IRAG WORKING GROUP 5 - OTHER ASSAYS

As part of the Interagency Regulatory Alternatives Group (IRAG) progra m to evaluate the state of the art in the development of alternative ( non-whole animal) eye irritation tests, academic and industrial organi zations were invited to submit in vitro eye irritation data generated in their laboratories to one of several working groups for review. The assays reviewed in this report (from Working Group 5, ''Other Assays' ') were the EYTEX(TM) assay, tissue equivalent assay, a cytotoxicity a ssay using three-dimensional human fibroblast constructs, the Microtox (TM) assay, and other miscellaneous assays. Each submission consisted of raw data for chemicals and products tested, a description of the me thodology, and an analysis (generally by regression analysis and Pears on's correlation coefficient) for the performance of the in vitro test relative to its ability to predict individual ocular tissue scores or total ocular score. In vivo data were generated according to the scor ing methods proposed by Draize. Working Group 5 evaluated the submissi ons and commented on the utility of the assays. The variability of the in vivo data made conclusions difficult in many situations. Most of t hese assays were deemed useful (within limited chemical classes) for s creening purposes or for use in conjunction with other toxicological i nformation. (C) 1997 Published by Elsevier Science Ltd.