PMID- 11754530 OWN - NLM STAT- MEDLINE DCOM- 20020426 LR - 20220311 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. Conclusions and recommendations of an independent scientific peer review panel. PG - 258-73 AB - The validation status of the murine local lymph node assay (LLNA), a method for assessing the allergic contact dermatitis potential of chemicals, was evaluated by an independent peer review panel (Panel) convened by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The LLNA measures lymphocyte proliferation using incorporation of radioactive thymidine or iododeoxyuridine into cells of the draining lymph nodes of mice topically exposed to a test article. The Panel concluded that the assay performed 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 correctly identify all weak sensitizers or metals (potential false negative response) or all strong irritants (potential false positive response). The Panel concluded also that the LLNA involves less pain and distress than conventional guinea pig methods. The Panel unanimously recommended the LLNA as a stand-alone alternative for contact sensitization hazard assessment, provided that certain protocol modifications were made. These included collection of individual, rather than pooled, animal response data; the inclusion of a concurrent positive control; and consideration of dose-response information and statistical analyses. A standardized LLNA protocol is provided. FAU - Dean, J H AU - Dean JH AD - Sanofi-Synthelabo Research, Sanofi-Synthelabo Inc., Malvern, PA 19355, USA. FAU - Twerdok, L E AU - Twerdok LE FAU - Tice, R R AU - Tice RR FAU - Sailstad, D M AU - Sailstad DM FAU - Hattan, D G AU - Hattan DG FAU - Stokes, W S AU - Stokes WS LA - eng GR - N01-ES-85424/ES/NIEHS NIH HHS/United States PT - Comparative Study 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 - LGP81V5245 (Idoxuridine) RN - VC2W18DGKR (Thymidine) SB - IM MH - Animals MH - Dermatitis, Allergic Contact/diagnosis/*etiology MH - Environmental Exposure/*standards MH - Female MH - Government Agencies/standards MH - Guideline Adherence MH - Guidelines as Topic/standards MH - Guinea Pigs MH - Humans MH - Idoxuridine/administration & dosage MH - *Interinstitutional Relations MH - Isotope Labeling MH - *Local Lymph Node Assay MH - Lymphocytes/physiology MH - Mice MH - Peer Review/methods/standards MH - Reproducibility of Results MH - Risk Assessment MH - Thymidine/administration & dosage MH - Toxicity Tests/methods/*standards 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 - S0273230001914977 [pii] AID - 10.1006/rtph.2001.1497 [doi] PST - ppublish SO - Regul Toxicol Pharmacol. 2001 Dec;34(3):258-73. doi: 10.1006/rtph.2001.1497.