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| Peer Review Panel | Presentations | Recommendations and Agency Responses |
| Test Method Evaluation Report |
Test Method Evaluation Report
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ICCVAM Test Method Evaluation Report (TMER):
In Vitro Cytotoxicity Test Methods for Estimating Starting Doses For Acute
Oral Systemic Toxicity Testing November 2006 - NIH Publication No. 07-4519 Main Body Text [PDF] Appendix A: Peer Review Panel Reports [PDF] Appendix B: Relevant Federal Acute Oral Toxicity Regulations and Testing Guidelines [PDF] Appendix C: Recommended Test Method Protocols [PDF] Appendix D: Federal Register Notices and Public Comments [PDF] Appendix E: ICCVAM Recommendations from the 2000 International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity [PDF] Get Adobe Acrobat Reader |
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Table of Contents
List of Tables
List of Abbreviations and Acronyms
Interagency Coordinating Committee on the Validation of Alternative Methods - Designated Agency Representatives
Acknowledgments
Preface
Executive Summary
- INTRODUCTION
- Evaluation of the Use of In Vitro Cytotoxicity Test Methods to Estimate Acute Oral Toxicity
- Evaluation of the Use of In Vitro Cytotoxicity Test Methods to Estimate Starting Doses for Acute Oral Toxicity Tests
- Peer Review of the NICEATM/ECVAM Validation Study
- Report Organization
- ICCVAM RECOMMENDATIONS FOR IN VITRO NEUTRAL RED UPTAKE (NRU) BASAL CYTOTOXICITY TEST METHODS
- Test Method Description
- Reference Substances
- Test Method Accuracy
- Test Method Reliability (Inter- and Intra-Laboratory Reproducibility)
- Animal Welfare Considerations: Reduction, Refinement, and Replacement
- ICCVAM Recommendations for Test Method Uses
- ICCVAM Recommendations for Future Studies
- ICCVAM RECOMMENDED PERFORMANCE STANDARDS
- Essential Test Method Components for In Vitro Basal Cytotoxicity Assays to Predict Starting Dose for Acute Oral Toxicity Tests
- Reference Substances for In Vitro Basal Cytotoxicity Assays to Predict Starting Doses for Acute Oral Toxicity Tests
- Accuracy and Reliability Standards
- REFERENCES
APPENDICES:
APPENDIX A - PEER REVIEW PANEL REPORTS
- Peer Review Panel Report: The Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing
- Summary Minutes from Peer Review Panel Meeting on May 23, 2006
APPENDIX B - RELEVANT FEDERAL ACUTE ORAL TOXICITY REGULATIONS AND TESTING GUIDELINES
- Table of Relevant Acute Oral Toxicity Regulations
- OECD Guideline 425: Acute Oral Toxicity ñ Up-and-Down Procedure
- OECD Guideline 423: Acute Oral Toxicity ñ Acute Toxic Class Method
- OECD Guideline 420: Acute Oral Toxicity ñ Fixed Dose Procedure
- Health Effects Test Guidelines OPPTS 870.1100: Acute Oral Toxicity
- OECD Series on Testing and Assessment Number 24: Guidance Document on Oral Toxicity Testing
APPENDIX C - RECOMMENDED TEST METHOD PROTOCOLS
- Test Method Protocol for the BALB/c 3T3 NRU Cytotoxicity Test Method
- Test Method Protocol for the NHK NRU Cytotoxicity Test Method
APPENDIX D - FEDERAL REGISTER NOTICES AND PUBLIC COMMENTS
- Federal Register Notices
- Federal Register Notice (65 FR 37400, June 14, 2000): Notice of an International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity, co-sponsored by NIEHS, NTP and the U.S. Environmental Protection Agency (EPA): Request for Data and Suggested Expert Scientists
- Federal Register Notice (65 FR 57203, September 21, 2000): Notice of an International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity
- Federal Register Notice (66 FR 49686, September 28, 2001): Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity; Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity: Notice of Availability and Request for Public Comment
- Federal Register Notice (69 FR 11448, March 10, 2004): Notice of the Availability of Agency Responses to ICCVAM Test Recommendations for the Revised Up-and-Down Procedure for Determining Acute Oral Toxicity and In Vitro Methods for Assessing Acute Systemic Toxicity
- Federal Register Notice (69 FR 61504, October 19, 2004): Availability of Updated Standardized In Vitro Cytotoxicity Test Method Protocols for Estimating Acute Oral Systemic Toxicity; Request for Existing In Vivo and In Vitro Acute Toxicity Data
- Federal Register Notice (70 FR 14473, March 22, 2005): Request for Nominations for an Independent Peer Review Panel To Evaluate In Vitro Testing Methods for Estimating Acute Oral Systemic Toxicity and Request for In Vivo and In Vitro Data
- Federal Register Notice (71 FR 14229, March 21, 2006): Announcement of a Peer Review Meeting on the Use of In Vitro Testing Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Tests
- Federal Register Notice (71 FR 39122, July 11, 2006): Availability of the Peer Review Panel Report on the Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing
- ICCVAM Consideration of Public Comments Received in Response to Federal Register Notices
APPENDIX E - ICCVAM RECOMMENDATIONS FROM THE 2000 INTERNATIONAL WORKSHOP ON IN VITRO METHODS FOR ASSESSING ACUTE SYSTEMIC TOXICITY
