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Evaluation of In Vitro Cytotoxicity Test Methods
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Guidance Document

Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity

Based on Recommendations from 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)

NIH Publication No: 01-4500
August 2001

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Table of Contents

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

  1. Introduction
    1. Purpose and Scope of this Guidance Document
    2. The Correlation Between Basal Cytotoxicity and Acute Lethality
    3. In Vitro Determination of Starting Dose for In Vivo Tests
    4. Determination of In Vitro Test Performance Characteristics

  2. Elements of A Standard Test For Basal Cytotoxicity
    1. Selection of Cell Lines / Cells
    2. Recommended Measurement Endpoints for Basal Cytotoxicity
    3. Recommendations for Cytotoxicity Test Protocols

  3. Procedure for Qualifying a Cytotoxicity Test for use with the Registry of Cytotoxicity Prediction Model
    1. Procedure to Determine Whether a Candidate Cytotoxicity Test Can Use the RC Prediction Model
    2. Recommended Reference Chemicals from the RC for Test Qualification
    3. Results Obtained with the Recommended Reference Chemicals in Two Standard Tests for Basal Cytotoxicity with Human and Rodent Cells

  4. Recommended Basal Cytotoxicity Tests: BALB/C 3T3 And Normal Human Keratinocyte (NHK) Neutral Red Uptake (NRU) Tests
    1. Validation Status of the 3T3 NRU Test
    2. Reliability of the 3T3 NRU Test
    3. Validation Status of the NHK NRU Test
    4. Reliability of the NHK NRU Test

  5. Conclusion
    • Acknowledgement

  6. References
Appendices

A.   Registry Of Cytotoxicity

B.   List of Test Protocols for Basal Cytotoxicity, European Centre for the Validation Of Alternative Methods (ECVAM) Scientific Information System (SIS)

C.   Standard Operating Procedure (SOP) for the BALB/c 3T3 Neutral Red Uptake Cytotoxicity Test - A Test for Basal Cytotoxicity

  1. Standard Operating Procedure (SOP) for the BALB/c 3T3 Neutral Red Uptake Cytotoxicity Test - A Test for Basal Cytotoxicity
  2. Background and Introduction
  3. Rationale
  4. Basic Procedure
  5. Test Limitations
  6. Material
  7. Methods
  8. Data Analysis
  9. Prediction Model
  10. References

D.   Standard Operating Procedure (SOP) for the Normal Human Keratinocyte Neutral Red Uptake Cytotoxicity Test - A Test for Basal Cytotoxicity

  1. Background and Introduction
  2. Rationale
  3. Basic Procedure
  4. Test Limitations
  5. Material
  6. Methods
  7. Data Analysis
  8. Prediction Model
  9. References

E.   96-Well Plate Configuration

F.   Decimal Geometric Concentration Series

G.   Standard Test Reporting Template
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