ALTERNATIVE METHODS FOR SKIN IRRITATION TESTING - THE CURRENT STATUS - ECVAM SKIN IRRITATION TASK-FORCE REPORT 1

The ECVAM Skin Irritation Task Force was established in November 1996, primarily to prepare a report on the current status of the developmen t and validation of alternative tests for skin irritation and corrosio n and, in particular, to identify any appropriate non-animal tests for predicting human skin irritation which were sufficiently well-develop ed to warrant ECVAM supporting their prevalidation/validation. The tas k force based its discussions around the proposed testing strategy for skin irritation/corrosion emanating from an OECD workshop held in Jan uary 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 s kin corrosivity; c) in vitro tests for skin corrosion; d) in vitro tes ts for skin irritation (keratinocyte cultures, organ cultures, and rec onstituted human skin models); and e) human patch tests for skin irrit ation. It was apparent that, although several promising candidate in v itro tests for skin irritation (for example, reconstituted human skin methods, and human and animal skin organ culture methods) were under d evelopment and evaluation, a test protocol, a preliminary prediction m odel and supporting data on different types of chemicals were only ava ilable for a method employing EpiDerm(TM). Thus, it is proposed that t his EpiDerm test undergoes prevalidation during 1998. In addition, sin ce it was felt preferable to be able to include other in vitro tests i n such a prevalidation study, it is recommended that a ''challenge'' b e set to anyone interested in taking part. This involves submitting da ta on ten test chemicals selected by the task force, obtained accordin g to a standard protocol with a preliminary prediction model, for revi ew by the task force by 31 May 1998.