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EC number: 948-498-7
CAS number: 143785-33-5
Oral LD50 is >2000 mg/kg bw
Acute oral toxicity:
In an acute oral toxicity study performed
according to OECD 423, the test substance was administered via oral
gavage to female Sprague Dawley rats. A starting dose of 300 mg/kg bw
was selected since there was no available data on acute toxicity of the
test item. A total of 12 females (3 females for each step: Step-I,
Step-I confirmation, Step-II and Step-II confirmation) were used for the
experiment. Animals of "Step-I" and "Step-I confirmation" were
administered 300 mg/kg bw of the test item and the animals of "Step-II"
and "Step-II confirmation" were administered 2000 mg/kg bw of the test
item. All the animals were observed for clinical signs of toxicity and
mortality at 30 to 40 min, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10
mins) and 4 hrs (±10 mins) post dosing on Day 1 and once daily
thereafter for clinical signs of toxicity and twice daily for mortality
during the 14 days observation period. Body weight was recorded on Day 1
before test item administration and on day 8 and 15 during the
observation period. At the end of the observation period, all the
animals were sacrificed under carbon dioxide anaesthesia, subjected to
necropsy and gross pathological examination. No clinical signs of
toxicity and mortality was observed at 300 and 2000 mg/kg bw. All the
animals revealed a physiologically normal increase in body weight. All
the animals revealed a physiologically normal increase in body weight.
No gross pathological changes were observed in any of the animals at 300
and 2000 mg/kg bw. Based on the results of the experiment, it is
concluded that the LD50 cut off value for the test item is 5000 mg/kg bw
when administered as a single dose by oral gavage to female Sprague
The test substance does not have to be classified for acute oral
toxicity according to Regulation (EC) No 1272/2008.
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