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EC number: 300-723-4
CAS number: 127823-21-6
Table 1 - Clinical signs
Number of examined animals
M: Males; F:
Table 2 - Mean body weight change /
Mean body weight (expressed in g)
Dose level (mg/kg/day)
. Day 1
% from controls
. Day 4
. Day 8
. Day 11
. Day 14
Body weight change
. Days 1 to 4
. Days 4 to 8
. Days 8 to 11
. Days 11 to 14
. Days 1 to 14
applicable; In bold: change related to the test item treatment
The objective of this preliminary
study was to evaluate the potential toxicity of the test item, following
daily oral administration (gavage) in rats for 2 weeks in order to
assist the selection of dose levels for a further study to be performed
in this species.
Three groups of five male and five
female Sprague-Dawley rats were dosed daily by the oral route (gavage),
with the test item, at dose levels of 100, 300 or 1000 mg/kg/day. One
control group of five males and five females received the vehicle only
(corn oil) under the same experimental conditions. A constant dosage
volume of 5 mL/kg/day was used.
The animals were checked daily for
mortality and clinical signs were recorded daily.
Body weight was recorded once in
pre-test, on the first day of treatment and then at least twice a week
until the end of the study.
Food consumption was recorded twice a
week during the treatment period.
On completion of the treatment period,
all animals were euthanized and a full macroscopic post-mortem examination
was performed. Designated organs were weighed and selected tissues were
preserved. Based on findings detected at macroscopic examination, a
microscopic examination was performed on the stomach for all study
No unscheduled death occurred during
Minimal to severe hypersalivation was
observed with a dose-related incidence at = 300 mg/kg/day. Severity
grade of hypersalivation was also dose-related. This clinical sign,
commonly observed when a test item is administered by gavage, was not
considered as adverse.
A moderately lower body weight gain
(-21.1% compared to controls) during the first week and a slightly lower
body weight (approximately -4.4% compared to controls) during the second
week were recorded in males at 1000 mg/kg/day. Only slight body weight
loss was recorded in females between Days 1 and 4.
Food consumption was slightly reduced
only in animals treated at 1000 mg/kg/day during the first week.
No test item-related organ weights
variations or gross findings were noted. Decision was made to process
the stomach in all study animals for microscopic examination as a black
discoloration was seen in the stomach from 1/5 males treated at 300
mg/kg/day, 1/5 females at 300 mg/kg/day and 1/5 females at
1000 mg/kg/day but no test item-related microscopic findings were
Daily administration of the test item by
oral gavage for 14 days in Sprague Dawley rats at 100, 300 or 1000
mg/kg/day was clinically well tolerated. The test item treatment only
induced non-adverse hypersalivation at = 300 mg/kg/day and non statistically
slight effects on food consumption and body weight at 1000 mg/kg/day in males
Consequently and under the experimental
conditions of the study, the No Observed Adverse Effect Level (NOAEL)
was established at 1000 mg/kg/day in absence of adverse effects.
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