THE SDA ALTERNATIVES PROGRAM PHASE-III - COMPARISON OF IN-VITRO DATA WITH ANIMAL EYE IRRITATION DATA ON SOLVENTS, SURFACTANTS, OXIDIZING-AGENTS, AND PROTOTYPE CLEANING PRODUCTS

Nine in vitro candidate tests for estimating eye irritation potential were evaluated as potential replacements for the Draize test. The test s examined were a cell protein assay, the chorioallantoic membrane vas cularization assay, a cell protein assay, a fibroblast cytotoxicity as say, the Living Dermal Model and Living Skin Equivalent, two neutral r ed assays, an SIRC cytotoxicity assay, and a Tetrahymena thermophila m otility assay. The results from these in vitro tests were compared to results from a modified Draize test with 22 test materials. The test m aterials were selected to represent various classes of cleaning produc ts and ingredients. Ingredients were tested at concentrations represen tative of concentrations typically found in cleaning products. The cor relation coefficients with all test materials considered ranged from 0 .58 to 0.91. When only nonalkaline materials are considered, the corre lation coefficients of all 10 tests were not significantly different f rom one another, ranging from 0.8 to 0.9. The assays least affected by the alkalinity of the test substances were the corneal epithelial pla sminogen activator assay, the chorioallantoic membrane vascular assay, and the Tetrahymena motility assay. Further, six of the 10 tests were able to identify the five nonirritants in the study, although the rel ative irritation potentials of the irritants were not accurately predi cted by any of the tests. Results from a low-volume eye irritation tes t (LVET) were also compared to results from a modified Draize test wit h the same 22 test materials. The LVET had a high correlation with the modified Draize test and will be useful for future comparison with ot her alternative eye irritation tests. Based on these data, a number of alternative tests developed to replace the Draize eye irritation test included in this phase of research are useful for screening the eye i rritation potential of nonalkaline cleaning products, although some te sts are better for identifying the eye irritation potential of test ma terials with alkaline or oxidation potential. Although the ability of the eye to recover from damage was not measured by any test, the tests show promise for the use of determining eye irritation potential.