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EC number: 430-150-6
CAS number: -
In an acute oral toxicity study (limit
test), performed according to OECD Guideline No. 401 and in compliance
with GLP, a group of Sprague Dawley OFA rats (5/sex) were administered a
single oral dose of test material suspended in 0.5 %
carboxymethylcellulose at 2000 mg/kg bw under a constant volume of 5
mL/kg bw by gavage. 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.
No mortality or clinical signs were
observed. All animals showed normal body weight gains after the 14 day
study period. No abnormalities were noted at autopsy.
Oral LD50 Combined > 2000 mg/kg bw
Under the test conditions, the test material
is not classified according to the Annex VI of the Regulation (EC) No.
1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and is not
classified according to the GHS since there is no reliable evidence that
indicates the LD50 to be in the range of Category 5 values (GHS criteria
This study is considered as acceptable and
satisfies the requirement for acute oral toxicity endpoint.
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