National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/acutetox-wksp

Workshop on Acute Chemical Safety Testing


Acute Toxicity Workshop PosterScientific Workshop on Acute Chemical Safety Testing:
Advancing
In Vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations

February 6-7, 2008
Natcher Conference Center - National Institutes of Health
Bethesda, MD

Workshop Documents

Workshop Overview

The goals of this workshop were to:

  1. Review the state-of-the-science and identify knowledge gaps (at the whole organism, organ system, cellular, and/or molecular levels) regarding the key in vivo pathways involved in acute systemic toxicity
  2. Recommend how these knowledge gaps can be addressed by collecting mechanistic biomarker data during currently required in vivo safety testing
  3. Recommend how in vivo key pathway information can be used to develop more predictive mechanism-based in vitro test systems and to identify biomarkers that may serve as earlier, more humane endpoints for in vivo test methods
  4. Recommend how mechanism-based in vitro test systems and earlier, more humane endpoints can be used to further reduce, refine, and eventually replace animal use for acute systemic toxicity testing while ensuring the protection of human and animal health

Over 100 attendees from five countries represented various ICCVAM stakeholder groups, including Federal agencies, academia, industry, international organizations, and the animal welfare community. Attendees participated in breakout group discussions to address goals, objectives, and questions put forth by the workshop sponsors relating to the following key themes:

  1. Key Pathways for Acute Systemic Toxicity
  2. Current Acute Systemic Toxicity Injury and Toxicity Assessments
  3. Identifying Earlier Humane Endpoints for Acute Systemic Toxicity Testing
  4. Application of In Vivo Mode of Action and Mechanistic Information to the Development and Validation of In Vitro Methods for Assessing Acute Systemic Toxicity
  5. Industry Involvement in Test Method Development, Validation, and Use

Five breakout groups explored key themes related to the goals. Each breakout group drafted recommendations for future activities to address research and development needs in the key theme areas. The recommendations are detailed in the workshop report below.

This workshop was organized by NICEATM and sponsored by ICCVAM, NICEATM, the European Centre for the Validation of Alternative Methods (ECVAM) and the Japanese Center for the Validation of Alternative Methods (JaCVAM).

Workshop Report

Main Body 
Appendix A: Workshop Agenda 
Appendix B: Breakout Group Objectives and Questions 
Appendix C: Federal Register Notices
  • C1: 73 FR 493 (January 3, 2008): Workshop on Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations
Appendix D: Acute Oral Toxicity Test Guidelines
Appendix E: Registered Participants 
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.