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In a June 2014 Federal Register (FR) notice (79 FR 35176), NICEATM (National Institute of Environmental Health Sciences) requested available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. Information submitted in response to the FR notice was included in the Technical Discussion on In Vitro Testing Strategies to Assess Inhalation Toxicity of Nanomaterials workshop, organized by NICEATM in cooperation with the PETA International Science Consortium, Ltd., (PISC) on Feb. 24-25, 2015. Attendees at this workshop defined specifications for development and evaluation of an in vitro system to assess inhalation toxicity of multiwalled carbon nanotubes. Recommendations were that the system should include a variety of lung cells co-cultured at an air-liquid interface and consideration of relevant human dosimetry and nanomaterial lifecycle transformations. These recommendations were central to a subsequent request for proposals issued by PISC to develop an appropriate testing system. In September 2015, PISC announced that they would fund groups at the University of Fribourg (Switzerland), Heriot-Watt University (United Kingdom), and MatTek Corporation (U.S.).
To determine the potential for high throughput screening data to reduce animal use for acute oral toxicity testing, NICEATM analyzed data from Tox21 and the EPA’s Toxicity Forecaster (ToxCast™) high throughput screening project for correlation and model fit to rat oral LD50 data. The goal of the analysis was to determine which tests or combinations of tests best characterized the rat oral toxicity data. The analysis, presented in a poster (Polk et al.) at the 2015 Society of Toxicology Annual Meeting, suggests that combinations of in vitro assays and data from small model organisms, such as zebrafish, offer promise for predicting outcomes of rat acute oral toxicity tests.
The workshop on Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing brought together representatives from regulatory agencies, academia, and industries to develop strategies for advancing alternative methods for product safety testing that meet the needs of regulatory agencies. Workshop attendees defined resources necessary to identify and implement alternatives to animal use, including high-quality reference data, training on use and interpretation of computational approaches, and global harmonization of testing requirements. Breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, with each group crafting a roadmap and strategy for accomplishing this within a three-year timeframe. NICEATM will coordinate creation of and provide support for a working group of workshop participants charged with implementing the strategies. Outcomes of the workshop will be summarized in a report to be submitted for publication in 2016.
NICEATM is participating on the Acute Toxicity Working Team of the European Partnership for Alternative Approaches to Animal Testing. This team is investigating methods and data analyses that could replace in vivo acute lethality testing for determining hazard classifications and labeling for new agrochemical and biocide active substances and industrial chemicals. These efforts are aimed at addressing the European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation requirements for acute toxicity lethality testing.