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- Bruze, Magnus, et al.
(author)
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Patch test concentrations (doses in mg/cm(2) ) for the 12 non-mix fragrance substances regulated by European legislation.
- 2012
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In: Contact Dermatitis. - : Wiley. - 0105-1873 .- 1600-0536. ; 66:3, s. 131-136
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Journal article (peer-reviewed)abstract
- Background. According to EU legislation, 26 fragrance substance allergens must be labelled on cosmetic products. For 12 of them, the optimal patch test concentration/dose has not been evaluated. Objectives. To establish the optimal patch test doses in mg/cm(2) for the 12 fragrance substances that are not included in fragrance mix I or II in the European baseline patch test series. Materials and Methods. Patch testing with the 12 fragrance substances was performed in a stepwise manner encompassing up to five rounds in at least 100 dermatitis patients for each round. Before patch testing, an individual maximum concentration/dose was determined for each fragrance substance. Results. The predetermined maximum patch test concentrations/doses could be tested for all 12 fragrance substances, with no observable adverse reactions being noted. Conclusions. For each fragrance substance investigated, it is recommended that half of the maximum patch test dose (mg/cm(2) ) be used for aimed and screening patch testing.
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- Ofenloch, Robert F., et al.
(author)
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Allergic reactivity for different dilutions of eugenol in repeated open application test and patch testing
- 2023
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In: Contact Dermatitis. - 0105-1873. ; 89:2, s. 95-102
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Journal article (peer-reviewed)abstract
- Background: Eugenol is a known contact sensitiser included in fragrance mix I. Objective: To assess the allergic reactivity to eugenol in different concentrations using patch test as well as repeated open application test (ROAT). Methods: Overall 67 subjects from 6 European dermatology clinics participated in the study. The ROAT was performed for 21 days twice a day, applying 3 dilutions of eugenol (2.7%–0.5%) and a control. Before and after the ROAT, patch testing with 17 dilutions of eugenol (2.0%–0.00006%) and controls was performed. Results: Out of the 34 subjects with contact allergy to eugenol, 21 (61.8%) showed a positive patch test before ROAT was performed, the lowest positive concentration was 0.031%. The ROAT was positive in 19 (55.9%) of the 34 subjects, the time until a positive reaction occurred was negatively associated with the concentration of the ROAT solution, as well as with the allergic reactivity of the subjects as defined by patch testing. In the patch test after ROAT, 20 of the 34 test subjects (58.8%) showed a positive reaction. In 13 (38.2%) of the 34 test subjects, the patch test result was not reproduceable, still 4 (31.0%) of these 13 subjects developed a positive ROAT. Conclusion: Eugenol can provoke a positive patch test reaction in a very low dose; besides, this hypersensitivity may persist even if a former positive patch test is not reproduceable.
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