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EC number: 479-930-8
CAS number: 613222-52-9
Dermal response scores for Guinea pigs
challenged with the test item:
SCORES OF DERMAL REACTION
after the patch removal
number of positive/
number of tested
Scoring of Skin Sensitisation
0 = no visible change
1 = discrete or patchy erythema
2 = moderate and confluent
3 = intense erythema and swelling
SIKA Hardener LH was tested for skin
sensitising properties in a guinea pig maximisation test according to EU
method B.6 and OECD guideline 406. A guinea pig maximisation test (GPMT)
skin sensitisation study was performed according to the Magnusson and
-Kligman method, using Freund's complete adjuvant technique, to evaluate
the sensitisation potential of test item SIKA Hardener LH.
A total of 10 test animals were subjected to
sensitisation procedures in a two-stage operation, i.e. an intra-dermal
treatment and a topical application. The test item was administered at a
concentration of 5 % for intra dermal injections and in undiluted state
for dermal sensitisation treatments. The test area was painted with 0.5
ml of 10 % sodium dodecyl sulphate in vaseline 24 h prior to the topical
induction application in order to create a local irritation. Two weeks
following the last induction exposure a challenge dose (in undiluted
state) was administered. Challenge was performed by dermal application
of the test item.
Concurrent to treatment animals, 5 control
guinea pigs were exposed to the vehicle only, during the sensitisation
phase, and treated with the test item (in undiluted state) in challenge
A response, indicating sensitising effects,
was observed in 40 % of the treatment group animals after challenge
application of the test item. Challenge with the test item elicited
intense, confluent erythema and swelling (scores 2-3) in guinea pigs
previously sensitized with test item. No response was observed in
concurrently challenged control group animals. In summary, SIKA Hardener
LH was considered sensitising to skin.
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