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EC number: 202-993-8
CAS number: 101-97-3
test item was administered by oral gavage to Sprague-Dawley rats ( at
least12 animals per sex per group) at dose levels of 0, 50, 200 and 800
mg/kg with a dose volume of 2 mL/kg in corn oil as vehicle. Males and
females were dosed for two weeks prior to mating and continued through
the day before sacrifice in males (at least 50 days), and continued
through the lactation day (LD) 13 in females. Additional animals in the
recovery group at 0 and 800 mg/kg (6 animals per sex per group) were
also administered but not mated, and then assigned to 2 weeks of
recovery period after the completion of administration.
deaths or moribund animals occurred in any group throughout the study.
One dead fetus was observed in the uterus o one female. It was
considered to have toxicological relevance since test item-related
systemic (decreased body weight gain) and reproduction/developmental
(increased perinatal death and decreased live litter size) adverse
effects were observed at 800 mg/kg bwduring the study.
test item-related change was observed in food consumption, functional
behavior examination, motor activity examination, macroscopic and
significant decrease in body weight gain was observed in males and
females at 800 mg/kg bw. Changes were noted in hematology, clinical
chemistry and organ weights, but these were not considered adverse since
they were not correlated with microscopic findings and reversed after
reproductive/developmental observations, at 800 mg/kg bw, a significant
increase in gestation period and perinatal death and decrease in live
litter size and viability index were observed. A significant decrease in
body weight of male and female pups was observed on PND 0 (down to 83%
of control) and 13 (90% of control).
conclusion, systemic adverse effects including decreased body weight
gain were observed at 800 mg/kg bw. Regarding reproduction/developmental
effects, decreases in regularity of estrus cycle, live litter size,
viability index and body weights in F1 pups were observed at 800 mg/kg.
Increases in gestation period and perinatal death were also observed at
800 mg/kg bw. Therefore, the No-Observed-Adverse-Effect Level (NOAEL)
for general toxicity and reproduction/developmental toxicity was
considered to be 200 mg/kg bw /day, respectively.
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