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Toxicol In Vitro. 2017 Jun;41:245-259. doi: 10.1016/j.tiv.2017.01.004. Epub 2017 Jan 6.

Alternative approaches for identifying acute systemic toxicity: Moving from research to regulatory testing.

Author information

1
Integrated Laboratory Systems, Inc., Research Triangle Park, NC, USA. Electronic address: hammjt@niehs.nih.gov.
2
Physicians Committee for Responsible Medicine, 5100 Wisconsin Ave NW, Ste 400, Washington, DC, USA.
3
PETA International Science Consortium Ltd., London, UK.
4
Integrated Laboratory Systems, Inc., Research Triangle Park, NC, USA.
5
The Dow Chemical Company, Midland, MI, USA.
6
Institute for Risk Assessment Sciences, Division of Toxicology, Utrecht University, Utrecht, Netherlands.
7
NTP Interagency Center for the Evaluation of Alternative Toxicological Methods, Research Triangle Park, NC, USA.
8
North Carolina State University, Raleigh, NC, USA.
9
Stockholm University and Swedish Toxicology Sciences Research Center (Swetox), Södertälje, Sweden.
10
US Army Engineer Research and Development Center, Alexandria, VA, USA.
11
Dow AgroSciences, Indianapolis, IN, USA.
12
European Union Reference Laboratory for Alternatives to Animal Testing, Ispra, Italy.
13
U.S. Environmental Protection Agency, Office of Pesticide Programs, Washington, DC, USA.
14
U.S. Consumer Product Safety Commission, Washington, DC, USA.
15
U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, DC, USA.
16
SRC, Inc., Syracuse, NY, USA.
17
National Center for Advancing Translational Sciences, Rockville, MD, USA.
18
Department of Chemistry(,) Rutgers University-Camden, Camden, NJ, USA.

Abstract

Acute systemic toxicity testing provides the basis for hazard labeling and risk management of chemicals. A number of international efforts have been directed at identifying non-animal alternatives for in vivo acute systemic toxicity tests. A September 2015 workshop, Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing, reviewed the state-of-the-science of non-animal alternatives for this testing and explored ways to facilitate implementation of alternatives. Workshop attendees included representatives from international regulatory agencies, academia, nongovernmental organizations, and industry. Resources identified as necessary for meaningful progress in implementing alternatives included compiling and making available high-quality reference data, training on use and interpretation of in vitro and in silico approaches, and global harmonization of testing requirements. Attendees particularly noted the need to characterize variability in reference data to evaluate new approaches. They also noted the importance of understanding the mechanisms of acute toxicity, which could be facilitated by the development of adverse outcome pathways. Workshop breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, with each group crafting a roadmap and strategy to accomplish near-term progress. The workshop steering committee has organized efforts to implement the recommendations of the workshop participants.

KEYWORDS:

3Rs; Acute systemic toxicity; Alternatives; Dermal; In silico; In vitro; Inhalation; LD(50); Oral

PMID:
28069485
PMCID:
PMC5479748
DOI:
10.1016/j.tiv.2017.01.004
[Indexed for MEDLINE]
Free PMC Article

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