TY - JOUR
T1 - The challenge of the application of 'omics technologies in chemicals risk assessment
T2 - Background and outlook
AU - Sauer, Ursula G.
AU - Deferme, Lize
AU - Gribaldo, Laura
AU - Hackermüller, Jörg
AU - Tralau, Tewes
AU - van Ravenzwaay, Ben
AU - Yauk, Carole
AU - Poole, Alan
AU - Tong, Weida
AU - Gant, Timothy W.
N1 - Publisher Copyright:
© 2017
PY - 2017/12
Y1 - 2017/12
N2 - 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.
AB - 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.
KW - Hazard assessment
KW - Omics
KW - Plant protection products
KW - Registration, Evaluation, Authorisation, and Restriction (REACH)
KW - Regulatory toxicology
KW - Test method standardisation
KW - Test method validation
KW - Transcriptomics
KW - Weight-of-evidence
UR - http://www.scopus.com/inward/record.url?scp=85029718709&partnerID=8YFLogxK
U2 - 10.1016/j.yrtph.2017.09.020
DO - 10.1016/j.yrtph.2017.09.020
M3 - Article
C2 - 28927750
AN - SCOPUS:85029718709
SN - 0273-2300
VL - 91
SP - S14-S26
JO - Regulatory Toxicology and Pharmacology
JF - Regulatory Toxicology and Pharmacology
ER -