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EC number: 701-079-0
CAS number: -
of test item-related gross lesions
Number of animals per group
Teeth: abnormal growth
Teeth: irregular color
related to test item treatment.
of test item-related microscopic lesions
Number of rats with an incisor tooth gross anomaly submitted at microscopic examination
Teeth: disorganization/atrophy; ameloblasts
Teeth: degeneration/necrosis; ameloblasts
Number of mesenteric lymph nodes at microscopic examination
Mesenteric lymph node; infiltrate; macrophages
related to test item treatment.
The objective of this study was to
evaluate the potential toxicity of the test item, ITC288, following
daily oral administration (gavage) to rats for 13 weeks during an OECD
408 compliant study.
Four groups of ten male and ten female
Sprague-Dawley rats were orally (gavage) administered the vehicle
(sodium phosphate buffer 0.5M pH7.2 in drinking water) or the test item,
ITC288 (batch No. B288P22E1) at dose-levels of 100, 300 and 1000
mg/kg/day (active ingredient), under the constant dosage volume of 5
mL/kg, daily for 13 weeks.
Evaluations of animals included a daily
observations, weekly detailed clinical observation, weekly body weight
and food consumption recording, ophthalmological examinations (pre-dose
and in Week 13), monitoring of estrous cycle (Weeks 12 and 13),
hematology and blood biochemistry (Week 13).
At necropsy, spermogram, organ weight,
macro- and microscopic examinations were performed.
At necropsy, test item-related lower mean
body weights were noted in males treated at 1000 mg/kg/day.
Macroscopic test item-related abnormal
growth or irregular color of lower incisor teeth was observed in some
males and females treated at 1000 mg/kg/day. These findings correlated
with adverse ameloblast disorganization and atrophy associated with
degeneration/necrosis of these cells. The adjacent enamel was altered.
In the mesenteric lymph nodes from males
and females treated at 300 or 1000 mg/kg/day, non adverse infiltrate of
macrophages was seen.
In conclusion, the administration of
ITC288 at 100, 300 and 1000 mg/kg/day (active ingredient) for 13 weeks
to male and female Sprague-Dawley rats was well tolerated and resulted
in no mortalities. Adverse changes were observed at 1000 mg/kg/day only
and consisted in decreased body weights and body weight gains associated
with reduced food consumption in males only. In both gender, there were
increased absolute number of white blood cells and neutrophils, and
gross and microscopic findings in teeth. As such, the Non Observable
Adverse Effect Level (NOAEL) was 300 mg/kg/day.
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