This proposal describes a SBIR project designed to determine the feasibility of employing a human keratinocyte cell culture in an in vitro test system capable of determining the cutaneous toxicity of an environmental chemical. Specific project aims include the study of macromolecular cellular events to measure the degree of variability of primary epidermal cultures related to the use of cultivated keratinocytes isolated from tissue obtained from different donors and the selection of appropriate solvents for use in the topical application of test chemicals to the surface of the epidermal culture. Specific enzyme leakage from damaged cells will be measured biochemically to determine the severity of the irritation. This project and its Phase II successor have great potential to provide toxicologists with a fast, accurate, reliable and objective end point assay with which to screen chemicals for potential cutaneous toxicity. Sold in kit form and containing all the components of a complete test system, an in vitro procedure based on this project will have global sales potential.
