The sda alternatives program: comparison ofIn VitroData with draize test data

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Abstract
Nine in vitro candidate test systems for estimating eye irritancy have been evaluated as potential replacements for the Draize test. They are a chorioallantoic membrane assay and a modification of it, a corneal plasminogen activator assay, the SIRC cytotoxicity assay, a uridine uptake assay, a cell protein accumulation assay, a Neutral Red assay, a chromium release assay and a Tetrahymena motility assay. The eye irritancy potentials of a number of cleaning products and ingredients as estimated from in vivo data were compared to in vitro results. For each test method, comparative data for a minimum of 11 and a maximum of 23 test materials have been obtained in Phases 1 and 2 of this study. The alkalinity of the test materials ranged from 0 to 2 meq HCl/g, encompassing the range for most cleaning products. The future possibility of utilizing alkalinity data and the results of an in vitro test method for classifying the irritancy of materials is suggested. Defining such an algorithm, one that would classify a material as an irritant or non-irritant, and the error associated with a classification decision based on this approach, remains to be done. Data on reproducibility of the in vitro test methods were obtained. Relative standard errors of the estimates reported for each method ranged from 14 to 33 percent.