PMID- 17627643 OWN - NLM STAT- MEDLINE DCOM- 20071009 LR - 20151119 IS - 0105-1873 (Print) IS - 0105-1873 (Linking) VI - 57 IP - 2 DP - 2007 Aug TI - The local lymph node assay and the assessment of relative potency: status of validation. PG - 70-5 AB - For the prediction of skin sensitization potential, the local lymph node assay (LLNA) is a fully validated alternative to guinea-pig tests. More recently, information from LLNA dose-response analyses has been used to assess the relative potency of skin sensitizing chemicals. These data are then deployed for risk assessment and risk management. In this commentary, the utility and validity of these relative potency measurements are reviewed. It is concluded that the LLNA does provide a valuable assessment of relative sensitizing potency in the form of the estimated concentration of a chemical required to produce a threefold stimulation of draining lymph node cell proliferation compared with concurrent controls (EC3 value) and that all reasonable validation requirements have been addressed successfully. EC3 measurements are reproducible in both intra- and interlaboratory evaluations and are stable over time. It has been shown also, by several independent groups, that EC3 values correlate closely with data on relative human skin sensitization potency. Consequently, the recommendation made here is that LLNA EC3 measurements should now be regarded as a validated method for the determination of the relative potency of skin sensitizing chemicals, a conclusion that has already been reached by a number of independent expert groups. FAU - Basketter, David A AU - Basketter DA AD - Unilever Safety and Environmental Assurance Centre, Colworth Park, Sharnbrook, Bedfordshire, UK. david.basketter@unilever.com FAU - Gerberick, Frank AU - Gerberick F FAU - Kimber, Ian AU - Kimber I LA - eng PT - Journal Article PT - Review PL - England TA - Contact Dermatitis JT - Contact dermatitis JID - 7604950 RN - 0 (Allergens) SB - IM MH - Allergens/pharmacology MH - Dermatitis, Allergic Contact/*diagnosis MH - Dose-Response Relationship, Drug MH - Humans MH - *Local Lymph Node Assay MH - Reproducibility of Results MH - Skin/drug effects RF - 53 EDAT- 2007/07/14 09:00 MHDA- 2007/10/10 09:00 CRDT- 2007/07/14 09:00 PHST- 2007/07/14 09:00 [pubmed] PHST- 2007/10/10 09:00 [medline] PHST- 2007/07/14 09:00 [entrez] AID - COD1141 [pii] AID - 10.1111/j.1600-0536.2007.01141.x [doi] PST - ppublish SO - Contact Dermatitis. 2007 Aug;57(2):70-5. doi: 10.1111/j.1600-0536.2007.01141.x.