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EC number: 290-998-6 | CAS number: 90295-08-2
The test substance was tested for reproduction and subacute toxicity using the OECD Test Guideline No. 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on 28th July 2015.
The test substance was administered to rats in the form of solution in water for injection. Oral application by stomach tube was performed daily. The study includes four main groups; each main group consisted of 12 males and 12 females. Main groups contained 3 treated groups (doses 125, 500, 1000 mg/kg of body weight /day) and one control group (vehicle only).
During the study clinical observation and health status controls were performed daily. The body weight and food consumption were measured weekly or in the specified time intervals. Detailed clinical observation was carried out weekly. The functional observation was performed at the end of application and observation period. Vaginal smears were prepared daily, 2 weeks before start of administration period (oestrous cycle monitoring), during the mating period (until the presence of spermatozoa) and at necropsy day. Reproduction parameters relevant to pups (number of pups, weight of litters, weight, sex and vitality of pups, measurement of anogenital distance, nipple retention) were also recorded.
The study was finished by urinalysis, haematological and biochemical analysis and gross necropsy of animals. In all males of main groups the sperm parameters, sperm motility and sperm morphology were examined. The selected organs from adult animals were removed for weighing and histopathological examination. The thyroid gland was taken out, weighed and histologically examined in selected pups.
The test substance treatment did not affect physical growth of parental animals (body weight, body weight increment, food consumption) in any phase of the study (before mating, during mating period, pregnancy and lactation period) and absolute and relative weight of reproductive organs was not affected by the test substance treatment at all dose levels 125, 500 and 1000 mg/kg/day. Numbers of corpora lutea, implantations and pups were not influenced by the test substance treatment at any dose level too. No adverse effect of the test substance treatment was observed during biochemical examination of parental males (concentration of thyroxine hormone) not even during pathological and histopathological examination of reproductive organs in treated parental animals. Also evaluation of body weight of pups, development of pups, concentration of thyroid hormone (T4) in pups and macroscopical examination of pups did not reveal any influence of the test substance treatment at any dose level.
Slightly increased percentage of affected sperms and increased presence of sperms with changed motility was recorded at the dose level 125 mg/kg/day but male ability to produce sperm that can fertilise eggs was not affected.
Results of sperm morphology in males of the dose level 500 mg/kg/day was similar in comparison with control group. Slightly increased presence of sperms with changed motility was recorded at this dose level but male ability to produce sperm that can fertilise eggs was not affected.
Slightly increased percentage of affected sperms and increased presence of sperms with changed motility was recorded at the dose level 1000 mg/kg/day but male ability to produce sperm that can fertilise eggs was not affected.
The NOAEL (No Observed Adverse Effect Level) for reproduction and development was established as 1000 mg/kg body weight/day. All changes observed in parental males and females and in their offspring at all dose levels were considered to be of no toxicological significance.
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