Alternative Approaches for Acute Inhalation Toxicity Testing to Address Global Regulatory and Non-regulatory Data Requirements

Co-hosted by the PETA International Science Consortium Ltd. and the US NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

Building upon a 2015 workshop on acute systemic toxicity testing (here), the Consortium and NICEATM co-hosted a meeting and webinar series to address current practices for acute inhalation toxicity testing, looking towards the development and implementation of approaches to reduce and replace acute inhalation testing in mammals for both global regulatory agencies and non-regulatory purposes.

September 22-23, 2016 meeting slides:

The case for an integrated approach to acute inhalation toxicity testing and assessment
Jon Hotchkiss, The Dow Chemical Company

An alternative framework for acute toxicity using mechanistic in silico and in vitro approaches
Dan Wilson, The Dow Chemical Company

An alternative approach for evaluating the human health risk from exposure to an irritant aerosol
Paul Hinderliter, Syngenta

Toxicokinetics in risk assessment: evaluation of in silico approaches
Michael Bartels,, LLC

Assessing bioavailability and systemic delivery of inhaled compounds: current status and future directions
Miyoung Yoon, Scitovation

US EPA OPP regulatory perspective on acute inhalation toxicity testing
Anna Lowit, US EPA Office of Pesticide Programs

US EPA OPPT regulatory perspective on acute inhalation toxicity testing
Iris Camacho, US EPA Office of Pollution Prevention and Toxics

ICCVAM’s vision and strategy for acute toxicity testing
Grace Patlewicz, US EPA

Webinar slides and recordings:

Tuesday, March 29, 2016
11am EDT
Current testing practices: regulatory requirements and non-regulatory testing Dr. Jon Hotchkiss, The Dow Chemical Company (slides)
Mr. Ian Indans, Health and Safety Executive, UK (slides)
Tuesday, April 26, 2016
11am EDT
State-of-the-science, practical application, and dosimetry considerations for in vitro and ex vivo methods Dr. Marianna Gaca, British American Tobacco (slides)
Dr. Annie Jarabek, US Environmental Protection Agency (NCEA, ORD) (slides)
Thursday, May 26, 2016
11am EDT
State-of-the-science and practical application of in silico methods Dr. Grace Patlewicz, US Environmental Protection Agency (NCCT, ORD) (slides)
Dr. Dan Wilson, The Dow Chemical Company
Tuesday, June 28, 2016
11am EDT
GHS additivity approach to classify mixtures based on ingredient toxicity Dr. Marco Corvaro, Dow Agrosciences (slides)
Tuesday, July 12,
11am EDT
Adverse outcome pathways Dr. Mathieu Vinken, Free University of Brussels-Belgium (slides)
Dr. Barbara Buckley, US Environmental Protection Agency (NCEA, ORD) (slides)
Thursday, September 8, 2016
11am EDT
21st century testing approaches


Dr. Dan Huh, University of Pennsylvania (slides)
Dr. Kelly BéruBé, Cardiff University (slides)

The meeting and webinar series steering committee was comprised of members from government and nongovernment stakeholder organizations including NICEATM, PETA International Science Consortium Ltd., The Dow Chemical Company, Dow AgroSciences, Simulations Plus, Inc., EURL ECVAM, the Netherlands Organisation for Applied Scientific Research, and the US Environmental Protection Agency.

As a prelude to this webinar series, we encourage you to watch an August 2015 webinar recorded for the workshop on “Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing”. This webinar summarizes the EPA OPP’s regulatory requirements for acute inhalation toxicology, and details two commercially available in vitro organotypic models.

Speakers at the August 19, 2015 webinar:
•John Redden (US EPA OPP), How the USEPA Pesticide Program Uses Inhalation Toxicity Studies
•Patrick Hayden (MatTek Corporation), Use of EpiAirwayTM Organotypic Human Airway Models and Assay Methods for In Vitro Inhalation Toxicology Screening
•Samuel Constant (Epithelix Sàrl), The Use of Human Airway Tissue-Based Assays (MucilAir™) for Acute Toxicity Assessment

Detailed information about the 2015 acute systemic toxicity workshop can be found here.