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EC number: 254-996-9
CAS number: 40601-76-1
Recent and well-conducted guideline studies in rats indicate no significant toxicity up to limiting doses of 2000 mg/kg bw either by the oral or dermal routes of exposure.
a GLP compliant acute oral toxicity study, performed according to OECD
guideline 423, the
test item was administered to
Sprague Dawley rats ata
single dose level of 2000 mg/kg bw.
mortalities or clinical signs were noted.
conclusion, the LD50 ofthe
body weight by oral route in the rat.
An acute dermal toxicity test with male and female rats was performed
under GLP principles. The rats were exposed occlusively for 24 hours to
2000 mg/kg bw and observed for 14 days after removal of the test
substance. No mortality, clinical signs or particular findings at
necropsy were observed.
Based on these results, the LD50 of the test substance was found to be >
2000 mg/ kg bw and therefore the test substance is not classified.
Acute Oral Toxicity
In an earlier non-guideline study, 10 male Wistar rats
were treated with a single dose of 10 g/kg bw and observed for signs of
toxicity for 14 days. The were no adverse effects reported in this
study. The LD50 was reported as > 10,000 mg/kg bw. In a recent study
conducted according to OECD Guideline 423, 6 female Wistar rats were
treated up to a limit dose of 2000 mg/kg bw and observed for signs of
toxicity for 14 days. There was no mortality or other toxicologically
relevent abnormalities reported in this study. The LD50 was reported as
> 2000 mg/kg bw.
Acute Dermal Toxiciy
In an earlier non-guideline study, 5 male albino rabbits
were administered 5000 mg/kg bw dermally under semi-occlusive wrap and
animals were then observed for signs of toxicity for 14 days. There was
no mortality, signs of intoxication or irritation. No clinical signs
were noted. The LD 50 was reported as > 5000 mg/kg bw. In a recent
guideline study, groups of 5 male and female Wistar rats were
administered 2000 mg/kg bw dermally under occlusive wrap. The exposure
duration was 24 h after which the animals were observed for signs of
toxicity for 14 days. There was no mortality and no abnormalities found
at macroscopic examination at study termination. The LD 50 was reported
as > 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
A recent study conducted according to OECD Guideline 423 (Acute
Toxicity Class Method).
Justification for selection of acute toxicity – dermal endpoint
A recent study conducted according to OECD Guideline 402 (Acute
In well-conducted oral and dermal acute toxicity studies
in experimental animals, there was no significant toxicity noted. Thus,
no classification for acute toxicity is warranted. Also, no
classification for STOT (single) is warranted.
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