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EC number: 947-946-9
CAS number: -
purpose of this study was to determine the potential toxicity of the
test item when administered daily for at least 28 days via oral gavage
to male and female Sprague Dawley rats and to determine potential
reproductive and developmental toxicity.
six (48/sex) Sprague Dawley rats were randomly assigned to four groups
(12 animals/sex). Animals were administered control substance (peanut
oil) or the test item at 0, 100, 300, or 700 mg/kg once daily via oral
gavage for at least 28 days. Animals were subjected to a full gross
necropsy on Study Day (SD) 35 (F0 males), or Postnatal Day (PND) 13
(parturient F0 females and pups). Females that did not litter were
subjected to a full gross necropsy on SD 57.
evaluated during the study included mortality, physical examinations,
cageside observations, body weights, body weight changes, food
consumption, vaginal cytology, clinical pathology (clinical chemistry,
hematology, and coagulation), thyroid hormone (T4) analysis (males and
PND 13 pups only), gross pathology findings, absolute and relative organ
weights, and histopathology findings.
with the test item at doses ≥ 300 mg/kg had an effect on the liver.
Test-substance related hepatocellular hypertrophy correlated with
increased liver weight parameters and increases in hepatobiliary enzyme
(GGT and/or ALTi) activities. Thyroid follicular cell hypertrophy in
males at doses ≥ 100 mg/kg/day and females administered ≥ 300 mg/kg/day
was considered most likely secondary to changes in the liver.
Additionally, test substance-related changes in the nonglandular stomach
consisted of mucosal hyperplasia with erosion or ulceration was observed
in animals administered 700 mg/kg/day, mild mucosal hyperplasia in one
animal administered 300 mg/kg/day and minimal hyperkeratosis and minimal
neutrophilic inflammation in another animal administered 300 mg/kg/day.
These changes may have been a systemic effect of the test substance or
secondary to direct irritation of the mucosa.
was no effect on mortality, physical examinations, cageside
observations, body weights, food consumption, vaginal cytology, clinical
pathology (hematology, coagulation, and urinalysis), thyroid hormone
analysis (males and PND 13 pups), or gross pathology findings at all
dose levels evaluated.
was no reproductive toxicity observed at all dose levels, up to 700
mg/kg/day. In the males at doses up to 700 mg/kg/day, there were no
differences in reproductive organ weights or reproductive parameters
evaluated. In females at doses up to 700 mg/kg/day, there were no
differences in estrus cycles, pregnancy, or conception rates.
summary, the test substance the test item did induce repeat dose
toxicity, although reproductive toxicity was not affected in male and
female rats. The repeat dose no adverse effect level (NOAEL) was
considered to be 100 mg/kg/day due to adverse body weight changes, organ
weight changes and microscopic findings of hepatocellular hypertrophy.
The 700 mg/kg/day dose was the NOAEL for both the females and males for
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