Dean, J., D. Sailstad, D. Hattan, R. Tice, T. Goldsworthy, K. Haneke, R. Hill and W. Stokes. Conclusions of the Interagency Coordinating Committee on the Validation of Alternative Methods-Convened Independent Peer Review Panel Evaluation of the Murine Local Lymph Node Assay. ATLA 27: 332. 1999.

The validation status of the murine Local Lymph Node Assay (LLNA), a test method for assessing the allergic contact dermatitis potential of chemicals, was evaluated in a public meeting in Gaithersburg, MD, USA, by an independent peer review panel (PRP) convened by ICCVAM. The PRP concluded that the assay performed at least as well as currently accepted guinea-pig methods (guinea-pig maximization test [GPMT]/Buehler Assay [BA]) for the hazard identification of strong to moderate chemical sensitizing agents, but that it might not accurately predict all weak, or metal, sensitisers (false negative), or all strong irritants (false positive). When comparing the LLNA to the GPMT/BA, the LLNA appears to provide an equivalent prediction of the risk of human allergic contact dermatitis, while providing quantitative, rather than qualitative, data. The PRP also concluded that the LLNA offers several advantages with respect to refinement of animal use compared to conventional guinea-pig methods, because it involves less pain and distress. The PRP unanimously recommended the LLNA as a stand-alone alternative for contact sensitisation hazard assessment, provided that certain protocol modifications were made. These modifications included the use of individual, rather than pooled, animal response data, a concurrent positive control, and consideration of dose-response information and statistical analyses in the final conclusion. The deliberations and conclusions of the PRP are available in National Institutes of Health (NIH) Publication 99-4494 entitled The Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/Compounds.