PMID- 22374415 OWN - NLM STAT- MEDLINE DCOM- 20120830 LR - 20120507 IS - 1096-0295 (Electronic) IS - 0273-2300 (Linking) VI - 63 IP - 1 DP - 2012 Jun TI - Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: skin sensitisation. PG - 40-52 LID - 10.1016/j.yrtph.2012.02.007 [doi] AB - Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 'gold standard' test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area. CI - Copyright (c) 2012 Elsevier Inc. All rights reserved. FAU - Goebel, Carsten AU - Goebel C AD - Procter & Gamble, Berliner Allee 65, 64274 Darmstadt, Germany. FAU - Aeby, Pierre AU - Aeby P FAU - Ade, Nadege AU - Ade N FAU - Alepee, Nathalie AU - Alepee N FAU - Aptula, Aynur AU - Aptula A FAU - Araki, Daisuke AU - Araki D FAU - Dufour, Eric AU - Dufour E FAU - Gilmour, Nicola AU - Gilmour N FAU - Hibatallah, Jalila AU - Hibatallah J FAU - Keller, Detlef AU - Keller D FAU - Kern, Petra AU - Kern P FAU - Kirst, Annette AU - Kirst A FAU - Marrec-Fairley, Monique AU - Marrec-Fairley M FAU - Maxwell, Gavin AU - Maxwell G FAU - Rowland, Joanna AU - Rowland J FAU - Safford, Bob AU - Safford B FAU - Schellauf, Florian AU - Schellauf F FAU - Schepky, Andreas AU - Schepky A FAU - Seaman, Chris AU - Seaman C FAU - Teichert, Thomas AU - Teichert T FAU - Tessier, Nicolas AU - Tessier N FAU - Teissier, Silvia AU - Teissier S FAU - Weltzien, Hans Ulrich AU - Weltzien HU FAU - Winkler, Petra AU - Winkler P FAU - Scheel, Julia AU - Scheel J LA - eng PT - Journal Article DEP - 20120221 PL - Netherlands TA - Regul Toxicol Pharmacol JT - Regulatory toxicology and pharmacology : RTP JID - 8214983 RN - 0 (Allergens) RN - 0 (Cosmetics) SB - IM MH - Allergens/*toxicity MH - *Animal Testing Alternatives MH - *Consumer Product Safety MH - Cosmetics/*toxicity MH - Hypersensitivity/*etiology MH - Risk Assessment/methods MH - Skin/*drug effects/immunology EDAT- 2012/03/01 06:00 MHDA- 2012/08/31 06:00 CRDT- 2012/03/01 06:00 PHST- 2011/02/25 00:00 [received] PHST- 2012/02/10 00:00 [revised] PHST- 2012/02/11 00:00 [accepted] PHST- 2012/03/01 06:00 [entrez] PHST- 2012/03/01 06:00 [pubmed] PHST- 2012/08/31 06:00 [medline] AID - S0273-2300(12)00033-5 [pii] AID - 10.1016/j.yrtph.2012.02.007 [doi] PST - ppublish SO - Regul Toxicol Pharmacol. 2012 Jun;63(1):40-52. doi: 10.1016/j.yrtph.2012.02.007. Epub 2012 Feb 21.