PREDICTION OF OCULAR IRRITANCY OF FULL-STRENGTH CLEANERS AND STRIPPERS BY TISSUE-EQUIVALENT AND BOVINE CORNEAL ASSAYS

The Tissue Equivalent Assay (TEA) utilizing Skin(2) (model ZK 1200) an d Bovine Corneal Opacity and Permeability assay (BCOP) were evaluated for their ability to predict the eye irritation potential of 20 full-s trength industrial and household cleaning formulations. All products e valuated in this study had previously been tested for eye irritation i n vivo using a modified (30 mu l) or the standard (100 mu l) Draize as say protocol. Significant correlations with Draize data were observed when comparisons were made with MTT reduction in the TEA and with BCOP Total Score. No significant correlation with Draize Maximum Average S core (MAS) was observed when lactate dehydrogenase (LDH) or prostaglan din E(2) (PGE(2)) release was used as endpoint in the TEA. Correlation of TEA (MTT) scores with BCOP total scores yielded an r value of 0.84 . The results from this study suggest that strong formulations such as some floor strippers and metal cleaners may be distinguished from mil der formulations such as some neutral floor cleaners using either the TEA or BCOP assay. The strong industrial cleaners evaluated were extre mely cytotoxic: MTT t(50) values were < 1 min. BCOP total scores for t hese products also indicated severe irritancy. The complementarity not ed between these assays supports their use in tandem as a basis for pr oduct labeling decisions.