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Evaluation of the Ability of Standard Genetic Toxicology Assays to Assess the Relative Genotoxic Potential of Cigarette Smoke Condensates

Principal Investigator: Martha M. Moore / Patricia Richter

Funding Mechanism: JV

ID number: E0745901

Award Date: 8/18/2011

Institution: National Center for Toxicological Research


Genetic toxicology tests are used as part of hazard identification for a variety of FDA-regulated products. This study will evaluate recommended in vitro assays to determine if they can be used to assist the Center for Tobacco Products (CTP) in making science-based regulatory decisions related to tobacco product toxicity. These assays include a gene mutation assay in bacteria (i.e., Ames test or E. coli) and an in vitro mammalian cell assay capable of detecting chromosomal damage (i.e., mouse lymphoma Tk assay, in vitro micronucleus assay or gross chromosomal aberration analysis). Study aims are: (1) to determine if genetic toxicology assays or a combination of assays provide an adequate potency range to detect reductions of selected harmful and potentially harmful constituents (HPHCs) in tobacco products in varying amounts; and (2) to evaluate, develop and validate quantitative assays to detect statistically significant differences in cigarette cytotoxicity over a range of biologically-relevant concentrations. This study may establish whether standard genetic toxicology assays are capable of assessing the genotoxic potential of cigarette smoke solutions and aerosolized smoke. Suitable assays will provide data to allow potential comparisons of current and new tobacco products.