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EC number: 214-901-3
CAS number: 1208-67-9
Animal -Clinical Signs of
Toxicity and Mortality
: Sprague Dawley Rat
Sex : Male
Total Number of
Period of signs in days
From - to
No clinical signs observed
Day 0 - Day 14
Sex : Female
Animal - Evaluation of Dermal Reaction
Sex : Male
Group : I
Dose : 2000 mg/kg
D A Y S
Sex : Female
Animal - Body Weight and Percent Body Weight Gain (g)
Body weight Day 0
Body weight Day 7
% body weight gain
Body weight Day 14
day 7- 14
day 0- 14
Day 7- 14
Individual Animal - Gross Pathological
Gross Pathological Findings
No abnormality detected
TS = Terminal sacrifice
A study was designed and conducted to
determine the dermal Irritation/corrosion potential of the test chemical
in Sprague Dawley rats. This study was performed as per OECD guideline
No. 402. Ten rats (5 male and 5 female) were used for conducting dermal
irritation/ corrosion study.
The animals were kept in their cages
for at least 5 days prior to administration for acclimatization to the
laboratory condition and after acclimatization period, animals were
randomly selected. Approximately 24 hours before application, the hair
of each rat was closely clipped from the trunk (dorsal surface and sides
from scapular to pelvic area) with an electric clipper, so as to expose
at least 10% of the body surface area. The test item was moistened with
distilled water. The test item was applied onto the exposed skin of the
animal, taking care to spread the test item evenly over the entire area
of approximately 10% of the total body surface area or as much of the
area as can reasonably be covered. The test item was held in contact
with the skin using a porous gauze dressing and non irritating tape
around the animal to cover the exposure site for first 24 hours exposure
period. Elizabethan collar was placed on each animal for first 24 hours
after application of the test item. These collars prevent ingestion of
test item. Following 24 hours of exposure, the wrapping was removed and
the test site wiped free of excess test item. Distilled water was used
to remove residual test item.
The test chemical was applied to shorn
skin of 5 male and 5 female animals at 2000 mg/kg body weight.
Administration of the test item at 2000 mg/kg did not result in any skin
reaction at the site of application during the study period of 14 days.
Also, the erythema and edema score of rats was calculated as 0.
Administration of the test item did not result in any signs of toxicity
and mortality during the study period of 14 days. Animals exhibited
normal body weight gain through the study period of 14 days. Gross
pathological examination did not reveal any abnormalities attributable
to the treatment.
Hence, it was concluded that the test
chemical was Non-Irritating to the skin of Sprague Dawley rats under the
experimental conditions tested and Classified as “Category- Not
Classified” as per CLP Classification.
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