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EC number: 297-025-4
CAS number: 93281-13-1
A Combined Repeated Dose Toxicity Study
with the Reproduction/Developmental Toxicity Screening Test was
conducted to obtain information on the toxic potential of test item,
following the testing method and testing procedures outlined into the
OECD guideline 422.
The substance was administered to rats
orally (by gavage) once daily at 0 (vehicle only), 40, 120 and 350 mg/kg
bw/day doses. The concentration of the test item in the dosing
formulations was checked two times during the study and the
concentrations varied within the range of 97 and 103 % in comparison to
the nominal values.
All animals of the parent (P) generation
were dosed prior to mating (14 days) and throughout mating. In addition,
males received the test item or vehicle after mating up to the day
before the necropsy (altogether for 42 days). Females were additionally
exposed through the gestation period and up to lactation days 14-16,
i.e. up to the day before necropsy (altogether for 51-65 days).
There was no test item related mortality
at any dose level. A test item influence on the estrous cycle was not
found at any dose level and there were no toxicologically significant
differences between the control and test item treated male or female
animals in the examined parameters of reproductive performance or in the
delivery parameters of dams.
There were no test item related changes in
the serum thyroid hormone (T4 and TSH) levels at any dose (parental male
or 13-day offspring).
There were no toxic or other test item
related lesions detectable by histological examination in the
investigated reproductive organs (ovaries, uterus, vagina, testes,
epididymides, prostate and seminal vesicles with coagulating gland) of
male or female animals administered with 350 mg/kg bw/day.
No adverse effect on the mortality,
clinical signs, body weight development or necropsy findings were
detected in the offspring terminated as scheduled. The anogenital
distance (male and female) or nipple retention (male) were not affected.
Under the conditions of the study, the
substance did not adversely influence the reproductive performance in
parental male and female rats.
NOAEL (P0) (rat, male and female): 350
mg/kg bw/day, reproductive toxicity
NOAEL (F1): 350 mg/kg bw/day
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