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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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