PMID- 17879259 OWN - NLM STAT- MEDLINE DCOM- 20080715 LR - 20191210 IS - 0260-437X (Print) IS - 0260-437X (Linking) VI - 28 IP - 4 DP - 2008 May TI - The reduced local lymph node assay: the impact of group size. PG - 518-23 AB - The local lymph node assay (LLNA) is a skin sensitization test that provides animal welfare benefits. To reduce animal usage further, a modified version (rLLNA) was proposed. Conducting the rLLNA as a screening test with a single high dose group and vehicle control differentiated accurately between skin sensitizers and non-sensitizers. This study examined whether a reduction in animal number/group is feasible. Historical data were utilized to examine the impact of conducting the rLLNA with two mice/group. To assess the effect on the stimulation index (SI) 41 datasets with individual animal data derived using five mice/group were analysed. SIs were calculated on all possible combinations of two control and two high dose group disintegrations per minute (dpm) values. For 25 of 33 sensitizer datasets, > 96% of possible dpm combinations resulted in a calculated SI > 3. The lowest percentages of positive SIs were observed with weak allergens when, in the standard LLNA, the mean SIs would have been nearer to the threshold value of 3. The results indicate that moderate, strong and extreme allergens are more likely than weak allergens to be identified as sensitizers when group sizes of two mice are used within the rLLNA. It is concluded that a rLLNA with two mice/group would display decreased sensitivity and is inappropriate for use in hazard identification. CI - Copyright (c) 2007 John Wiley & Sons, Ltd. FAU - Ryan, Cindy A AU - Ryan CA AD - The Procter & Gamble Company, Cincinnati, OH 45253-8707, USA. ryan.ca@pg.com FAU - Chaney, Joel G AU - Chaney JG FAU - Kern, Petra S AU - Kern PS FAU - Patlewicz, Grace Y AU - Patlewicz GY FAU - Basketter, David A AU - Basketter DA FAU - Betts, Catherine J AU - Betts CJ FAU - Dearman, Rebecca J AU - Dearman RJ FAU - Kimber, Ian AU - Kimber I FAU - Gerberick, G Frank AU - Gerberick GF LA - eng PT - Evaluation Study PT - Journal Article PL - England TA - J Appl Toxicol JT - Journal of applied toxicology : JAT JID - 8109495 RN - 0 (Allergens) RN - 0 (Irritants) SB - IM MH - Allergens/*toxicity MH - Animals MH - Dermatitis, Allergic Contact/etiology MH - Dermatitis, Contact/*etiology MH - Dose-Response Relationship, Drug MH - Feasibility Studies MH - Female MH - Irritants/*toxicity MH - *Local Lymph Node Assay MH - Lymph Nodes/*drug effects/pathology MH - Mice MH - Mice, Inbred CBA MH - Reproducibility of Results MH - *Research Design MH - Risk Assessment MH - Sample Size EDAT- 2007/09/20 09:00 MHDA- 2008/07/17 09:00 CRDT- 2007/09/20 09:00 PHST- 2007/09/20 09:00 [pubmed] PHST- 2008/07/17 09:00 [medline] PHST- 2007/09/20 09:00 [entrez] AID - 10.1002/jat.1303 [doi] PST - ppublish SO - J Appl Toxicol. 2008 May;28(4):518-23. doi: 10.1002/jat.1303.