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EC number: 214-494-2
CAS number: 1135-66-6
The reproductive and developmental
toxicity study of test material was performed on male and femaleWistar
Han (TM): RCCHan(TM): WIST strain rats. The test material was dissolved
in Arachis oil BP and administered in dose concentration 0,
30,300,600mg/kg bw /day via oral gavage for up to eleven weeks
(including a two week pre-pairing phase, pairing, gestation and early
lactation for females).Each treatment group contain 10 male and 10
female rats while a control group of ten males and ten females was dosed
with vehicle alone (Arachis oil BP). Clinical signs, bodyweight change,
dietary intake and water consumption were monitored during the study.
Pairing of animals within each dose group was undertaken on a one male:
one female basis within each treatment group on Day 5 of the study, with
females subsequently being allowed to litter and rear their offspring to
Day 5 of lactation. An additional pairing for high dose females that
failed to achieve pregnancy was performed to fully assess mating
performance and fertility. During the lactation phase, daily clinical
observations were performed on all surviving offspring, together with
litter size and offspring weights and assessment of surface righting
reflex. Adult males were terminated on Day 52 of the study following the
completion of the second pairing at 600 mg/kg bw/day. Females and
offspring were terminated on day 5 post partum. Any female which did not
produce a pregnancy (unless allocated to a further mating phase) was
terminated on or after Day 25 post coitum. All animals were subjected to
a gross necropsy examination and histopathological evaluation of
reproductive tissues was performed. Additional male organ weight and
detailed histopathological examination of the testes were performed to
more fully assess male fertility.
There were no unscheduled deaths in
the study.Transient post-dosing salivation was observed from Day 7 at
600 mg/kg bw/day and Day 13 at 300 mg/kg bw/day. This sign was observed
regularly throughout the treatment period with all animals being
affected at both dosages, although the incidence of thisfinding was
greatest at the high dosage. Transient post dosing salivation was also
observed at 30 mg/kg bw/day for two females on Day 2 and one male on Day
50 of this study.At 600 mg/kg bw/day body weight gain of males was
statistically significantly lower than control during thefirst week of
treatment. Subsequent body weight gains were considered to reflect
normal biological variation, but overall gain at termination remained
lower than control.
Bodyweight gain of males at 30 and 300
mg/kg bw/day and for females at all dosages, throughout the pre-pairing,
gestation and lactation phases of the study, were considered to have
been unaffected by treatment. Food consumption for both sexes was
considered to have been unaffected by treatment throughout the study,
and including gestation and lactation phases for females, at 30, 300 and
600 mg/kg bw/day. Food efficiency: At 600 mg/kg bw/day food conversation
efficiency for males was lower than control during week 1; subsequent
food utilisation was similar to control. Food conversation efficiency of
males at 30 and 300 mg/kg bw/day and for females at all dosages,
throughout the pre-pairing, gestation and lactation phases of the study,
were considered to have been unaffected by the treatment. Male
reproductive organ weights were unaffected by treatment at 30, 300 and
600 mg/kg bw/day and did not indicate any effect on fertility.
Histopathological examinations did not indicate any effect of treatment
at 600 mg/kg bw/day and these examinations, including detailed
assessment of the spermatogenetic cycle for the testes did not indicate
any effect on male fertility. Pre-coital interval and mating evidence at
the times of conception did not indicate any adverse effect of treatment
on mating performance at 30, 300 and 600 mg/kg bw/day. Fertility: At 600
mg/kg bw/day, only seven females delivered a litter following the
initial pairing but subsequent re-mating and additional assessment of
male organ weight and detailed testicular histopathology did not
indicate any treatment related effect on fertility for either sex. There
was also no effect of treatment on fertility at 30 and 300 mg/kg bw/day.
Gestation length was considered to be unaffected by treatment at 30, 300
and 600 mg/kg bw/day. Litter responses: Offspring litter size, sex ratio
and viability: There was no effect of maternal treatment on corpora
lutea and implantations counts, pre- and postimplantation loss, number offspring
born, sex ratio or subsequent survival to Day 4 of age at 30, 300 and
600 mg/kg bw/day. Assessment of surface righting ability on Day 1;
offspring clinical signs and necropsyfindings and did not indicate any
effect of maternal treatment. Assessment of surface righting ability on
Day 1; offspring clinical signs and necropsyfindings and did not
indicate any effect of maternal treatment.Macroscopic necropsy findings
did not indicate any effect of treatment at 30, 300 and 600 mg/kgbw/day.
HenceNo Observed Adverse Effect Level (NOAEL) for reproductive toxicity
was considered to 600mg/kg/day,When male and femalerats were treated
with test material orally for 11weeks.
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