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EC number: 211-889-1
CAS number: 705-86-2
Summary of Evaluation of Dermal
Laboratory Test Item Code :TAS/122/065
Test System : Sprague Dawley Rat
Sex : Female
Dose Finding Study:
Total Number of
Period of signs
From - to
No dermal reaction observed
Day 0 - Day 14
A study was designed and conducted to
determine the dermal reaction profile of the test chemical in Sprague
Dawley rats. The study was performed as per OECD Guidelines 402 and
complying to the GLP procedures.
5 female young adult, non-pregnant rats were
used for the 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 applied directly
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.
A single dose of 200 mg/kg, 1000 mg/kg and
2000 mg/kg body weight of the test item were applied to 1 female animal
respectively in the dose range finding study. Since no signs of
irritation were observed at the maximum dose of 2000 mg/kg in the test
animals, 2 additional animals were tested in the main study with 2000
mg/kg.The animals were applied with a dose of 2000 mg/kg body weight in
sequential manner at 48 hours intervals. Dermal reaction was observed
daily for study period of 14 days.
The overall irritation score of the
substance was determined to be 0 and no erythema and edema (skin
irritation) were found at the end of 14 days observation period after
Hence, it was concluded that the test
chemical was Non-Irritating to the skin of female Sprague Dawley rats
under the experimental conditions tested and classified as “Category-
Not Classified” as per CLP Classification.
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