Test Method Evaluation Report
ICCVAM 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
Download complete report (547 pages) [PDF]
Main Body Text
- Title Page [PDF]
- Table of Contents [PDF]
- List of Tables [PDF]
- Abbreviations and Acronyms [PDF]
- Interagency Coordinating Committee on the Validation of Alternative Methods: Agency Representatives
[PDF]
- Acknowledgements [PDF]
- Preface [PDF]
- Executive Summary [PDF]
- Section 1: Introduction [PDF]
- Section 2: ICCVAM Recommendations for the rLLNA Test Method [PDF]
- Section 3: Validation Status of the rLLNA Test Method [PDF]
- Section 4: ICCVAM Consideration of Public and SACATM Comments [PDF]
- Section 5: References [PDF]
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Appendix A: ICCVAM Evaluation of the Reduced Local Lymph Node Assay Method - Timeline
[PDF]
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
[PDF]
- 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
[PDF]
- Main Body
- Annex I: Summary of Study Results – CBA Mouse Database
Appendix D: Final Background Review Document: Reduced Murine Local Lymph Node Assay
[PDF]
- Title Page [PDF]
- Table of Contents [PDF]
- List of Tables [PDF]
- List of Figures [PDF]
- Abbreviations and Acronyms [PDF]
- Interagency Coordinating Committee on the Validation of Alternative Methods: Agency Representatives
[PDF]
- Acknowledgements [PDF]
- Preface [PDF]
- Executive Summary [PDF]
- Section 1: Introduction and Rationale for the Proposed Use of the Reduced
Murine Local Lymph Node Assay (rLLNA) to Identify Skin Sensitizers [PDF]
- Section 2: rLLNA Protocol Components [PDF]
- Section 3: Substances Used for Validation of the rLLNA [PDF]
- Section 4: Comparative In Vivo Reference Data - the Traditional LLNA [PDF]
- Section 5: rLLNA Test Method Data and Results [PDF]
- Section 6: Accuracy of the rLLNA [PDF]
- Section 7: Reliability of the rLLNA [PDF]
- Section 8: rLLNA Data Quality [PDF]
- Section 9: Other rLLNA Scientific Reports and Reviews [PDF]
- Section 10: Animal Welfare Considerations [PDF]
- Section 11: Practical Considerations [PDF]
- Section 12: References [PDF]
- Section 13: Glossary [PDF]
- Annex I: ECVAM Scientific Advisory Committee Statement on the Validity of the rLLNA [PDF]
- Annex II: Physicochemical Properties of Substances Evaluated in the rLLNA [PDF]
- Annex III: Traditional LLNA Data Used for the Performance Analysis of the rLLNA [PDF]
- Annex IV: Substances in the NICEATM LLNA Database for which an Initial
Dose of 10% or Greated Elicited a Negative Result but a Subsequent Higher Dose Elicited a Positive Response [PDF]
Appendix E: ESAC Statement on the Validity of the rLLNA
[PDF]
Appendix F: Independent Scientific Peer Review Panel Assessment
- F1: Independent Scientific Peer Review Panel Report: Validations 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 [PDF]
- F2: Summary Minutes from Peer Review Panel Meeting on March 4-6, 2008
[PDF]
Appendix G: Federal Register Notices and Public Comments
- G1: Federal Register Notices
- 1 - 72 FR 27815 (May 17, 2007): The Murine Local Lymph Node Assay: Request for Comments,
Nominations of Scientific Experts, and Submission of Data [PDF]
- 2 - 72 FR 52130 (September 12, 2007): Draft Performance Standards for the
Murine Local Lymph Node Assay: Request for Comments [PDF]
- 3 - 73 FR 1360 (January 8, 2008): Announcement of an Independent Scientific
Peer Review Panel Meeting on the Murine Local Lymph Node Assay; Availability of Draft
Background Review Documents; Request for Comments [PDF]
- 4 - 73 FR 29136 (May 20, 2008): Peer Review Panel Report on the Validation Status of
New Versions and Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method for
Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of
Availability and Request for Public Comments [PDF]
- G2 Public Comments Received in Response to Federal Register Notices
- G3 SACATM Comments: SACATM Meeting on June 18-19, 2008 [PDF]
Appendix H: Relevant Skin Sensitization Regulations and Testing Guidelines
- H1 Table of Relevant Skin Sensitization Test Regulations [PDF]
- H2 OECD Guideline 429: Skin Sensitisation – Local Lymph Node Assay
[PDF]
- H3 OECD Guideline 406: Skin Sensitisation
[PDF]
- H4 Health Effects Test Guidelines OPPTS 870.2600: Skin Sensitization
[PDF]
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