Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8551911 | Regulatory Toxicology and Pharmacology | 2017 | 13 Pages |
Abstract
This survey by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) highlights that 'omics technologies are generally not yet applied to meet standard information requirements during regulatory hazard assessment. While they are used within weight-of-evidence approaches to investigate substances' modes-of-action, consistent approaches for the generation, processing and interpretation of 'omics data are not applied. To date, no 'omics technology has been standardised or validated. Best practices for performing 'omics studies for regulatory purposes (e.g., microarrays for transcriptome profiling) remain to be established. Therefore, three frameworks for (i) establishing a Good-Laboratory Practice-like context for collecting, storing and curating 'omics data; (ii) 'omics data processing; and (iii) quantitative WoE approaches to interpret 'omics data have been developed, that are presented in this journal supplement. Application of the frameworks will enable between-study comparison of results, which will facilitate the regulatory applicability of 'omics data. The frameworks do not constitute prescriptive protocols precluding any other data analysis method, but provide a baseline for analysis that can be applied to all data allowing ready cross-comparison. Data analysis that does not follow the frameworks can be justified and the resulting data can be compared with the Framework-based common analysis output.
Keywords
DNELGHSDMELOmicsECETOCECHAGLPMIEMOAIPCsCeficC&LEuropean Chemical Industry CouncilMADOECDEURL ECVAMNRCAOPTRFCLPCEBSqRT-PCRPHEWOEPODLRIITSEuropean Union Reference Laboratory for Alternatives to Animal TestingEuropean Chemicals AgencyHazard assessmentIntegrated testing strategyInternational Programme on Chemical SafetyPublic Health EnglandGood Laboratory PracticeMode-of-actiontest guidelineREACHmolecular initiating eventWorld Health OrganisationDerived No Effect LevelRegulatory toxicologyDEGNational Research Councilclassification and labellingMIAMETranscriptomicsPlant protection productsadverse outcome pathwayWeight-of-evidenceDifferentially expressed geneWHOIATA
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Authors
Ursula G. Sauer, Lize Deferme, Laura Gribaldo, Jörg Hackermüller, Tewes Tralau, Ben van Ravenzwaay, Carole Yauk, Alan Poole, Weida Tong, Timothy W. Gant,