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Contact Dermatitis. 2011 Apr;64(4):203-11. doi: 10.1111/j.1600-0536.2010.01863.x.

Is cocamidopropyl betaine a contact allergen? Analysis of network data and short review of the literature.

Author information

1
Information Network of Departments of Dermatology, University of Göttingen, Von Siebold Strasse 3,Göttingen/Germany. aschnuch@med.uni-goettingen.de

Abstract

BACKGROUND:

There is no general agreement on whether cocamidopropyl betaine (CAPB) is a skin sensitizer.

OBJECTIVE:

To examine the evidence for CAPB being a (non-)sensitizer.

METHODS:

This was a retrospective analysis of data on patch testing with CAPB 1% aqua collected by the Information Network of Departments of Dermatology from 1996 to 2009, with a focus on the patch test reaction profile, and demographic and clinical features of CAPB positives, supplemented by a literature review.

RESULTS:

Eighty-three thousand eight hundred and sixty-four patients were patch tested with CAPB 1% aqua, yielding 2.16% [95% confidence interval (CI) 2.06-2.26%] positive (2.03% + and 0.13% + + /+ + + ) and 4.6% non-allergic reactions. Thus, the reaction index was-0.368 and the positivity ratio was 94.2%. Reproducibility on synchronous patch testing (n = 6534) was poor [Cohen's kappa: 0.29 (95% CI 0.25-0.32)] and results upon retesting (n = 1157) were almost non-reproducible [kappa: 0.12 (95% CI 0.05-0.19]. Multifactorial logistic regression analysis revealed an increased risk associated with being male and aged ≥40 years, with atopic dermatitis, with scalp dermatitis, with being a hairdresser, and with a 48-hr patch test application. When only + + or + + + reactions were used as a conservative outcome, only the elevated risk in males and in patients with atopic dermatitis remained significant.

CONCLUSION:

The vast majority of positive reactions to CAPB are presumably false positive. Allergic reactions are very rare. This would support the notion of CAPB being 'not a significant skin sensitizer', in line with current classification systems.

[Indexed for MEDLINE]

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