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 ICCVAM and NICEATM

NIH Publication No: 01-4500
August 2001

Complete Document

Main Body


Appendix A: Registry Of Cytotoxicity 

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

Appendix C: Standard Operating Procedure (SOP) for the BALB/c 3T3 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

Appendix 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

Appendix E: 96-Well Plate Configuration 

Appendix F: Decimal Geometric Concentration Series 

Appendix G: Standard Test Reporting Template