Comprehensive toxicity analysis of individual ENDS

The Contractor shall investigate the toxicity of 125 flavor ingredient chemicals alone and combined with metal using high throughput assays. The FDA will produce a final library of 125 flavor ingredient chemicals based on the predicted propensity of flavor ingredient chemicals to interact with metals. The Contractor shall perform cytotoxicity assays and measurements of cytokine levels in the supernatant to determine appropriate sublethal concentrations of flavor ingredient chemicals and metals to use in subsequent mutagenic and genotoxic assays, which consist of assays in cells lines and in bacteria. The Contractor shall determine based on measurables of the mutagenic and genotoxic experiments a list of 20 flavor ingredient chemicals and 20 flavor-metal combinations and their concentrations to be tested in the reconstructed human lung tissue model to measure the effects on metabolism, membrane integrity, cell viability, inflammation, and DNA damage. The Contractor shall perform all data analyses, provide FDA all of the raw data, and write study reports.