Background Review Documents (BRDs)
LLNA Applicability Domain - Draft Updated Assessment of the Validity of the LLNA for Mixtures, Metals, and Aqueous Solutions
- Main Body Text [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)
[PDF]
- Appendix B: Available Data and Information for Mixtures Tested in the LLNA
- Appendix B1 - Physicochemical Properties of Tested Substances [PDF]
- Appendix B2 - Comparative Data: Human, LLNA, Guinea Pig [XLS]
- Appendix C: Available Data and Information for Metals Tested in the LLNA
- Appendix C1 - Physicochemical Properties of Tested Substances [PDF]
- Appendix C2 - Comparative Data: Human, LLNA, Guinea Pig [XLS]
- References for Appendix C2 [PDF]
- Appendix D: Available Data and Information for Aqueous Solutions Tested in the LLNA
- Appendix D1 - Physicochemical Properties of Tested Substances [PDF]
- Appendix D2 - Comparative Data: Human, LLNA, Guinea Pig [XLS]
- References for Appendix D2 [PDF]
- Appendix E: Available Generic Compositions for Substances Tested in the LLNA [PDF]
Draft BRD for Use of the Murine Local Lymph Node Assay to Assess Relative Skin Sensitization
Potency
- Main Body Text [PDF]
- Appendix A: LLNA/EC3 Validation - Submission from: David Basketter, Frank Gerberick and Ian Kimber
[PDF]
- Table 2: Human experimental vs LLNA EC3 thresholds [PDF]
- Appendix B: Comparative LLNA, Guinea Pig, and Human Data Used in the Performance Evaluation
[XLS]
- Appendix C: Physicochemical Properties for Substances Included in the Performance Evaluation
[XLS]
- Appendix D: Performance Characteristics for Use of LLNA EC3 Values to Predict
Draft GHS Categories of Human and Guinea Pig Skin Sensitization Potency
[PDF]
Draft Background Review Document (BRD) for LLNA Limit Dose Procedure
- Main Body Text [PDF]
- Appendix A: ECVAM Scientific Advisory Committee (ESAC) Statement on the rLLNA
[PDF]
- Appendix B: Physico-chemical Properties for Substances Evaluated in the
LLNA Limit Dose Procedure [XLS]
- Appendix C: LLNA Limit Dose Procedure Data [XLS]
- Appendix D: Substances in the NICEATM LLNA Database for Which a Concentration of ≥10% Elicited a Negative Result, but an
Increased Concentration Elicited a Positive Response
[XLS]
Non-radioactive LLNA Protocol BRDs
Flow Cytometry Test Method
- Main Body Text [PDF]
- Appendix A: Flow Cytometery – Local Lymph Node Assay Protocol [PDF]
- Appendix B: Physico-Chemical Properties of Substances Tested Using the LLNA: BrdU-FC/eLLNA: BrdU-FC Protocol
[PDF]
- Appendix C: Comparative LLNA: BRDU-FC/LLNA: BRDU-ELISA, Traditional LLNA, Guinea Pig Skin Sensitization, and Human Data
[PDF]
- Appendix D: MB Research Laboratories LLNA: 25% Hexyl Cinnamic Aldehyde (HCA) Historical Data
[PDF]
BrdU-ELISA Test Method Protocol
- Main Body Text [PDF]
- Appendix A: BrdU-ELISA Local Lymph Node Assay Protocol [PDF]
Supplemental Information:
BrdU-ELISA Local Lymph Node Assay Protocol – Updated By the JaCVAM Interlaboratory Validation Study Management Team (Feb. 27, 2008)
[PDF]
- Appendix B: Analysis of Alternative Decision Criteria for Determination of Sensitizers
[PDF]
- Appendix C: Physico-Chemical Properties of Substances Tested Using the BrdU-ELISA LLNA
[PDF]
- Appendix D: Comparative BrdU-Elisa Local Lymph Node Assay, Traditional Local Lymph Node Assay, Guinea Pig Skin Sensitization, and Human Skin Sensitization Data
[PDF]
LLNA: DA Test Method Protocol
- Main Body Text [PDF]
- Appendix A: Description of the LLNA: DA Protocol [PDF]
- Appendix B: Physico-Chemical Properties and Chemical Classes of Substances Tested in the LLNA: DA
[PDF]
- Appendix C: Comparative LLNA: DA, Traditional LLNA, Guinea Pig Skin Sensitization, and Human Skin Sensitization Data
[PDF]
- Appendix D: Oral Presentations Relating to the Characterization and Validation of the LLNA: DA
[PDF]
- Appendix D-1: Characterization and current status of the LLNA: DA method: a non-RI modified LLNA based on ATP content
[PDF]
- Appendix D-2: Two validation studies on a non-RI Modification of the murine LLNA using ATP measurement
[PDF]
- Appendix D-3: Two validation studies on a non-RI Modification of the murine LLNA using ATP measurement:
method of LLNA: DA and results of intralaboratory studies [PDF]
- Appendix E: Analysis of Alternative Decision Criteria for Predicting Skin Sensitizing Potential in the LLNA: DA
[PDF]
View complete list of documents reviewed by the March 2008 Peer Review Panel
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