title: The classification of skin irritants by human patch test.
abstract: The human 4 hour patch test provides an opportunity to identify substances with significant skin irritation potential without recourse to the use of animals. The protocol is designed to avoid the production of more than mild irritant reactions and meets the highest ethical standards. This paper provides the background to the development of the method and comments on its performance in the light of recent intra- and inter-laboratory investigations. In particular, the value of the method in providing 'gold standard' data for the identification of those substances (or preparations) which should, or should not, be classified as irritant to skin in European legislation is discussed. On the basis of the published data and supplementary investigations, recommendations are made on both the conduct and interpretation of the human 4 hour patch test. Finally, the lack of any necessity for formal validation of this assay is addressed.
authors.affiliation: Unilever Environmental Safety Laboratory, Sharnbrook, Bedford, UK.
authors.forename: D A
authors.initials: DA
authors.lastname: Basketter
authors.forename: M
authors.initials: M
authors.lastname: Chamberlain
authors.forename: H A
authors.initials: HA
authors.lastname: Griffiths
authors.forename: M
authors.initials: M
authors.lastname: Rowson
authors.forename: E
authors.initials: E
authors.lastname: Whittle
authors.forename: M
authors.initials: M
authors.lastname: York
mesh_terms: D006287:Health Planning Guidelines; D006801:Humans; D006969:Hypersensitivity, Immediate; D007509:Irritants / Q000145:classification* / Q000633:toxicity; D015337:Multicenter Studies as Topic; D010328:Patch Tests / Q000379:methods*; D015203:Reproducibility of Results; D012621:Seasons; D012867:Skin / Q000187:drug effects* / Q000473:pathology
chemical_list: D007509:Irritants