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EC number: 221-486-2
CAS number: 3115-49-9
In a maximization test according to OECD guideline 406 and
performed under QAU surveillance, the test article was tested for
sensitizing potential in Pirbright White guinea pigs. The test animals
were first induced with three pairs of intradermal injections
(adjuvant/saline; 1% test item in sesame oil; 1% test item in sesame oil
plus adjuvant/saline). One week later, the animals were treated
epicutanously for 48 hours with 3% test material in vaseline. Control
animals received the vehicle alone during induction. Two weeks after
induction, the animals were challenged by occlusive epicutaneous
exposure (0.3 % concentration) for 24 hours. During the challenge, the
control group was treated with the vehicle as well as with the test
compound to control the maximal subirritant concentration of the test
compound in adjuvant treated animals. Twenty four hours after removing
the dressings the challenge reactions were graded according the Draize
scoring scale. A second evaluation is made 48 hours after removing the
dressings. In the test group, 15/20 animals showed skin reactions,
whereas in the control group no skin reactions could be observed. In
animals treated with the vehicle alone, no skin reactions could be
observed either. The test article is therefore considered to be skin
sensitizing and requires classification. The sensitivity of the strain
is controlled every six month with p – phenylenediamine.
Dangerous Substance Directive
The available study is considered
reliable and suitable for classification purposes under 67/548/EEC. As a
result the substance requires classification with R43 for skin
sensitization under Directive 67/548/EEC.
Classification, Labeling, and
Packaging Regulation (EC) No. 1272/2008
The available experimental test data
are reliable and suitable for classification purposes under Regulation
1272/2008. As a result the substance requires classification for skin
sensitization Cat. 1A under Regulation (EC) No. 1272/2008.
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