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EC number: 451-230-7
CAS number: -
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. Hunched posture, lethargy and
ataxia were noted in three of six females during the day of dosing and
up to 24 hours after dosing. All signs ceased by 48 hours. Three of six
animals appeared normal throughout the study period. 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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