Test Method Evaluation Report: Reduced LLNA

Document Cover: ICCVAM Test Method Evaluation ReportICCVAM Test Method Evaluation Report
The Reduced Murine Local Lymph Node Assay: An Alternative Test Method
Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products

NIH Publication No. 09-6439
Complete report (547 pages, 11.2 Mb)
(Note: Large files may take some time to download: times will vary based on the speed of the online connection)


Main Body Text

Appendix A: ICCVAM Evaluation of the Reduced Local Lymph Node Assay Method - Timeline

Appendix B: ICCVAM-Recommended Test Method Protocol (Updated 2008): 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

Appendix C: Evaluating the Impact of Reducing the Sample Size from Five to Four Animals per Group on the Performance of the Ratio Rule of SI > 3 in LLNA Testing

  • Main Body
  • Annex I: Summary of Study Results – CBA Mouse Database

Appendix D: Final Background Review Document: Reduced Murine Local Lymph Node Assay

Note: 15.7 Mb file — may take a few moments to to download

Appendix E: ESAC Statement on the Validity of the rLLNA

Appendix F: Independent Scientific Peer Review Panel Assessment

Appendix G: Federal Register Notices and Public Comments

Appendix H: Relevant Skin Sensitization Regulations and Testing Guidelines