/day groups showed
involution of the acinus in the mammary glands (inguinal region), the
remaining corpus luteum graviditatis in the ovaries, and atrophy of the
thymus was observed in females in the 750 mg/kg bw/day mating
group. Males in the 300 mg/kg bw/day group showed a high value in
albumin. Among the above changes, the changes in the mammary glands
(inguinal region), ovaries and thymus were observed only in females in
the mating group and since the animals in the recovery group were not
subjected to mating, the reversibility was unclear. The other changes
were no longer observed or decreased, showing reversibility.
In the 750 mg/kg bw/day group, the following
changes were observed: a tendency toward a decrease in the oestrous
count and a tendency toward elongation in the mean sex cycle (oestrous
cycle), an increase in the percentage of females showing abnormalities
in the sex cycle, an increase in the percentage of deaths after
implantation, decreases in the number and percentage of live-born pups
and the viability index on day 4 after birth, low body weight of male
and female pups at the time of birth and suppressed body weight gain
thereafter. In the 300 mg/kg bw/day group, a decrease in the viability
index on day 4 after birth and suppressed body weight gain of male and
female pups were observed. There were no changes suggestive of effects
from administration of the test material in the number of days until
copulation, copulation index, insemination index, or fertility index or
in the histopathological examination of reproductive glands and
accessory sex organs of males. There were no changes suggestive of
effects from administration of the test material in the length of the
gestation period, gestation index, number of implantation sites,
delivery index, AGD or sex ratio and there were no abnormalities in the
lactation condition. There were no effects from administration of the
test material in the viability index on day 13 after birth, number of
mammary papilla or areola papillaris, or the weight of the thyroid gland
and there were no abnormalities in the external appearance of live-born
pups or the pups that died.
Under the conditions of this study, it
was judged that the NOAEL for the repeated dose toxicity of the test
material was 100 mg/kg bw/day for males and females. It was judged that
the NOAEL for the reproductive toxicity of the test material was 750
mg/kg bw/day for parent males and 100 mg/kg bw/day for parent females
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