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EC number: 943-136-4 | CAS number: -
The purpose of the present GLP study according to OECD Guideleine 423 and EU Method B.1 tris was to evaluate the potential toxic effect of the test item when administered as a single oral dose to Wistar rats. Two groups, each consisting of three female RccHan:WIST (SPF) rats, were treated with the test item by single oral gavage administration at a dose of 2000 mg/kg body weight. The test item was formulated in PEG 300 at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined daily during the acclimatisation period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2-15. Mortality/viability was recorded before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day I (with the clinical signs) and twice daily during test days 2-15. Body weights were recorded on day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and examined macroscopically. No intercurrent deaths occurred during the course of the study.
Clinical signs, including slightly to moderately increased activity, hunched posture, slightly to moderately ruffled fur and slight to moderate salivation, were observed in all animals at various time points throughout test day 1 and on test day 2. No clinical signs were observed from test day 3 onwards until the end of the study.
The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of the test item after single oral administration to female rats, observed over a period of 14 days, is: LD50 (female rat) > 2000 mg/kg bw
Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), the test item is not classified with respect to acute oral toxicity in the rat.
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