title: Historical perspective on the use of visual grading scales in evaluating skin irritation and sensitization.
abstract: Visual assessment of skin reactions has long been used to evaluate the safety of chemicals and preparations that contact the skin, and to meet regulatory requirements. This article reviews the history of visual grading scales, and the results of investigations into the reliability of the method. Some examples are provided to illustrate the diverse array of protocols that use visual scoring to evaluate skin irritation. Furthermore, as bioengineering methods are developed that can quantitate certain aspects of skin irritant and sensitization reactions, it is important to consider whether such measures should supplement or replace visual assessment. Examples of investigations comparing the outcomes of studies that use visual scoring and those that use bioengineering methods are discussed. These examples provide little evidence that bioengineering measures provide an improvement in overall quality in comparison with current testing methods that rely on visual assessment. In addition, such measuring techniques can add considerably to the complexity of testing protocols. When benefits and cost are weighed in the balance, the visual assessment scales popularized by Draize and others remain an effective, practical method of evaluation.
authors.affiliation: The Procter & Gamble Company, Cincinnati, 45224 OH, USA Department of Dermatology, University of California, San Francisco, CA 94102, USA. farage.m@pg.com
authors.forename: Miranda A
authors.initials: MA
authors.lastname: Farage
authors.forename: Howard I
authors.initials: HI
authors.lastname: Maibach
authors.forename: Klaus E
authors.initials: KE
authors.lastname: Andersen
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Lachapelle
authors.forename: Petra
authors.initials: P
authors.lastname: Kern
authors.forename: Cindy
authors.initials: C
authors.lastname: Ryan
authors.forename: Jeanne
authors.initials: J
authors.lastname: Ely
authors.forename: Amita
authors.initials: A
authors.lastname: Kanti
mesh_terms: D003124:Colorimetry / Q000145:classification / Q000379:methods; D017453:Dermatitis, Irritant / Q000175:diagnosis*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D010328:Patch Tests / Q000145:classification / Q000266:history* / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D023422:Skin Irritancy Tests / Q000145:classification* / Q000379:methods*