title: Quantitative risk assessment of contact sensitization: clinical data to assess utility of the model.
abstract: BACKGROUND
  Contact hypersensitivity quantitative risk assessment (QRA) for fragrance ingredients is being used to establish new international standards for all fragrance ingredients that are potential skin sensitizers.
  
  
  OBJECTIVE
  The objective was to evaluate the retrospective clinical data on three fragrance ingredients in order to provide a practical assessment of the predictive value of the QRA approach. It is important to have data to assess that the methodology provides a robust approach for primary prevention of contact sensitization induction for fragrance ingredients identified as potential sensitizers.
  
  
  METHODS
  This article reviews clinical data for three fragrance ingredients-cinnamic aldehyde, citral, and isoeugenol-to assess the utility of the QRA approach for fragrance ingredients.
  
  
  RESULTS
  This assessment suggests that had the QRA approach been available at the time standards were established for these fragrance ingredients, the clinical response might have been noticeably improved. Prospectively, with the establishment of QRA-derived standards, there should be a continued downward trend in patch test-positive rates for cinnamic aldehyde, citral, and isoeugenol over time.
  
  
  CONCLUSIONS
  While it is recognized that the availability of retrospective data is limited, a longitudinal review of these data gives confidence that the QRA approach should be an effective tool for primary prevention. This study also highlights the importance of continued active monitoring of clinical patch-test data for fragrance ingredients.
authors.affiliation: Research Institute for Fragrance Materials, Woodcliff Lake, NJ 07677, USA. amapi@rifm.org
authors.forename: Anne
authors.initials: A
authors.lastname: Marie Api
authors.forename: Donald
authors.initials: D
authors.lastname: Belsito
authors.forename: David
authors.initials: D
authors.lastname: Bickers
authors.forename: Magnus
authors.initials: M
authors.lastname: Bruze
authors.forename: Peter
authors.initials: P
authors.lastname: Calow
authors.forename: Helmut
authors.initials: H
authors.lastname: Greim
authors.forename: Jon M
authors.initials: JM
authors.lastname: Hanifin
authors.forename: Pauline M
authors.initials: PM
authors.lastname: McNamee
authors.forename: Adrianne E
authors.initials: AE
authors.lastname: Rogers
authors.forename: Jean-Hilaire
authors.initials: JH
authors.lastname: Saurat
authors.forename: I Glenn
authors.initials: IG
authors.lastname: Sipes
authors.forename: Hachiro
authors.initials: H
authors.lastname: Tagami
mesh_terms: D000171:Acrolein / Q000009:adverse effects / Q000031:analogs & derivatives*; D000080462:Acyclic Monoterpenes; D003257:Consumer Product Safety / Q000592:standards; D017449:Dermatitis, Allergic Contact / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology*; D005054:Eugenol / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D039821:Monoterpenes / Q000009:adverse effects*; D010328:Patch Tests; D010476:Perfume / Q000009:adverse effects* / Q000592:standards; D018570:Risk Assessment
chemical_list: D000080462:Acyclic Monoterpenes; D039821:Monoterpenes; D010476:Perfume; D005054:Eugenol; C036643:isoeugenol; D000171:Acrolein; C012843:cinnamaldehyde; C007076:citral