PMID- 29474128 OWN - NLM STAT- MEDLINE DCOM- 20190624 LR - 20190624 IS - 1547-6898 (Electronic) IS - 1040-8444 (Linking) VI - 48 IP - 5 DP - 2018 May TI - Non-animal methods to predict skin sensitization (I): the Cosmetics Europe database. PG - 344-358 LID - 10.1080/10408444.2018.1429385 [doi] AB - Cosmetics Europe, the European Trade Association for the cosmetics and personal care industry, is conducting a multi-phase program to develop regulatory accepted, animal-free testing strategies enabling the cosmetics industry to conduct safety assessments. Based on a systematic evaluation of test methods for skin sensitization, five non-animal test methods (DPRA (Direct Peptide Reactivity Assay), KeratinoSens(TM), h-CLAT (human cell line activation test), U-SENS(TM), SENS-IS) were selected for inclusion in a comprehensive database of 128 substances. Existing data were compiled and completed with newly generated data, the latter amounting to one-third of all data. The database was complemented with human and local lymph node assay (LLNA) reference data, physicochemical properties and use categories, and thoroughly curated. Focused on the availability of human data, the substance selection resulted nevertheless resulted in a high diversity of chemistries in terms of physico-chemical property ranges and use categories. Predictivities of skin sensitization potential and potency, where applicable, were calculated for the LLNA as compared to human data and for the individual test methods compared to both human and LLNA reference data. In addition, various aspects of applicability of the test methods were analyzed. Due to its high level of curation, comprehensiveness, and completeness, we propose our database as a point of reference for the evaluation and development of testing strategies, as done for example in the associated work of Kleinstreuer et al. We encourage the community to use it to meet the challenge of conducting skin sensitization safety assessment without generating new animal data. FAU - Hoffmann, Sebastian AU - Hoffmann S AD - a seh consulting + services , Paderborn , Germany. FAU - Kleinstreuer, Nicole AU - Kleinstreuer N AD - b NIH/NIEHS/DNTP/NICEATM , Research Triangle Park , NC , USA. FAU - Alepee, Nathalie AU - Alepee N AD - c L'Oreal Research and Innovation , Aulnay-sous-Bois , France. FAU - Allen, David AU - Allen D AD - d ILS, Research Triangle Park , NC , USA. FAU - Api, Anne Marie AU - Api AM AD - e The Research Institute for Fragrance Materials (RIFM) , Woodcliff Lake , NJ , USA. FAU - Ashikaga, Takao AU - Ashikaga T AD - f Shiseido Global Innovation Center , Hayabuchi , Kanagawa , Japan. FAU - Clouet, Elodie AU - Clouet E AD - g Pierre Fabre , Toulouse , France. FAU - Cluzel, Magalie AU - Cluzel M AD - h LVMH , St Jean de Braye , France. FAU - Desprez, Bertrand AU - Desprez B AD - i Cosmetics Europe , Brussels , Belgium. FAU - Gellatly, Nichola AU - Gellatly N AD - j Unilever , Bedford , United Kingdom. FAU - Goebel, Carsten AU - Goebel C AD - k Coty , Darmstadt , Germany. FAU - Kern, Petra S AU - Kern PS AD - l Procter and Gamble Services Company NV , Strombeek-Bever , Belgium. FAU - Klaric, Martina AU - Klaric M AD - i Cosmetics Europe , Brussels , Belgium. FAU - Kuhnl, Jochen AU - Kuhnl J AD - m Beiersdorf AG , Hamburg , Germany. FAU - Lalko, Jon F AU - Lalko JF AD - e The Research Institute for Fragrance Materials (RIFM) , Woodcliff Lake , NJ , USA. FAU - Martinozzi-Teissier, Silvia AU - Martinozzi-Teissier S AD - c L'Oreal Research and Innovation , Aulnay-sous-Bois , France. FAU - Mewes, Karsten AU - Mewes K AD - n Henkel AG and Co. KG , Dusseldorf , Germany. FAU - Miyazawa, Masaaki AU - Miyazawa M AD - o Kao Corporation , Tochigi , Japan. FAU - Parakhia, Rahul AU - Parakhia R AD - e The Research Institute for Fragrance Materials (RIFM) , Woodcliff Lake , NJ , USA. FAU - van Vliet, Erwin AU - van Vliet E AD - p Services and 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 - n Henkel AG and Co. KG , Dusseldorf , Germany. LA - eng PT - Journal Article 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 - Cosmetics/*adverse effects/pharmacology MH - *Databases, Factual MH - Dermatitis, Allergic Contact/etiology/*immunology MH - Humans MH - Skin/drug effects/*immunology OTO - NOTNLM OT - LLNA OT - Skin sensitization OT - database OT - defined approach OT - human reference data OT - in chemico OT - in vitro OT - non-animal OT - test methods OT - testing strategy EDAT- 2018/02/24 06:00 MHDA- 2019/06/25 06:00 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] AID - 10.1080/10408444.2018.1429385 [doi] PST - ppublish SO - Crit Rev Toxicol. 2018 May;48(5):344-358. doi: 10.1080/10408444.2018.1429385. Epub 2018 Feb 23.