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EC number: 807-754-7 | CAS number: 89929-57-7
In an acute oral toxicity study performed according to OECD Guideline 423 and in compliance with GLP, two groups of three fasted female rats received a single oral gavage dose of the test substance, formulated in corn oil, at a dose level of 300 mg/kg bw. As results at this dose level indicated the acute (median) lethal oral dose of the test substance to be greater than 300 mg/kg bw, in compliance with the study guidelines a further two groups of three fasted females were similarly dosed at 2000 mg/kg bw to complete the study. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.
There were no deaths during the study. Clinical signs of reaction to treatment were seen in one or more animals dosed at 2000 mg/kg bw comprised of piloerection, decreased activity, unsteady gait and hunched posture. These signs were first noted on Day 1. Recovery of all animals, as judged by external appearance and behaviour, was complete by Day 3. No clinical signs were seen in any animal dosed at 300 mg/kg bw. All animals were considered to have achieved satisfactory body weight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Oral LD50 (females) >2000 mg/kg bw
Under the experimental conditions of this study, the acute median lethal oral dose (LD50) was demonstrated to be greater than 2000 mg/kg bw. Thus the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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