Alternative Methods for Acute Inhalation Toxicity
NICEATM and the PETA International Science Consortium (PISC) offered a webinar series from March to September 2016 on Alternative Approaches for Acute Inhalation Toxicity to Address Global Regulatory and Non-regulatory Data Requirements. Webinar presenters:
- Reviewed regulatory guidelines relevant to assessing inhalation toxicity hazard potential.
- Described alternative approaches for identifying substances likely to cause acute systemic toxicity through inhalation.
- Identified mechanisms of acute toxicity that may constitute key events in adverse outcome pathways for acute inhalation toxicity.
Following the webinar series, experts from industry, government, academia, and nongovernmental organizations met at NIH in September 2016 to discuss their experiences with alternative approaches for acute inhalation toxicity testing and to consider how to develop strategies that regulatory agencies will accept. Subgroups from the meeting were formed to address specific actions; these groups have been meeting as needed to continue progress toward implementation.
Summary of webinar series and workshop: Clippinger AJ, et al. Alternative approaches for acute inhalation toxicity testing to address global regulatory and non-regulatory data requirements: an international workshop report. Toxicol In Vitro. 2018;48:53-70.
In Vitro Testing Strategies to Assess Inhalation Toxicity of Nanomaterials
NICEATM is collaborating with PISC, EPA, and industry scientists to support a workgroup focused on inhalation toxicity. In 2014, NICEATM published a request for information (79 FR 35176, June 19, 2014) about devices and/or technologies currently used for identifying potential inhalation hazards.
Subsequently, the workgroup met in 2015 to define specifications for the development and evaluation of an in vitro system to assess the toxicity of multi-walled carbon nanotubes when inhaled. The workgroup determined that the proposed in vitro system should include different lung cells co-cultured at an air-liquid interface and consider relevant human dosimetry and nanomaterial lifecycle changes. Presentations from the meeting and a list of publications developed by meeting participants are available on the PISC website.
PISC used these recommendations in a request for proposals to develop an appropriate testing system; funding was awarded in September 2015.
Responses Received to the June 2014 Request for Information
- June Dunnick, National Institute of Environmental Health Sciences
- Sonia Grego, RTI International
- Tobias Krebs, VITROCELL Systems GmbH
- Samuel Constant, OncoTheis
- Patrick Hayden, MatTek Corporation
- Katherina Sewald, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
- David Warheit, DuPont Haskell Global Centers for Health and Environmental Sciences
- Ingeborg Kooter, TNO