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EC number: 700-748-4
CAS number: 1226911-69-8
an acute oral toxicity study performed according to OECD Guideline 420
and in compliance with GLP, groups (5 females/dose) of Wistar
(RccHan™:WIST) rats were given a single oral (gavage) dose of test item
at 2000 mg/kg bw. Animals
were then observed for mortality, clinical signs and bodyweights for 14
days and at the end of the study the surviving animals were sacrificed
for macroscopic examination. Sighting study was conducted at the dose
levels of 300 and 2000 mg/kg bw (one female/dose) to determine the dose
for main study.
sighting study, no mortality or clinical signs were observed at 300 and
2000 mg/kg bw. The animal showed expected gains in body weight over the
observation period. No abnormalities were noted at necropsy. In the main
study, no mortality was observed at 2000 mg/kg bw. No signs of systemic
toxicity were noted during the observation period. All animals showed
expected gains in bodyweight over the observation period. Dark liver was
noted at necropsy of one animal at 2000 mg/kg bw. No abnormalities were
noted at necropsy of the remaining animals.
Oral LD50 (females) > 2000 mg/kg bw
the experimental conditions of this study, the test item is not
classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
study is considered as acceptable and satisfies the requirement for
acute oral toxicity endpoint.
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