Peer Review Panel Meeting
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NICEATM and ICCVAM convened an independent scientific peer review panel meeting on April 28-29, 2009,
to evaluate three non-radioactive modified versions and new applications for the Murine Local Lymph Node Assay.
The Panel peer reviewed the draft review documents for each topic and evaluated the extent
that established validation and acceptance criteria have been appropriately addressed. The Panel
also commented on the extent that the review documents support draft ICCVAM recommendations on
proposed test method protocols and uses. The Panel's conclusions and recommendations will be
published in the Panel's report, which will be available on this page in June.
See below for draft documents reviewed by the Panel
View agenda for the Panel meeting [PDF]
View information about the 2008 LLNA Peer Panel Meeting
Announcement of a Second Meeting of the Independent Scientific Peer Review Panel on the Murine
Local Lymph Node Assay; Availability of Draft Background Review Documents (BRD); Request for Comments
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View Federal Register Notice
(Vol. 74, No. 38, pages 8974-8975, February 27, 2009) [PDF] |
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Documents to be Reviewed by the LLNA Peer Review Panel
Non-radioactive Murine Local Lymph Node Assay Protocols
BrdU-ELISA Test Method
- Draft Background Review Document
View Background Review Document with all appendices (201 pages) [PDF]
- Main Body (91 pages) [PDF]
- Appendix A: LLNA: BrdU-ELISA Protocol (10 pages) [PDF]
- Appendix B: Physico-Chemical Properties of Substances Tested Using the LLNA: BrdU-ELISA (10 pages) [PDF]
- Appendix C: Comparative LLNA: BrdU-ELISA, Traditional LLNA,
Guinea Pig, and Human Skin Sensitization Data (28 pages) [PDF]
- Appendix D: Individual Animal Data for the LLNA: BrdU-ELISA (32 pages) [PDF]
- Appendix E: Reproducibility Analyses for LLNA: BrdU-ELISA with Decision Criterion of SI ≥ 1.5 (16 pages) [PDF]
- Appendix F: Reproducibility Analyses for LLNA: BrdU-ELISA with Decision Criterion of SI ≥ 2.0 (14 pages) [PDF]
- Draft Test Method Recommendations (5 pages) [PDF]
LLNA Modification by Daicel Chemical Industries, Ltd. Based on ATP Content (LLNA: DA)
- Draft Background Review Document
View Background Review Document with all appendices (239 pages) [PDF]
- Main Body (97 pages) [PDF]
- Appendix A: Standard Operating Procedures for the LLNA: DA Test Method (24 pages)
[PDF]
- Appendix B: Physico-Chemical Properties and Chemical Classes of Substances Tested in the
LLNA: DA (10 pages) [PDF]
- Appendix C: Comparative LLNA: DA, Traditional LLNA, Guinea Pig, and Human Skin Sensitization Data (26 pages) [PDF]
- Appendix D: Data for the LLNA: DA Intralaboratory and Interlaboratory Validation Studies (62 pages) [PDF]
- Appendix E: LLNA: DA Accuracy Analysis Using Additional Approaches for Combining Multiple Test Results (20 pages)
[PDF]
- Appendix F: Reproducibility Analyses for the LLNA: DA Using a Decision Criterion of SI ≥ 3.0 or SI ≥ 2.0 (19 pages)
[PDF]
- Draft Test Method Recommendations (6 pages)
[PDF]
Flow Cytometry Test Method (LLNA: BrdU-FC)
- Draft Background Review Document
View Background Review Document with all appendices (115 pages) [PDF]
- Main Body (56 pages) [PDF]
- Appendix A: LLNA: BrdU-FC Test Method Submission from MB Research Labs (14 pages) [PDF]
- Appendix B: Physico-Chemical Properties of Substances Tested Using the LLNA: BrdU-FC and the eLLNA: BrdU-FC Protocol (12 pages)
[PDF]
- Appendix C: Comparative LLNA: BrdU-FC, Traditional LLNA, Guinea Pig Skin Sensitization, and Human Data
(6 pages) [PDF]
- Appendix D: MB Research Laboratories LLNA: BrdU-FC Historical Data and Supplementary Studies Submitted in August 2008
(27 pages) [PDF]
- Draft Test Method Recommendations (5 pages)
[PDF]
Applicability Domain for the Murine Local Lymph Node Assay
- Draft Background Review Document
View Background Review Document with all appendices (415 pages) [PDF]
- Main Body (86 pages) [PDF]
- Appendix A: The Murine Local Lymph Node Assay (LLNA): A
Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/Compounds (NIH Pub. No. 99-4494) (211 pages) [PDF on the NICEATM-ICCVAM website]
- Appendix B: Available Data and Information for Pesticide formulations and Other Products Tested in the LLNA
- Appendix B1: Physico-Chemical Properties and Chemical Classes of Pesticide Formulations Tested in the LLNA
(Sorted Alphabetically) (28 pages) [PDF]
- Appendix B2: Pesticide Formulations Tested in the LLNA - Comparative Data (Sorted Alphabetically)
(6 pages) [PDF]
- Appendix B3: Composition of Pesticide Formulations Tested in the LLNA (8 pages) [PDF]
- Appendix B4: Physico-Chemical Properties and Chemical Classes of Dye Formulations Tested in the LLNA
(4 pages) [PDF]
- Appendix B5: Dye Formulations Tested in the LLNA - Comparative Data (Sorted Alphabetically)
(4 pages) [PDF]
- Appendix B6: Physico-Chemical Properties and Chemical Classes of Fragrance Ingredients Tested in the LLNA
(4 pages) [PDF]
- Appendix B7: Fragrance Ingredients Tested in the LLNA - Comparative Data (Sorted Alphabetically)
(4 pages) [PDF]
- Appendix C: Available Data and Information for Metals Tested in the LLNA
- Appendix C1: Physico-Chemical Properties and Chemical Classes of Metals
Analyzed in the Applicability Domain of the LLNA (6 pages) [PDF]
- Appendix C2: Metals Tested in the LLNA - Comparative Data (Sorted Alphabetically) (6 pages) [PDF]
- Appendix D: Available Data and Information for Substances in Aqueous Solutions Tested in the LLNA
- Appendix D1: Physico-Chemical Properties and Chemical Classes of Substances
Tested in Aqueous Solutions in the LLNA (Sorted Alphabetically) (30 pages) [PDF]
- Appendix D2: Substances Tested in Aqueous Solutions in the LLNA
- Comparative Data (Sorted Alphabetically) (6 pages) [PDF]
- Appendix D3: Medical Device Eluates Tested in Aqueous
Solutions in the LLNA - Comparative Data (4 pages) [PDF]
- Appendix E: Supplementary Analysis of Pesticide Formulations in the LLNA (8 pages) [PDF]
- Draft Recommendations on the Updated Assessment of the Validity of the LLNA for Testing
Pesticide Formulations and Other Products, Metals, and Substances in Aqueous Solutions (6 pages)
[PDF]
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