Patch test concentrations (doses in mg/cm2 ) for the 12 non-mix fragrance substances regulated by European legislation

Contact Dermatitis. 2012 Mar;66(3):131-6. doi: 10.1111/j.1600-0536.2011.02037.x.

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/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.

MeSH terms

  • Adult
  • Allergens* / adverse effects
  • Cosmetics* / adverse effects
  • Dermatitis, Allergic Contact / diagnosis*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patch Tests / methods*
  • Perfume* / adverse effects

Substances

  • Allergens
  • Cosmetics
  • Perfume