title: Quantitative risk assessment for skin sensitization: Success or failure?
abstract: Skin sensitization is unique in the world of toxicology. There is a combination of reliable, validated predictive test methods for identification of skin sensitizing chemicals, a clearly documented and transparent approach to risk assessment, and effective feedback from dermatology clinics around the world delivering evidence of the success or failure of the hazard identification/risk assessment/management process. Recent epidemics of contact allergy, particularly to preservatives, have raised questions of whether the safety/risk assessment process is working in an optimal manner (or indeed is working at all!). This review has as its focus skin sensitization quantitative risk assessment (QRA). The core toxicological principles of QRA are reviewed, and evidence of use and misuse examined. What becomes clear is that skin sensitization QRA will only function adequately if two essential criteria are met. The first is that QRA is applied rigourously, and the second is that potential exposure to the sensitizing substance is assessed adequately. This conclusion will come as no surprise to any toxicologist who appreciates the basic premise that "risk = hazard x exposure". Accordingly, use of skin sensitization QRA is encouraged, not least because the essential feedback from dermatology clinics can be used as a tool to refine QRA in situations where this risk assessment tool has not been properly used.
authors.affiliation: University of Manchester, Faculty of Life Sciences, Michael Smith Building, Oxford Road, Manchester, M13 9PT, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Kimber
authors.affiliation: The Procter & Gamble Company, Central Product Safety, Mason Business Center, Mason, OH, 45040, USA. Electronic address: gerberick.gf@pg.com.
authors.forename: G Frank
authors.initials: GF
authors.lastname: Gerberick
authors.affiliation: DABMEB Consultancy Ltd, Sharnbrook, Bedfordshire, UK.
authors.forename: David A
authors.initials: DA
authors.lastname: Basketter
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D003257:Consumer Product Safety; D017449:Dermatitis, Allergic Contact / Q000209:etiology* / Q000276:immunology / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D006801:Humans; D007509:Irritants / Q000008:administration & dosage / Q000633:toxicity*; D061214:Patient Safety; D018570:Risk Assessment; D012307:Risk Factors; D012867:Skin / Q000187:drug effects* / Q000276:immunology / Q000473:pathology; D023422:Skin Irritancy Tests
chemical_list: D007509:Irritants
keywords: Contact allergy; Quantitative risk assessment; Skin sensitization