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EC number: 479-930-8 | CAS number: 613222-52-9
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 exposures.
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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