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EC number: 240-970-4 | CAS number: 16919-31-6
The purpose of the study was to evaluate the potential toxic effect of the test item when administered as a single oral dose to Wistar rats. The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) Method was used. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was observed within few minutes. In
a second step, 3 females were treated at the dose of 300 mg/kg body weight. Only one animal died within five days and therefore another 3 females (third step) were treated at the same dose of 300
mg/kg body weight. Test item-related mortality was observed within 2 hours after administration of the test item. During this observation period, two animals died. In a fourth step, 3 females were treated
at the dose of 50 mg/kg body weight. All females survived 24 hours and therefore another 3 females (fifth step) were treated at the same dose of 50 mg/kg body weight. The test item administered to 3 females at a limit dose of 2000 mg/kg body caused death of 3/3 animals. Gastric erosions, hyperemia of gastrointestinal tract and splenomegaly were observed. 3/6 females survived the dose of 300 mg/kg. Lethargy and piloerection were observed during the observation period. A stagnation of body weight in one animal was observed between the first and second week after administration of the test item. During necropsy of the dead animals, the same findings as in animals which were treated with the dose of 2000 mg/kg body weight were registered. Piloerection and lethargy were noted in one animal treated with the dose of 50 mg/kg body weight, the rest animals did not display signs of toxicity during the first 4 hours and the 14-day observation period. The body weight of all survived animals increased during the study. A slight decrease of body weight in two animals and a stagnation of body weight in one animal treated with the dose of 50 mg/kg body weight were observed between the first and second week after administration of the test
item. During necropsy, no macroscopic findings were observed. The LD50 of the test item after single oral administration to Wistar rats is higher than 50 mg/kg body weight and lower than 300 mg/kg body weight.
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