National Toxicology Program

Workshop Report and Test Method Recommendations

Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity:

Results of an International Workshop Organized by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

Download Adobe Acrobat Reader

View complete report (2.5 MB)

Please note:

• Large files may take some time to download: times will vary based on the speed of the online connection.
• The files containing the complete volumes may not be fully accessible to some readers. If you have difficulty accessing this document, please send an email to the ICCVAM Webmaster [Send Email] or call NICEATM at 919-316-4729. The files linked below may provide improved accessibility.

Table of Contents

• ICCVAM and NICEATM Overview
• Table of Contents
• List of Tables
• List of Figures
• List of Acronyms/Abbreviations
• Workshop Breakout Groups
• Acknowledgements
• Preface
• Executive Summary

1. Introduction
   1. History and Purpose of Acute Toxicity Testing
   2. Purpose and Objectives of the Workshop
   3. Conduct of the Workshop


2. In Vitro Screening Methods for Assessing Acute Toxicity
   1. Introduction
   2. Background
   3. Identifying Needs
   4. Current Status
   5. Future Directions
   6. Summary
   7. Recommendations
   8. References - Addendum


3. In Vitro Methods for Assessing Acute Toxicity: Biokinetic Determinations
   1. Introduction
   2. Identifying Needs
   3. Current Status
   4. Future Directions
   5. Recommendations
   6. References


4. In Vitro Methods for Organ-Specific Toxicity
   1. Introduction
   2. Review of a Proposed Screen to Elucidate Mechanism of Injury
   3. In Vitro Methods for Determination of Acute Liver Toxicity
   4. In Vitro Methods for the Determination of Acute Central Nervous System (CNS) Toxicity
   5. In Vitro Methods to Assess Blood-Brain Barrier (BBB) Function
   6. In Vitro Systems to Study Kidney Toxicity
   7. In Vitro Methods to Assess Cardiotoxicity
   8. In Vitro Methods to Study Hematopoietic Toxicity
   9. In Vitro Methods to Study Respiratory System Toxicity
   10. Conclusions on the Use of In Vitro Systems for Assessing Organ-Specific Effects of Acute Exposure
   11. References


5. Chemical Data Sets for Validation of In Vitro Acute Toxicity Test Methods
   1. Introduction
   2. Objectives
   3. Current Status: Discussions Regarding the Use of NTP and HPV Databases and the Use of QSAR
   4. Identification of Needs
   5. Conclusions
   6. Recommended Actions


6. Glossary


7. Registry of Cytotoxicity Data (ZEBET)
   1. The ZEBET Database
   2. Data from 347 Chemicals for the Calculation of the Regression Between Cytotoxicity and Acute Oral Systemic Toxicity


8. References

Appendices

A.   Workshop Agenda

B.   Summary Minutes and Public Comments (Plenary Sessions)

C.   Guidance for Breakout Groups

D.   Background Document for Workshop Participants

1. Preface
2. Introduction
3. In Vitro Test Methods for Predicting In Vivo Toxicity - General Strategies
4. In Vitro Screening Methods for Assessing Acute Toxicity (Breakout Group 1)
5. In Vitro Methods for Assessing Acute Toxicity - Toxicokinetic Determination
   (Breakout Group 2)
6. In Vitro Methods for Assessing Acute Toxicity - Specific Organ Toxicity and Mechanism
   (Breakout Group 3)
7. Chemical Data Sets for Validation of In Vitro Toxicity Tests (Breakout Group 4)
8. Relevant General Databases
9. References
10. Glossary

E.   NICEATM Summary of The Multicenter Evaluation of In Vitro Cytotoxicity (MEIC)

F.   Federal Regulations on Acute Toxicity

1. U.S. EPA Classification and Labeling Regulations
2. CPSC Regulations
3. U.S. Department of Transportation
1. Regulations
2. Materials Assigned as Division 6.1 Materials
4. OSHA Regulations

G.   Workshop Participants

H.   Federal Register Notices About the In Vitro Workshop

1. 65 FR 37400 - Notice of an International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity; Request for Data and Suggested Expert Scientists (June 14, 2000)
2. 65 FR 57203 - Notice of an International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity: Workshop Agenda and Registration Information (September 21, 2000)

I.   ICCVAM Test Method Recommendations