PMID- 11754531 OWN - NLM STAT- MEDLINE DCOM- 20020426 LR - 20071115 IS - 0273-2300 (Print) IS - 0273-2300 (Linking) VI - 34 IP - 3 DP - 2001 Dec TI - ICCVAM evaluation of the murine local lymph node assay. Data analyses completed by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods. PG - 274-86 AB - To evaluate 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. FAU - Haneke, K E AU - Haneke KE AD - National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institute of Environmental Health Sciences, MD EC-17, Research Triangle Park, NC 27709, USA. FAU - Tice, R R AU - Tice RR FAU - Carson, B L AU - Carson BL FAU - Margolin, B H AU - Margolin BH FAU - Stokes, W S AU - Stokes WS LA - eng GR - N01-ES-85424/ES/NIEHS NIH HHS/United States PT - Journal Article PT - Research Support, U.S. Gov't, P.H.S. PL - Netherlands TA - Regul Toxicol Pharmacol JT - Regulatory toxicology and pharmacology : RTP JID - 8214983 RN - 0 (Organic Chemicals) SB - IM MH - Animal Welfare MH - Animals MH - Dermatitis, Allergic Contact/diagnosis/economics/*etiology MH - Environmental Exposure/economics/statistics & numerical data MH - Government Agencies/economics/statistics & numerical data MH - Guideline Adherence MH - Guidelines as Topic/standards MH - Guinea Pigs MH - Humans MH - *Interinstitutional Relations MH - *Local Lymph Node Assay MH - Lymph Nodes/drug effects MH - Mice MH - Organic Chemicals/analysis/*toxicity MH - Peer Review/methods/standards MH - Reproducibility of Results MH - Risk Assessment/economics/statistics & numerical data MH - Sensitivity and Specificity MH - Toxicity Tests/economics/methods/*statistics & numerical data MH - United States EDAT- 2002/01/05 10:00 MHDA- 2002/04/27 10:01 CRDT- 2002/01/05 10:00 PHST- 2002/01/05 10:00 [pubmed] PHST- 2002/04/27 10:01 [medline] PHST- 2002/01/05 10:00 [entrez] AID - S0273230001914989 [pii] AID - 10.1006/rtph.2001.1498 [doi] PST - ppublish SO - Regul Toxicol Pharmacol. 2001 Dec;34(3):274-86. doi: 10.1006/rtph.2001.1498.