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Updated: May 25, 2026
High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)
Published on: May 10, 2016
Patch test concentrations (doses in mg/cm2 ) for the 12 non-mix fragrance substances regulated by European
Magnus Bruze1, Cecilia Svedman, Klaus Ejner Andersen
1Department of Occupational and Environmental Dermatology, Malmö University Hospital, Lund University, S-205 02 Lund, Sweden. magnus.bruze@med.lu.se
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/cm2 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/cm2) be used for aimed and screening patch testing.
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