Results of patch testing with five fragrance materials hitherto not tested: A dose-finding study in the clinical population.

4,8-dimethyl-4,9-decadienal (CAS 71077-31-1) allergic contact dermatitis benzaldehyde (CAS 100-52-7) fragrance contact allergy furaneol (CAS 3658-77-3) longifolene (CAS 475-20-7) quantitative risk assessment skin sensitization trans-2-hexenal (CAS 6728-26-3)

Journal

Contact dermatitis
ISSN: 1600-0536
Titre abrégé: Contact Dermatitis
Pays: England
ID NLM: 7604950

Informations de publication

Date de publication:
22 Feb 2024
Historique:
revised: 18 01 2024
received: 03 10 2023
accepted: 08 02 2024
medline: 22 2 2024
pubmed: 22 2 2024
entrez: 22 2 2024
Statut: aheadofprint

Résumé

Quantitative risk assessment (QRA) for skin sensitization is used to derive safe use levels of sensitising fragrance ingredients in products. Post-marketing surveillance of the prevalence of contact allergy to these ingredients provides relevant data to help evaluate the performance of these measures. To determine a suitable patch test concentration for five fragrance materials that had hitherto not been tested on a regular basis. These concentrations are then to be used in a surveillance study with patch testing consecutive patients over an extended monitoring period. Furaneol, CAS.3658-77-3; trans-2-hexenal, CAS.6728-26-3; 4,8-dimethyl-4,9-decadienal, CAS.71077-31-1; longifolene, CAS.475-20-7; benzaldehyde, CAS.10052-7, were patch tested with other fragrance allergens in four clinics. Patch testing was conducted in three rounds, starting with the lowest concentrations of the five ingredients. The doses were increased in the subsequent rounds if no late-appearing positive reactions and virtually no irritant reactions were reported. Overall, 373 patients were tested. No positive allergic reaction was reported to the five ingredients. Patch test results of other fragrance allergens are reported. The highest test concentrations are each considered safe for patch testing consecutive patients. Further surveillance based on these preparations will evaluate the hypothesis that QRA-driven consumer product levels of these fragrances can prevent sensitization.

Sections du résumé

BACKGROUND BACKGROUND
Quantitative risk assessment (QRA) for skin sensitization is used to derive safe use levels of sensitising fragrance ingredients in products. Post-marketing surveillance of the prevalence of contact allergy to these ingredients provides relevant data to help evaluate the performance of these measures.
OBJECTIVES OBJECTIVE
To determine a suitable patch test concentration for five fragrance materials that had hitherto not been tested on a regular basis. These concentrations are then to be used in a surveillance study with patch testing consecutive patients over an extended monitoring period.
MATERIALS AND METHODS METHODS
Furaneol, CAS.3658-77-3; trans-2-hexenal, CAS.6728-26-3; 4,8-dimethyl-4,9-decadienal, CAS.71077-31-1; longifolene, CAS.475-20-7; benzaldehyde, CAS.10052-7, were patch tested with other fragrance allergens in four clinics. Patch testing was conducted in three rounds, starting with the lowest concentrations of the five ingredients. The doses were increased in the subsequent rounds if no late-appearing positive reactions and virtually no irritant reactions were reported.
RESULTS RESULTS
Overall, 373 patients were tested. No positive allergic reaction was reported to the five ingredients. Patch test results of other fragrance allergens are reported.
CONCLUSIONS CONCLUSIONS
The highest test concentrations are each considered safe for patch testing consecutive patients. Further surveillance based on these preparations will evaluate the hypothesis that QRA-driven consumer product levels of these fragrances can prevent sensitization.

Identifiants

pubmed: 38387040
doi: 10.1111/cod.14525
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : IFRA, the International Fragrance Association

Informations de copyright

© 2024 The Authors. Contact Dermatitis published by John Wiley & Sons Ltd.

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Auteurs

Thanisorn Sukakul (T)

Department of Occupational and Environmental Dermatology, Faculty of Medicine, Lund University, Malmö, Sweden.

Wolfgang Uter (W)

Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen/Nürnberg, Erlangen, Germany.

Margarida Gonçalo (M)

Department of Dermatology, Coimbra University Hospital and Faculty of Medicine, University of Coimbra, Coimbra, Portugal.

Joseph Huggard (J)

The Huggard Consulting Group, S.A.R.L., Itzig, Luxembourg.
IFRA VP Scientific Affairs and IDEA Management Team, Brussels, Belgium.

Suzana Ljubojević Hadžavdić (S)

Department of Dermatology and Venereology, School of Medicine University of Zagreb, University Hospital Center Zagreb, Zagreb, Croatia.

Marie L A Schuttelaar (MLA)

Department of Dermatology, University Medical Center Groningen, Groningen, The Netherlands.

Cecilia Svedman (C)

Department of Occupational and Environmental Dermatology, Faculty of Medicine, Lund University, Malmö, Sweden.

Matthias Vey (M)

The Huggard Consulting Group, S.A.R.L., Itzig, Luxembourg.
IFRA VP Scientific Affairs and IDEA Management Team, Brussels, Belgium.

Marléne Isaksson (M)

Department of Occupational and Environmental Dermatology, Faculty of Medicine, Lund University, Malmö, Sweden.

Bo Niklasson (B)

Chemotechnique Diagnostics, Vellinge, Sweden.

Thomas Rustemeyer (T)

Department of Dermatology-Allergology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.

Magnus Bruze (M)

Department of Occupational and Environmental Dermatology, Faculty of Medicine, Lund University, Malmö, Sweden.

Classifications MeSH