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EC number: 202-705-0
CAS number: 98-83-9
The key study was performed to assess the skin sensitization potential
of the test item in the CBA/Ca strain mouse following topical
application to the dorsal surface of the ear (LLNA, OECD 429).
The Stimulation Index expressed as the mean radioactive incorporation
for each treatment group divided by the mean radioactive incorporation
of the vehicle control group are as follows:
Test item is to be considered as a sensitizer under the conditions of
the test. The concentration of test item expected to cause a 3 -fold
increase in 3HTdR incorporation (EC3 value) was calculated to be 46%.
to Regulation 1272/2008 on Classification, Labelling and Packaging, a SI
(stimulation index) of 3 or more is considered a positive response. The
EC3 represents that concentration which is needed to produce an SI of 3.
Based on this Regulation the following distinction is made:
value ≤ 2 %: Sensitiser Category 1A
value > 2%: Sensitiser Category 1B
the EC3 of the test item is 46%, it was concluded that
to be classified as Skin Sensitiser Category 1B according to Regulation
1272/2008 on Classification, Labelling and Packaging.
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