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Comput Toxicol. 2018 Nov;8(11):21-24. doi: 10.1016/j.comtox.2018.08.002.

Predictive Models for Acute Oral Systemic Toxicity: A Workshop to Bridge the Gap from Research to Regulation.

Author information

1
National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.
2
Integrated Laboratory Systems, Inc., Research Triangle Park, North Carolina 27560, United States.
3
National Center for Computational Toxicology (NCCT), Office of Research and Development, US Environmental Protection Agency, 109 TW Alexander Dr, Research Triangle Park (RTP), NC 27711, USA.

Abstract

In early 2018, the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) published the "Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States" (ICCVAM 2018). Cross-agency federal workgroups have been established to implement this roadmap for various toxicological testing endpoints, with an initial focus on acute toxicity testing. The ICCVAM acute toxicity workgroup (ATWG) helped organize a global collaboration to build predictive in silico models for acute oral systemic toxicity, based on a large dataset of rodent studies and targeted towards regulatory needs identified across federal agencies. Thirty-two international groups across government, industry, and academia participated in the project, culminating in a workshop in April 2018 held at the National Institutes of Health (NIH). At the workshop, computational modelers and regulatory decision makers met to discuss the feasibility of using predictive model outputs for regulatory use in lieu of acute oral systemic toxicity testing. The models were combined to yield consensus predictions which demonstrated excellent performance when compared to the animal data, and workshop outcomes and follow-up activities to make these tools available and put them into practice are discussed here.

KEYWORDS:

ICCVAM; QSAR; acute oral toxicity; read-across; workshop

PMID:
30320239
PMCID:
PMC6178952
[Available on 2019-11-01]
DOI:
10.1016/j.comtox.2018.08.002

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