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EC number: 206-017-1 | CAS number: 288-13-1
4-Week rat drinking water study NOAEL: 20 ppm (1.5 and 1.9 mg/kg/day for males and females, respectively); LOAEL: 100 ppm (7.3 and 9.2 mg/kg/day for males and females, respectively); OECD 407; Reliability = 1
In conclusion, the following substance-related effects were seen:
600 ppm (38.9 mg/kg bw/day in males, 84.0 mg/kg bw/day in females)
- impairment of water consumption in males and females - impairment of food consumption in males and females
- impairment of body weight, resulting in reduced values of 16.9%/17.3% [males/females] on day 28
- impairment of food efficiency in males and females
- increases in platelets, total bilirubin, total protein, globulins, cholesterol and urinary specific gravity in both sexes
- dark yellow discoloration of the urine specimens in both sexes
- increases in albumin and urinary blood in the males - increases in white blood cells, lymphocytes, alanine aminotransferase, sodium, inorganic phosphate and thyroid stimulating hormone (TSH) in the females - decreases in hemoglobin, alkaline phosphatase, urea, triglycerides and urinary volume in both sexes - decreases in red blood cells, creatinine, glucose and thyroxin (T4) in the females
- vacuolization of the follicular epithelial cells of the thyroid glands of male and female rats
- increased extramedullary hematopoiesis in the spleen of male and female rats
100 ppm (7.3 mg/kg bw/day in males, 9.2 mg/kg bw/day in females)
- slight impairment of water consumption in males
- increases in total protein, albumin, globulins and cholesterol in the males
- increases in platelets and thyroid stimulating hormone (TSH) in the females - decreases in hemoglobin and triglycerides in the females - increased extramedullary hematopoiesis in the spleen of male and female rats
20 ppm (1.5 mg/kg bw/day in males, 1.9 mg/kg bw/day in females)
- no substance-related changes
In a GLP drinking water study according to OECD Guideline 407, groups of male and female Wistar rats received 20, 100 or 600 ppm of the test substance (purity unknown) for 4 weeks, followed by a recovery period of 2 weeks. The groups consisted of 13 animals per sex in the control and high dose treatment and of 8 animals per sex in the other treatments. The 20, 100 and 600 ppm values correspond to 1.5, 7.3 and 38.9 mg/kg bw in males and 1.9, 9.2 and 84.0 mg/kg bw in females, respectively.
In high dose treatment, following effects were observed: impairment of the food and water consumption and of the food efficiency; reduced body weight, mild anaemia, leucocytosis, slight impairment of hepatocellular and renal function, increased synthesis rate of serum proteins and cholesterol, substance-related changes in thyroid and spleen. In the mid dose, slight impairment of water consumption in males, increases in total protein, albumin, globulins and cholesterol in the males, increases in platelets and thyroid stimulating hormone (TSH) in the females, decreases in haemoglobin and triglycerides in the females and increased extramedullary haematopoiesis in the spleen of male and female rats were observed. In the low dose, no substance related effects were observed. In the recovery period, the effects were not fully reversible in animals of the high dose treatment. Therefore, the NOAEL is identified as 20 ppm corresponding to 1.5 mg/kg bw in males and 1.9 mg/kg in females.
Based on the spleen and thyroid effects observed in a 4-week drinking water study, the LOAEL was 100 ppm (corresponding to 7.3 and 9.2 mg/kg in males and females, respectively), the test substance is classified as STOT RE Cat 1(H372: Causes damage to organs through prolonged or repeated exposure) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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