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EC number: 401-300-8 | CAS number: -
In a 28-day subchronic toxicity study according to OECD guideline 407, five male and five female rats were treated with the test substance by gavage at dose levels of 40, 200 and 1000 mg/kg body weight. A control group received the vehicle (distilled water containing 0.5% carboxymethyl cellulose and 0.1% Tween 80) alone. The observed parameters were the following: Clinical signs, mortality, hearing test and ophthalmologic examinations, body weight, food and water uptake, hematology, clinical chemistry, gross pathology, organ weights (limited to brain, liver, spleen, kidneys, adrenals, gonads) and histopathology (limited to spleen, heart, liver, kidney and adrenal glands). No deaths occurred during the study and no clinical symptoms or signs of systemic toxicity were observed. Eye examination and hearing test, body weight gain and food consumption revealed no changes when compared to controls. A minor increase in the percentage of segmented neutrophils was found in males and females of the high dose group (1000 mg/kg bw), but the difference to controls was not reaching a level of statistical significance. In addition, a minor (statistically not significant) increase in aspartate aminotransferase activity in males treated with 1000 mg/kg bw was observed. The analysis of organ weights and organ weights ratios revealed no consistent treatment related effect. Trends to a dose-dependent liver weight increase in males and, inversely, liver weight decrease in females, were considered to be of no experimental relevance. No treatment related findings were recorded during macroscopical and histopathological investigations. Therefore, based on the presented results and under the conditions employed, the NOAEL for the test article when administered by gavage over a period of 28 days was set at 1000 mg/kg.
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