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EC number: 600-033-6
CAS number: 1001416-18-7
Intradermal induction (5 % solution):
caused slight erythema (10/10) and no (8/10) to slight (2/10) edema
formation after 24 h. Later on crust formation was observed at the
injection sites with FCA. Control animals showed no erythema and edema.
Dermal application (75 % solution):
caused no (6/10) to slight (4/10) erythema and no edema after 48 h.
Control animals showed no erythema and edema.
Challenge (60 % solution): caused
slight erythema at one animal after 24 h and slight edema in another
animal after 24 h. After 48 h the same reactions were observed at these
two animals. No reactions were observed in the remaining animals of the
test group and the control group.
Body weight development was positive and
within normal range.
The skin sensitising potential of the
substance was assessed in ten female guinea pigs of the strain Pirbright
White. The test was performed according to the protocol of Magnusson and
Kligman, the challenge application was executed with Duhring chambers
to aim for better exposure conditions. The test protocol is in
compliance with OECD Guideline 406.
The maximum compatible doses for the
intradermal and dermal application as well as the subirritative dose for
the challenge were determined in a pilot experiment.
In the main experiment 10 female guinea pigs
were treated intradermally with 0.1 ml of a 5 % (w/w) dilution of the
test substance in sesam oil. For the dermal induction a 75 % (w/w)
dilution of the test substance in sesam oil was used. Intradermal
application of the 5 % (w/w) dilution of the tests ubstance in sesame
oil and the topical application of the 75 % (w/w) dilution of the test
substance caused very slight erythema and edema formation.
In the challenge the test substance elicited
a very slight erythema at one animal after 24 hours. A very slight edema
was obsrved after 24 hours in another animal. After 48 hours the same
reactions were observed at these two animals. No erythema or edema
formation were observed in the remaining animals of the test group and
in the control group 24 hours and 48 hours post application. Thus, the
sensitisation rate for the tests substance was 20 %. The substance has
therefore to be regarded as mildly sensitising under the applied test
conditions when exposed to the skin of experimental animals.
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