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EC number: 213-384-1
CAS number: 941-98-0
Table No. I
Summary of Clinical Signs of
Toxicity and Mortality
Laboratory Test Item Code :TAS/122/059
Test System : Sprague Dawley Rat
Sex : Female
Dose Finding Study:
Total Number of
Period of signs in days
From - to
No clinical signs observed
Day 0 - Day 14
Table No. II
Summary of Evaluation of Dermal
Period of signs
No dermal reaction observed
Mean Body Weight and Percent Body
Weight Gain (g)
(mg/kg body weight)
Body weight Day 0
Body weight Day 7
% body weight gain
Body weight Day 14
day 7- 14
day 0- 14
Summary of Gross Pathological
Gross Pathological Findings
No abnormality detected
TS = Terminal
The reported study was designed and
conducted to determine the acute dermal toxicity profile of the given
test chemical as per OECD Guideline 402 (Acute Dermal Toxicity) in
Sprague Dawley rats.
In the dose range finding study a
single dose of 200 mg/kg body weight of the test item was administered
to 1 female animal. No death or clinical signs of toxicity was observed
during first 48 hours, hence, additional 1 female animal was
administered with the dose of 1000 mg/kg body weight. Administration of
1000 mg/kg body weight did not reveal any clinical signs of toxicity or
death during first 48 hours, hence, additional 1 female animal was
administered at the dose of 2000 mg/kg body weight. Administration of
2000 mg/kg body weight did not reveal any clinical signs of toxicity or
death during first 48 hours.
As the dose range finding study
revealed no mortality or clinical signs at the maximum dose of 2000
mg/kg, the main study was initiated with two additional animals. The
animals were administered with a dose of 2000 mg/kg body weight in
sequential manner at 48 hours intervals.
Animals from dose range finding study
treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and
animals from main study treated at the dose level of 2000 mg/kg
exhibited normal body weight gain and revealed no clinical signs of
toxicity or mortality during the study period of 14 days. Gross
pathological examination did not reveal any abnormalities attributable
to the treatment.
It was concluded that the acute dermal
median lethal dose (LD50) of the given test chemical, when administered
to female Sprague Dawley rats was considered to be >2000 mg/kg body
weight. Thus, according to CLP criteria for acute toxicity rating for
the chemicals, it infers that the given test chemical does not classify
as an acute dermal toxicant. CLP Classification: “Not classified”.
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