ToXchange In Vitro Approaches to Assess the Toxicity of Inhaled Substances
SOT Virtual CE Course: PM13
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Chair(s): Amy Clippinger, PETA International Science Consortium Ltd., United Kingdom; and Emily Reinke, Army Public Health Center.
Primary Endorser:
In Vitro and Alternative Methods Specialty Section
Other Endorser(s):
Inhalation and Respiratory Specialty Section; Regulatory and Safety Evaluation Specialty Section
Inhalation is a major route of human exposure to airborne substances, and as such, there are regulatory and nonregulatory needs to assess the potential toxicity of inhaled substances. While the standard regulatory requirement is a rat inhalation toxicity test, anatomical and physiological differences between rodents and humans have led to substantial investment in the optimization of alternative approaches. These alternative approaches can be based on human mechanisms of toxicity, thus better protecting human health while reducing animal use. In this course, speakers from government, contract research organizations, academia, and NGOs, as well as method developers, will discuss progress and challenges associated with various approaches for inhalation toxicity testing. It will include an introductory overview, setting the stage for the remaining talks by discussing the currently used rat inhalation tests and how an alternative approach can be demonstrated to be a valid replacement. Other topics to be covered will be the use of cell culture systems, 3D reconstructed human tissue models, and human precision-cut lung slices, as well as the use of in vitro exposure devices for deposition of test chemicals. The final speaker will present a regulatory perspective on processes in place that allow for acceptance of alternative approaches for inhalation toxicity testing, highlighting a successful example. These presentations will explore the value of the air-liquid interface (ALI) for testing, advantages and limitations of different approaches, and case studies of the use of different model systems in both nonregulatory and regulatory paradigms. Overall, a course attendee should learn about the state-of-the-science of in vitro approaches for respiratory toxicity testing and gain insight into determining which method is most appropriate, depending on the test substance and purpose of the study. This course is aimed at scientists at all levels from industry, government, and academia.
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An Introduction to New Approach Methodologies (NAMs) and Understanding Their Potential to Support Regulatory Decisions
Regulatory Landscape and Key Considerations for Establishing Inhalation Reference Data.—David Allen, Integrated Laboratory Systems Inc., Research Triangle Park, NC.
Current Status of In Vitro Models to Evaluate Pulmonary Toxicity.—Arno Gutleb, Luxembourg Institute of Science and Technology, Esch-sur-Alzette, Luxembourg.
3D In Vitro and Ex Vivo Pulmonary Test Systems Provide Human-Relevant Toxicity Data.—Holger Behrsing, Institute for In Vitro Sciences Inc., Gaithersburg, MD.
Regulatory Use of Nonanimal Approaches for Assessing Inhalation Toxicity of Pesticides.—Monique Perron, US EPA/OPP, Washington, DC.
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