Alternative Methods for Skin Irritation Testing. The Current Status.

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 measurementsin 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 models); and (e) human patch tests for skin irritation. It was apparent that, although several promising candidate IN VITRO tests for skin irritation (for example, reconstituted human skin methods, and human and animal skin organ culture methods) were under development and evaluation, a test protocol, preliminary prediction model and supporting data on different types of chemicals were only available for a method employing EpiDerm TM. Thus, it is proposed that this EpiDerm TM test undergoes prevalidation during1998. 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 set to anyone interested in taking part. This involves submitting data on 10 test chemicals to ECVAM, obtained according to a standard protocol with a preliminary prediction model, for review.

BOTHAM Philip A.;  EARL Lesley;  FENTEM Julia Helen;  ROGUET Roland;  VAN DE SANDT Johannes; 

1998-09-16

JRC16647