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EC number: 237-928-2 | CAS number: 14075-53-7
In a GLP-compliant OECD Guideline 407 study, groups of 10 male and female Wistar rats were administered the test substance in aqueous solution by gavage at dose levels of 0, 20, 80 or 320 mg/kg bw/day for 28 days, 7 days per week. In addition 5 male and 5 female animals from the control and high dose group were placed in the recovery groups for a recovery period of 14 days. Animals were observed for clinical signs, body weight, food and water consumption. Hematological and clinical chemistry examinations were performed at the termination of the study and after the recovery period on all animals. Urinalysis was performed on all animals a few days before termination of the study. After 8 days, at the termination fo the study and after the recovery period, biochemical examination was performed on all animals, including examination of total thyroxine, triiodothyronine and thyroid-stimulation hormone levels. All animals were subjected to necropsy, including macroscopic examination of the skin, orifices, eyes, teeth, oral mucosa and internal organs. Animals of the control and high dose groups were subjected to histopathological examinations. No mortalities or clinical signs were observed in the study. There were no effects on food and water consumption, body weight and body weight gain. No macroscopically visible changes were seen, which were considered to be compound-related. Organ weights were unaffected by treatment. Histopathological examination did not reveal any compound-related effect. Hematological examinations revealed slight but statistically significant decreases in erythrocytes counts and hematocrit value in female animals of the intermediate and high dose group. Females of the high dose group also showed slightly decreased hemoglobin values. The MCV values were not affected. All findings on hematological parameters were completely reversible after a 14-day recovery period. No treatment-related changes were detected by examination of the thyroid hormone levels in all dose groups. Clinical chemistry examinations revealed no compound-related changes in any dose group. No treatment-related changes were detected by urinalysis. Based on the slight decrease in erythrocytes counts and hematocrit and hemoglobin values in intermediate and high-dose females, which were fully reversible after 14 days recovery period, the lowest dose level of 20 mg/kg bw/day is considered to be a NOEL for females. Based on the lack of adverse changes the highest dose level of 320 mg/kg bw/day is considered to be a NOAEL for males and females.
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