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EC number: 202-805-4
CAS number: 99-97-8
In Treated area Dose:0.5
ml of test
In Control area Dose:0.5
ml of distilled water Sex:Female
1 = Very slight erythema (barely
perceptible) 1 = Very slight oedema(barely
2 = Well defined erythema
Mean Individual Animal Score at 24,
48 and 72 hours
Body Weight (kg)
Prior to Dosing
Key: kg = kilogram
Days (Post dosing Observation)
Key: ./. = Not Applicable. 1 = Normal.
Acute Dermal Irritation/corrosion
Study of the test chemical was performed as per OECD guideline No. 404.
Three healthy young adult female New Zealand White rabbits were used.
Rabbits with good intact skin were selected for the study. The hairs of
all the rabbits were clipped at contralateral sites, approximately 24
hours prior to treatment. A dose of0.5 ml of test chemical (as such) was
applied to the skin, over an area of approximately 6 x 6 cm clipped of
hair on one side of rabbits. The other untreated side was kept as
control area and 0.5 ml of distilled water was applied at this site. At
the end of 4 hours, the gauze patch was removed and test chemical
application site was wiped with water without altering the integrity of
the epidermis. Initially, the test chemical was applied to the clipped
area of skin of one rabbit. The test site was covered with gauze patch.
At 1 hour of observation, very slight erythema (barely perceptible) and
very slight oedema (barely perceptible) was observed in animal no. 1. At
24 hour very slight erythema (barely perceptible) and no oedema was
observed. Hence the confirmatory test was conducted after 24 hours on
additional two rabbits (No. 2 and 3) to confirm the non irritant nature
of the test chemical. At 48 and72 hours observation no erythema and no
oedema was observed in animal no 1.The patch was removed after 4 hours
and rabbits were observed for erythema and oedema at 1, 24, 48 and 72
hours after patch removal, evaluated and graded as per Draize method.At
48 and 72 hours observation no erythema and no oedema was observed in
animal no 1. Animal No. 2, revealed very slight erythema (barely
perceptible) and very slight oedema (barely perceptible) observed at 1
hour of observationpost patch removal. At 24 hour well defined erythema
and very slight oedema (barely perceptible) was observed. At 48 hour
very slight erythema (barely perceptible) and no oedema was observed. At
72 hour no erythema and no oedema was observed. Animal No. 3, revealed
very slight erythema (barely perceptible) and very slight oedema (barely
perceptible) observed at 1 hour of observation post patch removal. At 24
hour very slight erythema (barely perceptible)andno oedema was observed.
At 48 and 72 hour no erythema and no oedema was observed.The individual
mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33,
1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation,
respectively. Hence, under the experimental conditions tested it was
concluded that the test chemical was Non-Irritating to the skin of
female New Zealand White rabbits and Classified as “Category- Not
Classified as Skin Irritant" as per CLP criteria.
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