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EC number: 265-745-8
CAS number: 65405-77-8
Volunteer no. 20 discontinued the study after three week due to personal
reasons. The challenge phase therefore was carried out of 49 volunteers.
Results of the Standard Products
For the empty test plaster, four slight reactions of erythema were
documented. For deionised water, seven slight and three moderate
reactions of erythema were documented. Standard product L caused five
slight reactions and one moderate reaction of erythema during the test.
Five slight reactions were documented for the standard product N. The
standard product which caused the highest amount of reaction points
(standard L) that six reactions could be expected with the test material
and be very well tolerated by the skin. However most of the reactions
should be slights and only be seen by single volunteers. The application
of the positive control SDS (0.05% in water) causes in the first week
ten slight reactions of erythema grade 1. In the second week 39 slight
and five moderate reactions of erythema were documented. In the third
week, 49 slight reactions and six moderate reactions were noticed.
Additionally two intense reactions occurred. In the challenge phase 12
slight reactions and two moderate reactions of erythema of grade 1 were
Results of the Test Products
The test product HR 00/600301A (15% test substance in EtOH/DEP 1:1)
caused two slight reactions without dermatological relevance during the
observation period. Therefore the test product HR 00/600301 A is
considered to be very well tolerated by the skin. The test product HR
00/160217 (EtOH/DEP 1:1) caused two slight reactions during the second
week of application. Both reactions were slight and without
dermatological relevance, the test substances was determined to be very
well tolerated by the skin. The test product HR 00/622501B (8% in
EtOH/DEP 1:1) caused no reaction during the challenge phase. The
substance was determined to be very well tolerated by the skin.
Table 4: Summary of induction reactions
The skin sensitisation potential of the test substance was assessed in
50 volunteers using repeated application closed patch epicutaneous
testing under occlusion. Informed written consent was sought prior to
study initiation. The test substance was found to be very well tolerated
by the skin under the conditions of the test at 8% and 15%
concentrations in EtOH/DEP 1:1.
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