| 1. |
- Api, Anne Marie, et al.
(författare)
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Quantitative Risk Assessment of Contact Sensitization: Clinical Data to Assess Utility of the Model
- 2010
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Ingår i: Dermatitis. - : Mary Ann Liebert Inc. - 1710-3568. ; 21:4, s. 207-213
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Tidskriftsartikel (refereegranskat)abstract
- Background: Contact hypersensitivity quantitative risk assessment (QRA) for fragrance ingredients is being used to establish new international standards for all fragrance ingredients that are potential skin sensitizers. Objective: The objective was to evaluate the retrospective clinical data on three fragrance ingredients in order to provide a practical assessment of the predictive value of the QRA approach. It is important to have data to assess that the methodology provides a robust approach for primary prevention of contact sensitization induction for fragrance ingredients identified as potential sensitizers. Methods: This article reviews clinical data for three fragrance ingredients cinnamic aldehyde, citral, and isoeugenol to assess the utility of the QRA approach for fragrance ingredients. Results: This assessment suggests that had the QRA approach been available at the time standards were established for these fragrance ingredients, the clinical response might have been noticeably improved. Prospectively, with the establishment of QRA-derived standards, there should be a continued downward trend in patch test-positive rates for cinnamic aldehyde, citral, and isoeugenol over time. Conclusion: While it is recognized that the availability of retrospective data is limited, a longitudinal review of these data gives confidence that the QRA approach should be an effective tool for primary prevention. This study also highlights the importance of continued active monitoring of clinical patch-test data for fragrance ingredients.
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| 2. |
- Svedman, Cecilia, et al.
(författare)
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A pilot study aimed at finding a suitable eugenol concentration for a leave-on product for use in a repeated open application test.
- 2012
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Ingår i: Contact Dermatitis. - : Wiley. - 0105-1873. ; 66:3, s. 137-139
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Tidskriftsartikel (refereegranskat)abstract
- Background. Knowledge of sensitization and elicitation thresholds and the time-dose relationship for elicitation of contact dermatitis is important in order to provide safe products for consumers. Objective. Since previous studies performed with eugenol had showed negative results in a repeat open application study (ROAT) study, we wanted to perform a ROAT with higher concentration (maximum allowed) and longer ROAT. Materials. 5 volunteers previously tested positive to eugenol were studied. They performed a ROAT test for maximum 4 weeks with four different solutions. Results. Four of five reacted to the maximum concentration of eugenol in the ROAT. Conclusion. In patients sensitized to eugenol, with the maximum allowed concentration of eugenol and given a prolonged ROAT (4 weeks), there is a clear risk of elicitating an allergic contact dermatitis.
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| 3. |
- Svedman, Cecilia, et al.
(författare)
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Does the New Standard for Eugenol Designed to Protect Against Contact Sensitization Protect Those Sensitized From Elicitation of the Reaction?
- 2012
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Ingår i: Dermatitis. - 1710-3568. ; 23:1, s. 32-38
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Tidskriftsartikel (refereegranskat)abstract
- Background: Potential fragrance allergens used in daily products should have a concentration limited to levels that are at, or below, acceptable exposure levels based on the quantitative risk assessment for the induction of dermal sensitization. To date, there are insufficient data to discern any quantitative relationship between induction and elicitation concentrations for fragrance ingredients that have a potential for dermal sensitization. When available, these data should be used to confirm the effectiveness of quantitative risk assessment-based risk management procedures. Objective: In this study, the relationship between the allergen concentration and the time to elicit allergic contact dermatitis in eugenol-sensitized patients was studied. The products used to elicit allergic contact dermatitis had a concentration of eugenol that was equal to, or below, the International Fragrance Association standard. Methods: Volunteers with and without known sensitization to eugenol were patch tested with various concentrations of eugenol (dilution series) and also underwent repeated open application tests (ROATs). This study model has previously been successfully used with stronger sensitizers. Results: In this study, allergic contact dermatitis, as evidenced by a positive ROAT, could not be elicited by any of the concentrations studied, including in those patients where the patch tests were positive. Conclusions: When tested in a 3-week ROAT at, or below, its current International Fragrance Association Standard, eugenol did not induce reactions even in those known to be sensitized. Whether this represents a false-negative result for a weak allergen is unknown.
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