Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials

Anne Marie Api, David Basketter, James Bridges, Peter Cadby, Graham Ellis, Nicola Gilmour, Helmut Greim, Peter Griem, Petra Kern, Alain Khaiat, John O'Brien, Thomas Rustemeyer, Cindy Ryan, Bob Safford, Benjamin Smith, Matthias Vey, Ian R. White

Research output: Contribution to journalArticlepeer-review

106 Scopus citations


In 2008, a proposal for assessing the risk of induction of skin sensitization to fragrance materials Quantitative Risk Assessment 1 (QRA1) was published. This was implemented for setting maximum limits for fragrance materials in consumer products. However, there was no formal validation or empirical verification after implementation. Additionally, concerns remained that QRA1 did not incorporate aggregate exposure from multiple product use and included assumptions, e.g. safety assessment factors (SAFs), that had not been critically reviewed. Accordingly, a review was undertaken, including detailed re-evaluation of each SAF together with development of an approach for estimating aggregate exposure of the skin to a potential fragrance allergen. This revision of QRA1, termed QRA2, provides an improved method for establishing safe levels for sensitizing fragrance materials in multiple products to limit the risk of induction of contact allergy. The use of alternative non-animal methods is not within the scope of this paper. Ultimately, only longitudinal clinical studies can verify the utility of QRA2 as a tool for the prevention of contact allergy to fragrance materials.

Original languageEnglish
Article number104805
JournalRegulatory Toxicology and Pharmacology
StatePublished - Dec 2020
Externally publishedYes


  • Aggregate exposure
  • Fragrance materials
  • Quantitative risk assessment (QRA)
  • Skin sensitization


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