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Preservatives and Skin Sensitization Quantitative Risk Assessment

Basketter, David A.; Clapp, Catherine J.; Safford, Bob J.; Jowsey, Ian R.; McNamee, Pauline; Ryan, Cindy A.; Gerberick, Frank G.

doi: 10.2310/6620.2008.07018
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Background: Preservatives are an unfortunately common cause of allergic contact dermatitis (ACD). Often, this is in association with exposure to cosmetics or medicaments. Recently, a quantitative risk assessment (QRA) approach to the quantitation of safe exposure levels for sensitizers has been promulgated as a more effective tool for the identification of acceptable levels of potential sensitizers in consumer products.

Objective: To assess this QRA approach, which facilitates the prediction of acceptable exposure levels to skin sensitizers in consumer products, levels that are normally below the threshold for the induction of skin sensitization.

Methods: Retrospective QRA analysis on four preservatives in five consumer product types.

Results: The analysis shows that functional levels of preservatives may be somewhat above an ideal exposure level for some product types, an outcome that is consistent with the clinical picture.

Conclusion: QRA represents a new tool that in the future should be used in combination with the assessment of microbiologic protection needs of specific product types to limit the problem of preservative ACD.

From Unilever, Colworth House, Sharnbrook, Bedfordshire, UK; Procter & Gamble, Egham, Surrey, UK; and Procter & Gamble, Cincinnati, OH, USA.

Reprints not available.

©2008American Contact Dermatitis Society, All Right Reserved
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