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

Jon Hamm, Kristie Sullivan, Amy J. Clippinger, Judy Strickland, Shannon Bell, Barun Bhhatarai, Bas Blaauboer, Warren Casey, David Dorman, Anna Forsby, Natàlia Garcia-Reyero, Sean Gehen, Rabea Graepel, Jon Hotchkiss, Anna Lowit, Joanna Matheson, Elissa Reaves, Louis Scarano, Catherine Sprankle, Jay TunkelDan Wilson, Menghang Xia, Hao Zhu, David Allen

Research output: Contribution to journalReview articlepeer-review

48 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)245-259
Number of pages15
JournalToxicology in Vitro
StatePublished - Jun 2017
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Toxicology


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