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EC number: 214-881-6
CAS number: 1205-17-0
The potential of the test material to cause acute toxicity via the oral
route was investigated using methodology equivalent or similar to the
standardised guideline OECD 401 under GLP conditions.
Following a dose range-finding study, six groups of ten Sprague Dawley
rats (five males and five females) were administered the test material
at dose levels of 1600, 2000, 2500, 3200, 3600 and 4000 mg/kg in 0.25 %
methylcellulose. The rats were observed immediately and at one and four
hours after dosing and twice daily for fourteen days for
pharmacotoxicity, CNS effects and mortality. Body
weights were recorded on the 14th day. The surviving rats were
sacrificed by CO2 inhalation and a gross necropsy performed. The
statistical method used was the method of Litchfield and Wilcoxon.
Signs observed included episodes of increased or decreased activity,
nasal discharge, diarrhoea, salivation, lacrimation, ptosis,
chromodacryorrhea, dyspnoea, decreased muscle tone, abnormal gait,
abnormal stance and prostration. None of the rats died at 1600, 2000 or
2500 mg/kg; two of ten died at 3200 mg/kg, four of ten died at 3600
mg/kg and ten of ten died at 4000 mg/kg. Necropsy of the animals dying
on study revealed distended stomachs, lesions in the stomach mucosa and
fluid-filled intestines. Congested, bright red lungs and foci on the
kidneys were also observed. No visible lesions were observed in any of
the remaining animals at terminal necropsy.
The calculated acute oral LD50 in male and female rats was determined to
be 3561 mg/kg with 95 % confidence limits of 3246 to 3906 mg/kg and a
slope of 1.11. The calculated acute oral LD50 in females was determined
to be 3362 mg/kg with 95% confidence limits of 3002 to 3766 mg/kg and a
slope of 1.1. An attempt was made to calculate the LD50 in males but the
data generated did not lend itself to the method of Litchfield and
Under the conditions of the study, the LD50 in female rats was
determined to be 3362 mg/kg with 95 % confidence limits of 3002 to 3766
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