National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/40516

Test Method Evaluation Report: Use of the LLNA for Potency Categorization

Cover of the ICCVAM LLNA Potency Test Method Evaluation ReportICCVAM Test Method Evaluation Report
Usefulness and Limitations of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans

NIH Publication No. 11-7709
Complete report (9 MB)

Please note:

  • Large files may take some time to download: times will vary based on the speed of the online connection.
  • The file containing the complete document 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.

View Test Method Evaluation Report by Section

Front Matter and Main Body
Includes Table of Contents, Lists of Tables and Figures, List of Abbreviations and Acronyms, Acknowledgements, Preface, Executive Summary

Main Body sections:

  • Section 1: Introduction
  • Section 2: ICCVAM Recommendations: Usefulness and Limitations of the LLNA for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans, Test Method Protocol, and Future Studies
  • Section 3: Validation Status for Use of the LLNA to Determine Skin Sensitization Potency Categories
  • Section 4: ICCVAM Consideration of Independent Peer Review Panel Report and Other Comments

Appendix A: Timeline for ICCVAM Evaluation on Usefulness and Limitations of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans

Appendix B: Updated ICCVAM-Recommended Protocol: The Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products

  • Main Body
  • Annex I: An Approach to Dissection and Identification of the Draining (“Auricular”) Lymph Nodes
  • Annex II: An Example of How to Reduce the Number of Animals in the Concurrent Positive Control Group of the Local Lymph Node Assay
  • Annex III: Evaluating Local Irritation and Systemic Toxicity in the Local Lymph Node Assay
  • Annex IV: Procedures for Calculating the Estimated Concentration of a Substance Expected to Produce a Stimulation Index of 3 (EC3) in the Murine Local Lymph Node Assay

Appendix C: Final Background Review Document: Use of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans

Appendix D: Independent Scientific Peer Review Panel Assessment
  • Appendix D1: Summary Minutes from Peer Review Panel Meeting on March 4-6, 2008
  • Appendix D2: Independent Scientific Peer Review Panel Report: Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products
Appendix E: GHS Materials on Skin Sensitization Potency
  • Appendix E1: Meetings of the Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals Relevant to Subcategorization of Skin Sensitizers
  • Appendix E2: ST/SG/AC.10/C.4.2006/16, Strong versus Weak Sensitizers
  • Appendix E3: UN/SCEGHS/12/INF.16 (OECD), Progress Report on OECD Work Since the Last Sub-Committee Meeting
  • Appendix E4: UN/SCEGHS/15/INF.14 (OECD), Proposal for Revising Chapter 3.4 with Respect to Strong versus Weak Sensitizers: Explanatory Notes and Revised Chapter with Visible Changes
  • Appendix E5: ST/SG/AC.10/C.4/2008/18 (Secretariat), Revision of Chapter 3.4 with Respect to Strong versus Weak Sensitizers
  • Appendix E6: ST/SG/AC.10/C.4/2008/18/Add.1 (Secretariat), Revision of Chapter 3.4 with Respect to Strong versus Weak Sensitizers, Addendum
  • Appendix E7: UN/SCEGHS/16/INF.3 (Secretariat), Section 3.4.2 of Chapter 3.4
Appendix F: Federal Register Notices and Public Comments

Appendix G: Relevant Skin Sensitization Regulations and Testing Guidelines

  • Appendix G1: Table of Relevant Skin Sensitization Test Regulations
  • Appendix G2: Health Effects Test Guidelines OPPTS 870.2600: Skin Sensitization
  • Appendix G3: ISO 10993-10: Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Delayed-type Hypersensitivity
    Available for purchase on the ISO website
  • Appendix G4: OECD Guideline 429: Skin Sensitisation – Local Lymph Node Assay
  • Appendix G5: OECD Guideline 406: Skin Sensitisation
The NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.