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EC number: 951-761-9 | CAS number: 55722-64-0
The study was performed according to OECD 423 and EU Method B1 tris Acute Toxicity and according to GLP to assess the acute oral toxicity of the test item following a single oral administration in the Sprague-Dawley CD strain rat by the acute class method. A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test item was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no mortalities. Clinical signs of toxicity included: hunched posture (6/6 females), lethargy (4/6), ataxia (4/6), increased salivation, (2/6), decreased respiratory rate (2/6) and noisy respiration (1/6). Females appeared normal two, three or four days after dosing. All females showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test item in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bw. Applicant assessment indicates: under the conditions of this study the acute toxicity estimate could be considered to be > 5000 mg/kg bw.
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