Application of omics data in regulatory toxicology: report of an international BfR expert workshop.
Advances in omics techniques and molecular toxicology are necessary to provide new perspectives for regulatory toxicology. By the application of modern molecular techniques, more mechanistic information should be gained to support standard toxicity studies and to contribute to a reduction and refinement of animal experiments required for certain regulatory purposes. The relevance and applicability of data obtained by omics methods to regulatory purposes such as grouping of chemicals, mode of action analysis or classification and labelling needs further improvement, defined validation and cautious expert judgment. Based on the results of an international expert workshop organized 2014 by the Federal Institute for Risk Assessment in Berlin, this paper is aimed to provide a critical overview of the regulatory relevance and reliability of omics methods, basic requirements on data quality and validation, as well as regulatory criteria to decide which effects observed by omics methods should be considered adverse or non-adverse. As a way forward, it was concluded that the inclusion of omics data can facilitate a more flexible approach for regulatory risk assessment and may help to reduce or refine animal testing.
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany. philip.marx-stoelting@bfr.bund.de.
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Marx-Stoelting
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Braeuning
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Buhrke
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Lampen
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Niemann
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Oelgeschlaeger
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Rieke
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Schmidt
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Heise
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Pfeil
Federal Institute for Risk Assessment, Max-Dohrn-Str 8-10, 10589, Berlin, Germany.
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Solecki
D000826:Animal Testing Alternatives; D000818:Animals; D006801:Humans; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods*; D018675:Toxicity Tests / Q000379:methods*; D014116:Toxicology / Q000331:legislation & jurisprudence / Q000379:methods*