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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 (12
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 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. No deaths or moribund animals occurred in
any group throughout the study. Three females were subjected to
unscheduled sacrifice on GD 27 because of non-parturition. There were no
test item-related changes in the macroscopic and microscopic of
unscheduled sacrificed animals. No test item-related change was observed
in food consumption, functional behavior examination, motor activity
examination, macroscopic and microscopic findings. A significant
decrease in body weight gain (76% and 69% of control, respectively) was
observed in males and females at 800 mg/kg during the treatment days 1
to 50. Changes in hematology, clinical chemistry and organ weights were
not considered adverse since they were not correlated with microscopic
findings and reversed after recovery period.
the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity was
considered to be 200 mg/kg/day.
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