Opinion on QRA SCCP 24 June 2008

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1 Opinion on QRA SCCP 24 June 2008 Jeanne Duus Johansen National Allergy Research Centre Department of Dermato-allergology Copenhagen University Hospital Gentofte Denmark

2

3 Background Many commonly used fragrance substances have a well-known sensitization potential. Necessary to establish concentration limits below which they do not pose a danger for consumers IFRA submission of documents to The Commission on the QRA approach

4 Submission

5 Terms of reference

6 Introduction IFRA standards Most concerns sensitization Historically: 1/10 of no-effect concentrations determined in experimental sensitization assays, such as Human Repeated Insult Patch Test New models Based on: Predicted no effect levels of sensitization from experimental models Safety factors Exposure assessment

7 Assessment I. Target population II. Dose-response assessment or hazard quantification III. Sensitization assessment factors (SAFs) IV. Exposure assessment V. Risk characterization VI. Confirmation of predicted use levels for fragrance ingredients VII. General discussion/summary VIII. Conclusion

8 QRA-expert group: I.a Target population

9 I.b Target population QRA-expert group: SCCP:

10 II. Dose-response assessment or hazard quantification QRA-expert group:

11 SCCP:

12 III. Sensitization assessment factor Diseased skin?

13 SAFs

14 SAFs

15 Matrix

16

17 SAFs

18 IV. Exposures

19 V. Risk characterization/limits Old IFRA standard: Isoeugenol Restricted 1998: 0.02% The QRA model allows: 0.1% in hydroalcoholic products 0.04% for shaved skin 0.01% for deodorants Out of 33 product categories: - 25 are cosmetics with skin contact in 22/25 (88%) isoeugenol will be permitted in higher concentrations Isoeugenol is often used in hydroalcoholic products were the permitted concentration will be increased and rarely in deodorants were it will be lowered.

20 Pragmatic levels

21 Pragmatic levels

22 VI. Confirmation of use levels N=3223 patients from Leuven, 133 reacting to their own products

23

24 Example Products which have caused fragrance allergy Analysis of patients ; 10.1% had a fragrance allergy Heisterberg M et al. 2011

25 Causative fragrance ingredients HICC Heisterberg M et al. 2011

26 Trend of HICC allergy 3.5 Figure 1. Prevalence of positive patch test reactions to hydroxyisohexyl 3-cyclohexene carboxaldehyde over time Subjects tested by the Danish Contact Dermatitis Group women and men men women Trend line (women and men) IFRA-limit: 1.5% 0.15% 0.02% Heisterberg M 2012

27 Relevant exposures to HICC unchanged 100 Figure 2. Frequency of clinical relevance of a positive patch test reactions to hydroxyisohexyl 3-cyclohexene carboxaldehyde overtime N= 928 with a positve patch test Current relevance Clincal relevance (past and present) present relevance past relevance Lineær (Clincal relevance (past and present))

28 Summary HRIPT lack of in-depths method description No clear guidance for the choice of test concentration No experience outside industry: reliabilty, sensitivity. Ethical concerns Does not consider protection of consumers who have already become sensitized Unclear how the QRA model covers the substantial part of the population, who suffer from skin disease (SAFs?)

29 Summary The QRA does not seem to consider: The contents of: structurally similar ingredients cocktails of allergens Aggregated exposures (from several product types) Occupational exposures

30 Summary No scientific data exist to support the levels as safe for the consumer other that the calculations in the model itself. Implementation of the model will allow increased exposure to well-known allergens in most product types compared to the current situation Use of pragmatic levels makes it difficult to use out-side industry This makes it difficult to have confidence in the model.

31 Conclusion

32 Conclusion

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