title: Comparative sensitizing potencies of fragrances, preservatives, and hair dyes.
abstract: The local lymph node assay (LLNA) is used for assessing sensitizing potential in hazard identification and risk assessment for regulatory purposes. Sensitizing potency on the basis of the LLNA is categorized into extreme (EC3 value of ≤0.2%), strong (>0.2% to ≤2%), and moderate (>2%). To compare the sensitizing potencies of fragrance substances, preservatives, and hair dye substances, which are skin sensitizers that frequently come into contact with the skin of consumers and workers, LLNA results and EC3 values for 72 fragrance substances, 25 preservatives and 107 hair dye substances were obtained from two published compilations of LLNA data and opinions by the Scientific Committee on Consumer Safety and its predecessors. The median EC3 values of fragrances (n = 61), preservatives (n = 19) and hair dyes (n = 59) were 5.9%, 0.9%, and 1.3%, respectively. The majority of sensitizing preservatives and hair dyes are thus strong or extreme sensitizers (EC3 value of ≤2%), and fragrances are mostly moderate sensitizers. Although fragrances are typically moderate sensitizers, they are among the most frequent causes of contact allergy. This indicates that factors other than potency need to be addressed more rigorously in risk assessment and risk management.
authors.affiliation: Institute of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden. carola.liden@ki.se.
authors.forename: Carola
authors.initials: C
authors.lastname: Lidén
authors.affiliation: Institute of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden.
authors.forename: Kerem
authors.initials: K
authors.lastname: Yazar
authors.affiliation: Department of Dermato-Allergology, National Allergy Research Centre, Copenhagen University Hospital Gentofte, 2900 Hellerup, Denmark.
authors.forename: Jeanne D
authors.initials: JD
authors.lastname: Johansen
authors.affiliation: Department of Chemistry and Molecular Biology, Dermatochemistry, University of Gothenburg, 405 30 Gothenburg, Sweden.
authors.forename: Ann-Therese
authors.initials: AT
authors.lastname: Karlberg
authors.affiliation: Department of Medical Informatics, Biometry and Epidemiology, Friedrich-Alexander-University Erlangen/Nürnberg, 91054 Erlangen, Germany.
authors.forename: Wolfgang
authors.identifier: http://orcid.org/0000-0002-4498-3710
authors.initials: W
authors.lastname: Uter
authors.affiliation: Department of Cutaneous Allergy, St John's Institute of Dermatology, Guy's Hospital, London SE1 9RT, UK.
authors.forename: Ian R
authors.initials: IR
authors.lastname: White
mesh_terms: D000485:Allergens / Q000633:toxicity*; D000818:Animals; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D004195:Disease Models, Animal; D004305:Dose-Response Relationship, Drug; D006202:Hair Dyes / Q000633:toxicity*; D007114:Immunization; D023441:Local Lymph Node Assay; D010476:Perfume / Q000633:toxicity*; D011310:Preservatives, Pharmaceutical / Q000633:toxicity*; D018570:Risk Assessment; D012882:Skin Tests
chemical_list: D000485:Allergens; D006202:Hair Dyes; D010476:Perfume; D011310:Preservatives, Pharmaceutical
keywords: EC3 value; Scientific Committee on Consumer Safety; fragrances; hair dyes; hazard; preservatives; risk assessment