title: Skin sensitization: Implications for integration of clinical data into hazard identification and risk assessment.
abstract: Skin sensitization associated with allergic contact dermatitis is a common health problem and is an important consideration for toxicologists in safety assessment. Historically, in vivo predictive tests have been used with good success to identify substances that have the potential to induce skin sensitization, and these tests formed the basis of safety evaluation. These original tests are now being replaced gradually either by in vitro assays or by further refinements of in vivo methods such as the local lymph node assay. Human data have also been available to inform classification decisions for some substances and have been used by risk managers to introduce measures for exposure reduction. However, humans encounter hazards in the context of exposure rather than in the form of intrinsic hazards per se, and so in this article, we have examined critically the extent to which human data have been used to refine classification decisions and safety evaluations. We have also evaluated information on the burden of human allergic skin disease and used this to address the question of whether, and to what extent, the identification and evaluation of skin sensitization hazards has led to an improvement of public and/or occupational health.
authors.affiliation: DABMEB Consultancy Ltd, Sharnbrook, UK dabmebconsultancyltd@me.com.
authors.forename: D A
authors.initials: DA
authors.lastname: Basketter
authors.affiliation: Department of Cutaneous Allergy, St John's Institute of Dermatology, St Thomas' Hospital, London, UK.
authors.forename: I R
authors.initials: IR
authors.lastname: White
authors.affiliation: Department of Cutaneous Allergy, St John's Institute of Dermatology, St Thomas' Hospital, London, UK.
authors.forename: J P
authors.initials: JP
authors.lastname: McFadden
authors.affiliation: Faculty of Life Sciences, The University of Manchester, Manchester, UK.
authors.forename: I
authors.initials: I
authors.lastname: Kimber
mesh_terms: D000485:Allergens / Q000633:toxicity*; D000818:Animals; D017449:Dermatitis, Allergic Contact / Q000209:etiology*; D006801:Humans; D007509:Irritants / Q000633:toxicity; D018570:Risk Assessment; D018675:Toxicity Tests
chemical_list: D000485:Allergens; D007509:Irritants
keywords: Skin sensitization; allergic contact dermatitis; contact allergy; hazard identification; human data; regulatory classification; risk assessment