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EC number: 608-818-5
CAS number: 32997-86-7
Table 1 Individual animal data on clinical
signs of toxicity and mortality
(mg/kg body weight)
Clinical Signs of Toxicity and Mortality on
Clinical Signs of Toxicity and Mortality on Day
30 to 40
All the three animals were found dead by day 2 observation
Normal; F: Female; min/mins: minutes; hr/hrs: Hour/Hours, 1: Lethargy;
29: Soft stool; 42: Recumbency
The test item was evaluated for acute oral
toxicity in Sprague Dawley rats as per OECD Guideline No. 423. A
starting dose of 300 mg/kg body weight was selected as there was no
available information on the LD50 of the test item.
A total of 9 females (3 females each per
Step-I, Step-I confirmation and Step-II) were used. All the animals of
Step-I and Step-I confirmation were administered with 300 mg/kg body
weight of the test item and Step II were administered with 2000 mg/kg
body weight of the test item by oral route (gavage).
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 observation period, all the
surviving animals were sacrificed under carbon dioxide anaesthesia,
subjected to necropsy and gross pathological examination.
In Step-I and Step-I confirmation, the
animals dosed with 300 mg/kg body weight did not reveal any clinical
signs of toxicity or mortality.
In Step-II, the animals dosed with 2000
mg/kg body weight revealed clinical signs like lethargy, soft faeces and
recumbency. All the animals were found dead by day 2 observation. No
changes were observed in body weight and percent change in body weight
with respect to day 1 at 300 mg/kg bw. All the surviving animals
revealed physiologically normal increase in the body weight.No gross
pathological changes were observed in any of the animals dosed at 300
mg/kg and 2000 mg/kg body weight.
Based on the findings of this study the acute
oral LD50 of the test item in rats is considered to be 300 < LD50 <
2000 mg/kg bw.
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