PMID- 29730445 OWN - NLM STAT- MEDLINE DCOM- 20181211 LR - 20181211 IS - 1096-0295 (Electronic) IS - 0273-2300 (Linking) VI - 96 DP - 2018 Jul TI - Chemical applicability domain of the local lymph node assay (LLNA) for skin sensitisation potency. Part 4. Quantitative correlation of LLNA potency with human potency. PG - 76-84 LID - S0273-2300(18)30131-4 [pii] LID - 10.1016/j.yrtph.2018.04.022 [doi] AB - Prediction of skin sensitisation potential and potency by non-animal methods is the target of many active research programmes. Although the aim is to predict sensitisation potential and potency in humans, data from the murine local lymph node assay (LLNA) constitute much the largest source of quantitative data on in vivo skin sensitisation. The LLNA has been the preferred in vivo method for identification of skin sensitising chemicals and as such is potentially valuable as a benchmark for assessment of non-animal approaches. However, in common with all predictive test methods, the LLNA is subject to false positives and false negatives with an overall level of accuracy said variously to be approximately 80% or 90%. It is also necessary to consider the extent to which, for true positives, LLNA potency correlates with human potency. In this paper LLNA potency and human potency are compared so as to express quantitatively the correlation between them, and reasons for non-agreement between LLNA and human potency are analysed. This leads to a better definition of the applicability domain of the LLNA, within which LLNA data can be used confidently to predict human potency and as a benchmark to assess the performance of non-animal approaches. CI - Copyright (c) 2018. Published by Elsevier Inc. FAU - Roberts, David W AU - Roberts DW AD - School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool L3 3AF, United Kingdom. Electronic address: d.w.roberts@ljmu.ac.uk. FAU - Api, Anne Marie AU - Api AM AD - Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, United States. LA - eng PT - Journal Article DEP - 20180503 PL - Netherlands TA - Regul Toxicol Pharmacol JT - Regulatory toxicology and pharmacology : RTP JID - 8214983 SB - IM MH - Dermatitis, Allergic Contact/*immunology MH - Humans MH - *Local Lymph Node Assay MH - Skin/*immunology OTO - NOTNLM OT - Applicability domains OT - HRIPT OT - LLNA OT - Quantitative correlation EDAT- 2018/05/08 06:00 MHDA- 2018/12/12 06:00 CRDT- 2018/05/07 06:00 PHST- 2018/01/25 00:00 [received] PHST- 2018/04/23 00:00 [revised] PHST- 2018/04/27 00:00 [accepted] PHST- 2018/05/08 06:00 [pubmed] PHST- 2018/12/12 06:00 [medline] PHST- 2018/05/07 06:00 [entrez] AID - S0273-2300(18)30131-4 [pii] AID - 10.1016/j.yrtph.2018.04.022 [doi] PST - ppublish SO - Regul Toxicol Pharmacol. 2018 Jul;96:76-84. doi: 10.1016/j.yrtph.2018.04.022. Epub 2018 May 3.