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Local Lymph Node Assay

Table of Contents

1. Test Submission
   1. Cover Letter
   2. Submission
2. Appendices
   1. Local Lymph Node Assay Bibliography
   2. List of Chemicals
      1. Chemicals Tested in Local Lymph Node Assay
      2. Discordant Results Between Local Lymph Node Assay and Guinea Pig or Human Test Methods
      3. Disintegrations Per Minute Data and Stimulation Indices for Discordant Results
   3. Key Local Lymph Node Assay Papers
   4. Sample Local Lymph Node Assay Protocol
   5. ICCVAM Local Lymph Node Assay Test Submission Guidelines

APPENDIX E

ICCVAM Test Method Submission Guidelines for the LLNA September 11, 1997

1. INTRODUCTION AND RATIONAL
   1. Indicate the scientific and regulatory rationale for the test method.
   2. Describe the mechanistic and/or empirical basis of the proposed test.
   3. Discuss the intended use of the test method.
      1. What steps should be taken when the LLNA gives a positive result?
      2. How are positive or negative results used?
      3. What further steps, if any, are taken if a negative result is obtained?
      4. What role is proposed for the LLNA in the identification of respiratory sensitizers?
      5. Is the LLNA being proposed to identify such chemicals?
   4. Indicate, as appropriate, if and how the proposed method can replace current tests.
   5. Describe, if applicable, how the proposed method may reduce, refine, or replace animal use.
   6. Give the cost and time requirements relative to current procedures.
   7. Provide estimate of number of laboratories currently performing LLNA (include labs not involved in the validation process).
2. TEST METHOD PROTOCOL
   1. Provide the detailed protocol for the test method, including a complete description of the test model or substrate, duration of exposure, animal strain, known limits of use, and nature of the response assessed.
      1. What are the suggested positive or negative controls?
      2. What will be used as a control for irritation?
      3. What strain(s) will be used or accepted for use in this protocol?
   2. Describe the nature of the data to be collected, including the endpoints measured and observations recorded, measures of variability, dose-response measurement, number of replicate studies.
      • Describe in detail the dose selection procedures, especially for unknowns.
      • Describe the number of animals used for dose selections.
   3. Summarize control data, including number of trials, measures of central tendency, and variability, etc.
3. Chracterization of Materials Tested
   1. Describe the chemicals/products evaluated:
      • Chemical and/or product names
      • CAS number(s)
      • Chemical and/or product class
      • Category
      • If mixture, describe all compounds and their proportion
      • Physical/chemical characteristics (e.g. water and liquid solubility)
   2. Describe coding used (if any) during validation studies.
      • Specifically address blinding of chemicals, e.g. which validation studies, and which chemicals (i.e. specifically identify database(s) where chemicals were blinded).

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D. SUPPORTING MATERIALS

1. Provide copies of all relevant publications.
2. Summarize and provide the results of any peer reviews conducted on data, and summarize any other ongoing or planned reviews.
   1. What data were provided to OECD for their evaluations?
   2. What did OECD see as a limitation of the LLNA?
   3. What data have been genereated since the OECD application?
3. Discuss the availability of laboratory notebooks for audits.