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EC number: 810-533-8
CAS number: 330459-31-9
study was conducted to assess the developmental toxicity potential of
the test substance according to OECD Guideline 414 and OPPTS Guideline
870.3700, in compliance with GLP. The test substance, in the vehicle
(0.5% carboxymethylcellulose in water), was administered at the dose
levels of 10, 50 and 200 mg/kg bw/day orally by gavage to three groups
of 25 bred female Crl: CD(SD) rats once daily from GD 6 through 19. All
animals were observed twice daily for mortality and moribundity, and
individual clinical observations were recorded from GD 0 through 20.
Animals were also observed for signs of toxicity approximately 1 h
following dose administration. Body weights and food consumption were
recorded on GD 0 and 6-20 (daily). On GD 20, a laparohysterectomy was
performed on each female, and the liver, kidneys and adrenal glands were
weighed. These tissues and any tissues with gross lesions were preserved
for possible future histopathologic examination. The uteri, placentae
and ovaries were examined, and the numbers of fetuses, early and late
resorptions, total implantations and corpora lutea were recorded.
Gravid uterine weights were recorded, and net body weights and net body
weight changes were calculated. The fetuses were weighed, sexed and
examined for external, visceral, skeletal malformations and
developmental variations. All females survived to the scheduled necropsy
on GD 20. Several females in the 200 mg/kg bw/day group were noted with
test substance-related hair loss around the rump, hindlimbs, dorsal
abdominal area, and/or ventral neck, thoracic, and/or abdominal areas
during GD 8 through 20. No other test substance-related clinical
findings were noted at any dose level. Test substance-related lower mean
body weight gain and/or mean body weight losses and reduced food
consumption were observed in a statistically significant and
dose-dependent manner in the 50 and 200 mg/kg bw/day groups as early as
GD 6-9 and when the overall treatment period (GD 6-20) was evaluated.
The effects on mean body weight gain resulted in lower mean body weights
in the 200 mg/kg bw/day group but were not of sufficient magnitude to
affect mean body weight at 50 mg/kg bw/day. Furthermore, mean net body
weight gains at 50 and 200 mg/kg bw/day and mean net body weight at 200
mg/kg bw/day were statistically significantly lower than the control
group. Food efficiency at 50 and 200 mg/kg bw/day was similar to the
control group for the overall treatment period. There were no test
substance-related effects on mean body weights, body weight gains, net
body weight gain, food consumption, or food efficiency in the 10 mg/kg
bw/day group, net body weight at 10 and 50 mg/kg bw/day, or mean gravid
uterine weights at any dose level. A lower mean adrenal gland weight was
noted for females in the 200 mg/kg bw/day group relative to the control
group. There were no organ weight effects noted at 10 or 50 mg/kg
bw/day. No test substance-related macroscopic findings were noted at any
dose level. There were no test substance-related effects on intrauterine
growth and survival and fetal morphology at dose levels of 10, 50 and
200 mg/kg bw/day. Based on clinical findings of hair loss and lower mean
adrenal gland weights at 200 mg/kg bw/day and mean body weight losses or
lower body weight gains with corresponding lower food consumption at 50
and 200 mg/kg bw/day, the LOAEL was considered to be 50 mg/kg bw/day. A
dose level of 10 mg/kg bw/day was considered to be the NOAEL for
maternal toxicity. In the absence of any evidence of developmental
toxicity, a dose level of 200 mg/kg bw/day (the highest dose level
tested) was considered to be the NOAEL for prenatal development when the
test substance was administered orally by gavage to pregnant Crl: CD(SD)
rats (Stump DG, 2012).
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