ICCVAM Evaluation of the Murine Local Lymph Node Assay: III. Data Analyses Completed by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods
DOI: 10.1006/rtph.2001.1498
Title: ICCVAM Evaluation of the Murine Local Lymph Node Assay: III. Data Analyses Completed by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods
Journal Title: Regulatory Toxicology and Pharmacology
Volume: 34
Issue: 3
Publication Date: December 2001
Start Page: 274
End Page: 286
Published online: online 12 March 2002
ISSN: 0273-2300
Author: Karen E. Hanekeab, Raymond R. Ticeab, Bonnie L. Carsonab, Barry H. Margolinac, William S. Stokesa
Affiliations:

  • a National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, MD EC-17, P.O. Box 12233, Research Triangle Park, North Carolina, 27709

  • b ILS, Inc. P.O. Box 13501, Research Triangle Park, North Carolina, 27709

  • c Department of Biostatistics, University of North Carolina at Chapel Hill, Campus Box 7400, Chapel Hill, North Carolina, 27599
  • Abstract: ate the reliability of the Murine local lymph node assay (LLNA), a test for allergic contact dermatitis activity, the inter- and intralaboratory consistency statistics (h and k, respectively) were calculated for validation studies testing multiple chemicals. The analysis indicated the absence of excessive variability in the dose calculated to induce a threefold or greater increase in the stimulation index (SI). To assess the appropriateness of using an SI of 3 as the decision criteria for identifying a sensitizing compound, LLNA results based on SI values of 2.0, 2.5, 3.0, 3.5, and 4.0 were compared with guinea pig or human results. The results supported the use of an SI of 3 as the decision criteria. Assay performance was determined by comparing LLNA results to results obtained for guinea pigs or humans. The accuracy of the LLNA was 89% when compared with results from the guinea pig maximization test (GPMT)/Buehler assay (BA). The performance of the LLNA and the GPMT/BA was similar when each was compared to human maximization test results plus substances included as human patch test allergens. The LLNA offered advantages over the GPMT in respect to both the time required to conduct the test and the assay cost.
    Received: 9 May 2001
    Abbreviations: allergic contact dermatitis

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