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EC number: 239-311-3
CAS number: 15267-95-5
Skin sensitisation (OECD 406 / Buehler Test): sensitising
In the available key study (Harlan, 2012d)
the test item was tested for skin sensitising properties according to
the OECD TG 406 and in compliance with GLP. Twenty male Albino Dunkin
Hartley guinea pigs of the test group were treated topically with 100%
test item once a week for a 3-week induction phase. Two weeks after the
last induction, the animals were challenged with 100% and 50% test item
in diglyme (vehicle). The ten animals of the control group were not
treated with test item or vehicle during the induction. The animals were
challenged with 100% and 50% test item in diglyme. No skin reactions
were observed in any of the control animals.
Discrete or patchy erythema were observed in
one animal of the test group at the third induction with 100% of test
item. No skin reactions were observed in any of the control animals
after the challenge with 100% test item or with 50% test item in
diglyme. One animal of the test group showed discrete or patchy erythema
at the 24 h reading after the challenge with 100% test item or with 50%
test item in diglyme. Five animals showed discrete or patchy erythema
and one animal showed moderate and confluent erythema at the 48 h
reading after the challenge with 100% of test item. Two animals of the
test group showed discrete or patchy erythema at the 48 h reading after
the challenge with 50% test item in diglyme. Hence, as the test material
produced skin reactions in 30% of the test animals after the challenge
in a non-adjuvant sensitisation test in guinea pigs, the test item is
considered to be a skin sensitiser.
The available data are reliable and suitable
for classification. Based on these data, the test item has to be
classified as a skin sensitiser (Cat 1B) according to EC/1272/2008.
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