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Provocative use tests in CAPB-allergic subjects with CAPB-containing product
M Fartasch1, T L Diepgen, M Kuhn
1Department of Dermatology, University of Erlangen, Germany.
Contact Dermatitis
|July 23, 1999
Summary
Individuals allergic to cocamidopropyl betaine (CAPB) can safely use CAPB-based rinse-off products. Studies show low risk of allergic reactions, even with impurities like dimethylaminopropylamine (DMAPA).
Area of Science:
- Dermatology
- Allergology
- Cosmetic Science
Background:
- Cocamidopropyl betaine (CAPB) is a common cause of contact allergy in personal care products.
- Impurities, particularly dimethylaminopropylamine (DMAPA), are suspected allergens, but present at very low concentrations.
Purpose of the Study:
- To evaluate if individuals with a known CAPB allergy react to CAPB in a rinse-off product during provocative use tests.
- To determine the threshold for allergic reactions to CAPB and DMAPA through patch testing.
Main Methods:
- Repeated Open Application Test (ROAT) using a 25% CAPB shower gel on 10 CAPB-allergic individuals.
- Standard patch testing with varying concentrations of CAPB and DMAPA (0.1%, 0.3%, 1%).
- Uncontrolled use testing of the CAPB-based shower gel.
Main Results:
- No subjects showed allergic reactions during the ROAT with the CAPB shower gel (DMAPA < 1 ppm).
- Patch testing revealed 5/10 subjects reacted to 1% CAPB, and only 1/10 reacted to DMAPA.
- No adverse skin reactions were reported during uncontrolled use testing.
Conclusions:
- CAPB-sensitive individuals can safely use CAPB-based rinse-off products.
- The low concentration of DMAPA in the product is unlikely to trigger allergic reactions in CAPB-sensitive individuals.
- The study validates the safety of CAPB in rinse-off formulations for allergic individuals.