In the US and Europe guidelines exist for evaluation and validation of new alternative test methods. These guidelines have been used as a framework for the assessment of novel methods which offer benefits in the context of the requirement for experimental animals with respect to Replacement, Reduction and/or Refinement. The objective of this Workshop is to use examples, primarily from the discipline of Immunotoxicology, to consider the strategies necessary to gain acceptance of novel test methods by regulatory authorities and to bring to the attention of the toxicology community the issues that need to be addressed in assay evaluation and validation. The current guidelines used for consideration of alternative methods will be reviewed with particular emphasis on those developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). As a classic illustration of a validation exercise, the evaluation of a novel phototoxicity method, the 3T3 Neutral Red Uptake Phototoxicity Assay, will be discussed. In addition, a rather different approach used for the assessment of the local lymph node assay, a method for the identification of contact allergens, will be described and the current validation status of this method discussed. Finally, the validation needs of the methods currently available for the identification of potential immunotoxicants will be considered in the context of new and emerging regulatory requirements. The main goal of this workshop is to stimulate discussion between those who are applying modem science to the development of novel approaches to toxicity testing and those charged with evaluating those new methods to ensure the level and consistency of performance necessary for regulatory acceptance.
The Toxicologist. Society of Toxicology 38th Annual Meeting, March 14-18, 1999, New Orleans, Louisiana