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EC number: 606-790-9
CAS number: 215247-95-3
The primary skin irritation potential of the
test item was investigated according to OECD test guideline no. 404. The
test item was applied by topical semi-occlusive application of 0.5 g to
the intact flank of each of three young adult New Zealand White rabbits.
The duration of treatment was four hours. The scoring of skin reactions
was performed 30 - 60 min, 24, 48 and 72 hours after removal of the
dressing. The mean score was calculated across 3 scoring times (24, 48
and 72 hours after patch removal) for each animal for erythema/eschar
grades and for oedema grades, separately. The application of the test
item to the skin resulted in mild, early-onset and transient signs of
irritation such as erythema. These effects were reversible and were no
longer evident 24 hours after treatment for all animals. Staining of the
treated skin was noted in all animals throughout the whole study. No
corrosive effects were noted on the treated skin of any animal at any of
the measuring intervals and no clinical signs were observed. Thus, the
test item did not induce significant or irreversible damage to the skin.
Based upon the referred classification criteria (Commission Directive
84/449/EC of April 1984), the test item is considered to be "not
irritating" to rabbit skin.
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