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EC number: 413-110-2
CAS number: 135861-56-2
study was designed to investigate the effects of the test material when
administered throughout the reproductive cycle of the rat to assess
prenatal and postnatal development, and complies with the OECD
Guidelines for Testing of Chemicals No 415 "One Generation Reproduction
Toxicity Study" (Adopted 26 May 1983).
The test material was
administered by gavage to three groups, each of twenty four male and
twenty-four female Wistar Han™: HsdRccHan™: WIST strain rats, at dose
levels of 100, 300 and 1000 mg/kg/day. A control group of twenty-four
males and twenty-four females was dosed with vehicle alone (Arachis
Clinical signs, bodyweight development,
dietary intake and water consumption were monitored during the study.
Oestrous cycle assessment was performed daily for three weeks prior to
After ten weeks of treatment for males and
two weeks of treatment for females, pairing of animals within each dose
group was undertaken on a one male: one female basis, to produce
litters. During the lactation phase, daily clinical observations were
performed on all surviving offspring, together with litter size. Litter
weights and individual offspring weights were also recorded on specific
days post partum. The ano-genital distance was recorded for all F1
generation offspring on Day 1 post partum.
All males were terminated following the
completion of a successful mating. All surviving females and unselected
offspring were terminated on Day 21 post partum. All animals were
subjected to a gross necropsy examination and histopathological
evaluation of selected tissues from high dose and control animals was
performed. Selected offspring from each litter (where applicable) were
evaluated for sexual maturation.
One male treated with 1000
mg/kg/day was killed in extremis on Day 71. One female treated with 100
mg/kg/day was killed in extremis on Day 43 (during expected time of
parturition). There were no further unscheduled deaths during the study.
Clinical Observations. No
clinically observable signs of toxicity were detected in terminal kill
No adverse effect on bodyweight
gain was detected for males throughout the treatment period or for
females throughout maturation, gestation or lactation.
No adverse effect on food
consumption was detected.
No intergroup differences were
Oestrous Cycle Assessment.
There were no adverse effects on
oestrous cycle assessments.
No adverse effects on mating
performance was observed for treated animals when compared to controls.
Fertility & Pregnancy.
There were no adverse effects of
treatment on fertility or pregnancy rates between treated and control
treatment-related effects were evident in the length of gestation for
treated females when compared to controls.
Litter Responses. There
was no adverse effect of treatment of the parent female on implantation
rate, in-utero survival, litter size on Day 1 and subsequent offspring
survival to weaning at dose levels of 100, 300 or 1000 mg/kg/day. Sex
ratio of the offspring was essentially similar in all groups throughout
lactation. There was no obvious adverse effect of treatment of the
parent female on litter weights or offspring weight on Day 1 or
subsequent bodyweight gain to weaning at 100, 300 or 1000 mg/kg/day.
Offspring Ano-genital Distances.
No adverse effect was detected on
ano-genital distance between treated and control groups.
No toxicologically significant
effects were detected in terminal kill animals.
Organ Weights. No
treatment-related effects were detected in the organ weights measured.
No toxicologically significant
effects were detected in the sperm parameters measured.
No treatment-related microscopic
abnormalities were detected.
The administration of 4MDBS by
oral gavage to rats for either a period of up to one hundred and thirty
three consecutive days for males or at least seventeen consecutive days
prior to mating and throughout the gestation and lactation phases of the
reproductive cycle for female rats, did not result in any
toxicologically significant reproductive effects at dose levels of 100,
300 or 1000 mg/kg/day. A ‘No Observed Adverse Effect Level’ (NOAEL) of
1000 mg/kg/day was established for reproductive toxicity including
fertility and mating in adults and for developmental toxicity in their
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