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EC number: 248-580-6
CAS number: 27619-97-2
Analytical verification of dosing
The test substance was considered to be
homogeneously distributed in the diets and was considered to be stable
in the vehicle (tap water) when stored at 2-10°C for 10 days. The
concentration of the test substance was close to intended (85-115%) for
all diets at all dose levels, except for the lowest level measured on 9
March where a slightly higher deviation of 16.4% was found.
The study was
performed according to OECD TG 422 and GLP principles. The test
substance was administered once daily by oral gavage, as a suspension in
tap water. Controls were treated with vehicle (tap water) only. The
study comprised 4 groups of 12 male and 12 female Wistar Han IGS rats
(Crl:WI(Han)) each, viz. one control group that received the vehicle and
three groups that received the test substance. The dose levels have been
selected in consultation with the sponsor and are based on the results
of a 2-weeks dose-range finding study with the test item in rats. The
test substance was administered at dose levels of 5, 15 or 45 mg/kg body
weight/day during a premating period of 10 weeks and during mating (1
week), gestation and lactation until 14 days after delivery. Male
animals were sacrifices after 90 days of exposure. A dosing volume of 5
mL/kg body weight was applied in all groups.
parameters included clinical observations, body weight, food
and delivery parameters and individual pup parameters up to lactation
day 13. Atnecropsy animals were
macroscopically examined and several organs were examinedmicroscopically.
administration of test substance was well tolerated. There were no
in clinical signs, neurobehavioural observations, growth, food intake,
red blood cellvariables, clotting
potential and results on macroscopy.
evaluation revealed treatment related histopathological changes in the
by mild to moderate (multi)focal tubular dilatationin
1/12 high-dose females. Because of this finding, the kidneys of the low-
and mid-dose animals were also processed and examined microscopically.
There was no effect of the test substance on female fertility or
reproductive performance. There were no effects on the litter data in
the number of pups, pup survival, growth, sex ratio and developmental
Based on the
histopathological changes in the kidney in the females the NOAEL for
maternal toxicity was considered to be 15 mg/kg body weight per day.Based
on the absence of effects on fertility and developmental parameters, the
NOAL forfertility and developmental
toxicity was established at ≥ 45 mg/kg body weight per day.
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