ALTERNATIVE METHODS FOR SKIN IRRITATION TESTING: THE CURRENT STATUS.

• TR Number: 169A
• 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

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.