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EC number: 233-634-3
CAS number: 10287-53-3
The numerical scores awarded to the dermal reactions elicited by the
challenge were all 0. There were no dermal reactions seen in any of the
test or control animals at any time point.
The skin sensitisation potential of the test material was investigated
in accordance with the standardised guidelines OECD 406 and EU Method B6
using the guinea-pig maximisation test.
Preliminary investigations were performed to assess the intradermal and
topical irritancy of a range of dilutions of the test material. The
doses selected for the induction part of the main study were 10 % (w/w)
in liquid paraffin for intradermal injection and 40 % (w/w) in liquid
paraffin for topical application. In the challenge portion of the study,
20 and 10 % (w/w) in liquid paraffin were applied to an anterior site
and posterior site, respectively.
Twenty female guinea-pigs were assigned to the test group and ten to the
control group for the main study. During induction, three pairs of
intradermal injections (0.1 mL each) were made simultaneously: Freund’s
complete adjuvant diluted with an equal volume of water for irrigation;
the test material at 10 % (w/w) in liquid paraffin; and the test
material at 10 % (w/w) in a 50:50 mixture of Freund’s complete adjuvant
and liquid paraffin. One week after the injections, the same area was
exposed to the test material at 40 % (w/w) in liquid paraffin for 48
hours. Control animals were treated similarly to the test animals with
the exception that the test material was omitted from the application
The test and control animals were challenged topically two weeks after
the induction period using the test material at 20 and 10 % (w/w) in
liquid paraffin for 24 hours. The challenge sites were evaluated 24, 48
and 72 hours after removal of the patches.
Under the conditions of the study the test material is not considered to
be a skin sensitiser.
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