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EC number: 618-312-6 | CAS number: 898566-17-1
In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats at dose levels up to 1000 mg/kg bodyweight/day (OECD 422; Peter, 2017). The parental and reproduction NOAELs were established as at least 1000 mg/kg body weight/day. The substance is therefore not classified as a reproductive toxicant according to the CLP Regulation.
Toxicity to reproduction:
A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed in rats, in which male and female rats were exposed to 0 (vehicle), 100, 300, 1000 mg/kg bw/day via gavage (OECD 422; Peter B, 2017). The vehicle used was propylene glycol and the test solutions were prepared daily and administered within 6 hours after preparation. No treatment-related or toxicologically relevant changes were observed in clinical signs, mortality, body weight and weight gain, food consumption and compound intake, haematology, clinical biochemistry, behaviour (functional findings), organ weights and organ / body weight ratios, gross pathology and histopathology (non-neoplastic). A nonadverse, treatment-related increase in follicular cell hypertrophy in the thyroid of treated females was observed starting at 100 mg/kg/day. This was considered to be adaptive. Length and normality of the estrous cycle, mating and fertility indices, precoital time and number of implantation sites were not affected by treatment up to 1000 mg/kg/day. The mean number of implantation sites was statistically significantly higher compared to that in controls but this was attributed to a lower control group rather than a higher treated group. No toxicologically relevant effects on gestation index and duration, parturition, maternal care and early postnatal pup development were observed. The post-implantation survival index, live birth, viability and lactation indices, sex ratio, anogenital distance, areola/nipple retention, were unaffected by treatment. In the F1 generation, clinical signs, body weight, external macroscopy and serum concentration of the thyroid hormone T4 (PND 13-15) were unaffected by test item treatment.
No toxicologically relevant effects on reproductive parameters were noted up to 1000 mg/kg.
Based on the above mentioned considerations, no adverse parental and reproduction toxicity was observed up to 1000 mg/kg. The parental and reproduction NOAEL were established as being at least 1000 mg/kg bodyweight/day.
In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422; Peter B, 2017), the test item was administered daily to rats at dose levels up to 1000 mg/kg body weight/day. The developmental NOAEL was established as being at least 1000 mg/kg body weight/day. The substance is not classified as a reproductive toxicant according to the CLP Regulation.
Based on the results OECD 422 test, the following No Observed Adverse Effect Levels (NOAEL) were derived:
Parental NOAEL: at least 1000 mg/kg bw/day
Reproduction NOAEL: at least 1000 mg/kg bw/day
Developmental NOAEL: at least 1000mg/kg bw/day
Therefore, the substance is not classified as a reproductive toxicant according to the CLP Regulation.
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