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

Sukakul, Thanisorn LU orcid ; Uter, Wolfgang ; Gonçalo, Margarida ; Huggard, Joseph ; Ljubojević Hadžavdić, Suzana ; Schuttelaar, Marie L.A. ; Svedman, Cecilia LU ; Vey, Matthias ; Isaksson, Marléne LU and Niklasson, Bo , et al. (2024) In Contact Dermatitis 90(6). p.566-573
Abstract

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: 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: Furaneol, CAS.3658-77-3; trans-2-hexenal, CAS.6728-26-3; 4,8-dimethyl-4,9-decadienal, CAS.71077-31-1; longifolene,... (More)

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: 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: 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: 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: 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.

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organization
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Contribution to journal
publication status
published
subject
keywords
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)
in
Contact Dermatitis
volume
90
issue
6
pages
566 - 573
publisher
Wiley-Blackwell
external identifiers
  • pmid:38387040
  • scopus:85186483590
ISSN
0105-1873
DOI
10.1111/cod.14525
language
English
LU publication?
yes
id
f73b4c4f-693c-4616-b066-1ea7d1a70e70
date added to LUP
2024-03-27 10:56:15
date last changed
2024-11-07 12:18:10
@article{f73b4c4f-693c-4616-b066-1ea7d1a70e70,
  abstract     = {{<p>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: 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: 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: 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: 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.</p>}},
  author       = {{Sukakul, Thanisorn and Uter, Wolfgang and Gonçalo, Margarida and Huggard, Joseph and Ljubojević Hadžavdić, Suzana and Schuttelaar, Marie L.A. and Svedman, Cecilia and Vey, Matthias and Isaksson, Marléne and Niklasson, Bo and Rustemeyer, Thomas and Bruze, Magnus}},
  issn         = {{0105-1873}},
  keywords     = {{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)}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{566--573}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Contact Dermatitis}},
  title        = {{Results of patch testing with five fragrance materials hitherto not tested : A dose-finding study in the clinical population}},
  url          = {{http://dx.doi.org/10.1111/cod.14525}},
  doi          = {{10.1111/cod.14525}},
  volume       = {{90}},
  year         = {{2024}},
}