PMID- 21539884 OWN - NLM STAT- MEDLINE DCOM- 20111215 LR - 20110711 IS - 1096-0295 (Electronic) IS - 0273-2300 (Linking) VI - 60 IP - 3 DP - 2011 Aug TI - The regulatory use of the Local Lymph Node Assay for the notification of new chemicals in Europe. PG - 300-7 LID - 10.1016/j.yrtph.2011.04.006 [doi] AB - The regulatory use of the Local Lymph Node Assay (LLNA) for new chemicals registration was monitored by screening the New Chemicals Database (NCD), which was managed by the former European Chemicals Bureau (ECB) at the European Commission Joint Research Centre (JRC). The NCD centralised information for chemicals notified after 1981, where toxicological information has been generated predominantly according to approved test methods. The database was searched to extract notifications for which the information for skin sensitisation labelling was based on results derived with the LLNA. The details of these records were extracted and pooled, and evaluated with regard to the extent of use of the LLNA over time, as well as for analysing the information retrieved on critical aspects of the procedure e.g. strain and amount of animals used, lymph node processing, solvent and doses selected, stimulation indices, and for assessing their level of compliance to the OECD Test Guideline 429. In addition the accuracy of the reduced LLNA when applied to new chemicals was investigated. CI - Copyright (c) 2011 Elsevier Inc. All rights reserved. FAU - Angers-Loustau, Alexandre AU - Angers-Loustau A AD - In Vitro Methods Unit/ECVAM, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy. FAU - Tosti, Luca AU - Tosti L FAU - Casati, Silvia AU - Casati S LA - eng PT - Journal Article DEP - 20110424 PL - Netherlands TA - Regul Toxicol Pharmacol JT - Regulatory toxicology and pharmacology : RTP JID - 8214983 RN - 0 (Irritants) SB - IM MH - Animals MH - Data Mining MH - Databases, Factual MH - Dermatitis, Allergic Contact/etiology/immunology/pathology MH - Dose-Response Relationship, Drug MH - Drug Approval/*methods MH - Drug Evaluation, Preclinical/*methods MH - European Union MH - Female MH - Immunization/methods MH - Irritants/analysis/immunology MH - *Local Lymph Node Assay MH - Mice MH - Mice, Inbred CBA MH - Skin/*drug effects/immunology/pathology EDAT- 2011/05/05 06:00 MHDA- 2011/12/16 06:00 CRDT- 2011/05/05 06:00 PHST- 2010/11/04 00:00 [received] PHST- 2011/04/13 00:00 [revised] PHST- 2011/04/14 00:00 [accepted] PHST- 2011/05/05 06:00 [entrez] PHST- 2011/05/05 06:00 [pubmed] PHST- 2011/12/16 06:00 [medline] AID - S0273-2300(11)00074-2 [pii] AID - 10.1016/j.yrtph.2011.04.006 [doi] PST - ppublish SO - Regul Toxicol Pharmacol. 2011 Aug;60(3):300-7. doi: 10.1016/j.yrtph.2011.04.006. Epub 2011 Apr 24.