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ALTERNATIVE METHODS FOR SKIN IRRITATION TESTING: THE CURRENT STATUS.

Botham1, P.A., Earl2, L.K., Fentem3, J.H., Roguet4, R., Van de Sandt5, J.J.M. 1Central Toxicology Laboratory, ZENECA, Alderley Park, Macclesfield, Cheshire SK10 4TJ, UK, 2SEAC Toxicology Unit, Unilever Research, Colworth House, Sharnbrook, Bedford MK44 1LQ, UK, 3ECVAM, JRC Environment Institute, 21020 Ispra (VA), Italy, 4L'Oreal, Life Sciences Research, 1 Avenue Eugene Schueller, 93600 Aulnay-sous-Bois, France, 5TNO Nutrition and Food Research Institute, Toxicology Division, Utrechtseweg 48, 3700 AJ Zeist, The Netherlands.
Abstract

The ECVAM Skin Irritation Task Force was established in November 1996, primarily to prepare a report on the current status of the development and validation of alternative tests for skin irritation and corrosion and, in particular, to identify any appropriate non-animal tests for predicting human skin irritation which were sufficiently well-developed to warrant ECVAM supporting their prevalidation/validation. The task force based its discussions around the proposed testing strategy for skin irritation/corrosion emanating from an OECD workshop held in January 1996. The following have been reviewed: a) structure-activity and structure-property relationships for skin corrosion and irritation: b) the use of pH and acid/alkaline reserve measurements in predicting skin corrosivity; c) in vitro tests for skin corrosion; d) in vitro tests for skin irritation (keratinocyte cultures, organ cultures and reconstituted human skin methods, and human and animal skin organ culture methods) were under development and evaluation, a test protocol, a preliminary prediction model and supporting data on different types of chemicals were only available for a method employing EpiDerm™. Thus, it is proposed that this EpiDerm test undergoes prevalidation during 1998. In addition, since it was felt preferable to be able to include other in vitro tests in such a prevalidation study, it is recommended that a “challenge” be sent to anyone interested in taking part. This involves submitting data on ten test chemicals selected by the task force, obtained according to a standard protocol with a preliminary prediction model, for review by the task force by 31 May 1998.

Keywords

Corrosion, Corrosivity, Corrosivity testing, Cutaneous irritancy, Cutaneous irritation, Cutaneous toxicity, Dermal corrosion, Dermal irritancy, Dermal irritancy testing, Dermal irritation, ECVAM, ECVAM skin irritation task force, Irritation (skin), Pre-validation, Prevalidation, Skin corrosion, Skin corrosivity, Skin irritancy, Skin irritation, Validation

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