PMID- 29474122 OWN - NLM STAT- MEDLINE DCOM- 20190624 LR - 20240216 IS - 1547-6898 (Electronic) IS - 1040-8444 (Print) IS - 1040-8444 (Linking) VI - 48 IP - 5 DP - 2018 May TI - Non-animal methods to predict skin sensitization (II): an assessment of defined approaches (*). PG - 359-374 LID - 10.1080/10408444.2018.1429386 [doi] AB - Skin sensitization is a toxicity endpoint of widespread concern, for which the mechanistic understanding and concurrent necessity for non-animal testing approaches have evolved to a critical juncture, with many available options for predicting sensitization without using animals. Cosmetics Europe and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods collaborated to analyze the performance of multiple non-animal data integration approaches for the skin sensitization safety assessment of cosmetics ingredients. The Cosmetics Europe Skin Tolerance Task Force (STTF) collected and generated data on 128 substances in multiple in vitro and in chemico skin sensitization assays selected based on a systematic assessment by the STTF. These assays, together with certain in silico predictions, are key components of various non-animal testing strategies that have been submitted to the Organization for Economic Cooperation and Development as case studies for skin sensitization. Curated murine local lymph node assay (LLNA) and human skin sensitization data were used to evaluate the performance of six defined approaches, comprising eight non-animal testing strategies, for both hazard and potency characterization. Defined approaches examined included consensus methods, artificial neural networks, support vector machine models, Bayesian networks, and decision trees, most of which were reproduced using open source software tools. Multiple non-animal testing strategies incorporating in vitro, in chemico, and in silico inputs demonstrated equivalent or superior performance to the LLNA when compared to both animal and human data for skin sensitization. FAU - Kleinstreuer, Nicole C AU - Kleinstreuer NC AD - a NIH/NIEHS/DNTP/NICEATM , Research Triangle Park , NC , USA. FAU - Hoffmann, Sebastian AU - Hoffmann S AD - b SEH Consulting + Services , Paderborn , Germany. FAU - Alepee, Nathalie AU - Alepee N AD - c L'Oreal Research & Innovation , Aulnay-sous-Bois , France. FAU - Allen, David AU - Allen D AD - d ILS , Research Triangle Park , NC , USA. FAU - Ashikaga, Takao AU - Ashikaga T AD - e Shiseido , Yokohama-shi , Kanagawa , Japan. FAU - Casey, Warren AU - Casey W AD - a NIH/NIEHS/DNTP/NICEATM , Research Triangle Park , NC , USA. FAU - Clouet, Elodie AU - Clouet E AD - f Pierre Fabre , Toulouse , France. FAU - Cluzel, Magalie AU - Cluzel M AD - g LVMH , St Jean de Braye , France. FAU - Desprez, Bertrand AU - Desprez B AD - h Cosmetics Europe , Brussels , Belgium. FAU - Gellatly, Nichola AU - Gellatly N AD - i Unilever , London , UK. FAU - Gobel, Carsten AU - Gobel C AD - j Coty , Darmstadt , Germany. FAU - Kern, Petra S AU - Kern PS AD - k Procter & Gamble Services Company NV , Strombeek-Bever , Belgium. FAU - Klaric, Martina AU - Klaric M AD - h Cosmetics Europe , Brussels , Belgium. FAU - Kuhnl, Jochen AU - Kuhnl J AD - l Beiersdorf AG , Hamburg , Germany. FAU - Martinozzi-Teissier, Silvia AU - Martinozzi-Teissier S AD - c L'Oreal Research & Innovation , Aulnay-sous-Bois , France. FAU - Mewes, Karsten AU - Mewes K AD - m Henkel AG & Co. KGaA , Dusseldorf , Germany. FAU - Miyazawa, Masaaki AU - Miyazawa M AD - n Kao Corporation , Haga , Tochigi , Japan. FAU - Strickland, Judy AU - Strickland J AD - d ILS , Research Triangle Park , NC , USA. FAU - van Vliet, Erwin AU - van Vliet E AD - o Services & Consultations on Alternative Methods (SeCAM) , Magliaso , Switzerland. FAU - Zang, Qingda AU - Zang Q AD - d ILS , Research Triangle Park , NC , USA. FAU - Petersohn, Dirk AU - Petersohn D AD - m Henkel AG & Co. KGaA , Dusseldorf , Germany. LA - eng GR - HHSN273201500010C/ES/NIEHS NIH HHS/United States GR - Z99 ES999999/ImNIH/Intramural NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20180223 PL - England TA - Crit Rev Toxicol JT - Critical reviews in toxicology JID - 8914275 RN - 0 (Cosmetics) SB - IM MH - Animal Testing Alternatives/*methods MH - Animals MH - Computational Biology/*methods MH - *Computer Simulation MH - Cosmetics/*adverse effects/pharmacology MH - Dermatitis, Allergic Contact/etiology/*immunology MH - Humans MH - Mice MH - Skin/drug effects/*immunology PMC - PMC7393691 MID - NIHMS1505204 OTO - NOTNLM OT - LLNA reference data OT - Skin sensitization OT - adverse outcome pathway OT - defined approaches OT - hazard assessment OT - human reference data OT - integrated testing strategy OT - new approach methodologies OT - potency assessment EDAT- 2018/02/24 06:00 MHDA- 2019/06/25 06:00 PMCR- 2020/07/31 CRDT- 2018/02/24 06:00 PHST- 2018/02/24 06:00 [pubmed] PHST- 2019/06/25 06:00 [medline] PHST- 2018/02/24 06:00 [entrez] PHST- 2020/07/31 00:00 [pmc-release] AID - 10.1080/10408444.2018.1429386 [doi] PST - ppublish SO - Crit Rev Toxicol. 2018 May;48(5):359-374. doi: 10.1080/10408444.2018.1429386. Epub 2018 Feb 23.