Xuefei Cao1, Jayme P. Coyle2, Rui Xiong1, Yiying Wang1, Robert H. Heflich1, Baiping Ren1, William M. Gwinn3, Patrick Hayden4, Liying Rojanasakul2
1 Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd., AR Jefferson, USA
2 Allergy and Clinical Immunology Branch, Health Effects Laboratory Division, National Institute for Occupational Safety and Health, Centers forDisease Control and Prevention,Morgantown,WV, USA
3 Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Durham, NC, USA
4 BioSurfaces Inc., Ashland, MA, USA
One important element for validating any new assay for making regulatory decisions is determining its performance relative to an accepted standard. Conducting in vivo inhalation toxicity studies using whole-body or nose-only exposure systems is expensive and time-consuming and typically requires a large number of animals. The goal of using alternative methods, like human in vitro ALI airway cultures, ultimately is to replace inhalation toxicity testing in animals with in vitro approaches. Transition from animal- to human-based models is ultimately expected to lead to faster and better predictive toxicity assessments and therapeutic development at lower cost. This study shows the development and validation of alternative in vitro methods for acute toxicity testing, including acute inhalation toxicity testing.