Abstract
ERGO (EndocRine Guideline Optimization) is the acronym of a European Union-funded research and innovation action, that aims to break down the wall between mammalian and non-mammalian vertebrate regulatory testing of endocrine disruptors (EDs), by identifying, developing and aligning thyroid-related biomarkers and endpoints (B/E) for the linkage of effects between vertebrate classes. To achieve this, an adverse outcome pathway (AOP) network covering various modes of thyroid hormone disruption (THD) in multiple vertebrate classes will be developed. The AOP development will be based on existing and new data from in vitro and in vivo experiments with fish, amphibians and mammals, using a battery of different THDs. This will provide the scientifically plausible and evidence-based foundation for the selection of B/E and assays in lower vertebrates, predictive of human health outcomes. These assays will be prioritized for validation at OECD (Organization for Economic Cooperation and Development) level. ERGO will re-think ED testing strategies from in silico methods to in vivo testing and develop, optimize and validate existing in vivo and early life-stage OECD guidelines, as well as new in vitro protocols for THD. This strategy will reduce requirements for animal testing by preventing duplication of testing in mammals and non-mammalian vertebrates and increase the screening capacity to enable more chemicals to be tested for ED properties.
Highlights
International workshops and projects arranged by the European Commission (EC) and OECD (Organization for Economic Cooperation and Development) have identified gaps in the testing of suspected endocrine disruptors (EDs) [1,2,3]
Structuring all available scientific evidence according to formal OECD adverse outcome pathway (AOP) development principles and following the OECD review process will support the prioritization of assays for identifying thyroid hormone disruption (THD) across vertebrate classes for validation
Dependent on the TRL of the biomarkers and endpoints (B/E), either a pre-validation will be performed within ERGO or an OECD validation including external participants will be carried out
Summary
International workshops and projects arranged by the European Commission (EC) and OECD (Organization for Economic Cooperation and Development) have identified gaps in the testing of suspected endocrine disruptors (EDs) [1,2,3]. Testing on animals (as defined by Dir. 2010/63/UE) is not allowed in Europe (and some other countries) for the safety assessment of cosmetic ingredients and low tonnage chemicals (less than 10 tonnes/year), which must rely on alternative methods These compounds can only be tested with OECD conceptual framework (CF) level 2 (in vitro) and some level 3 tests (fish and amphibian early life stages). The ERGO approach will be of significant interest for the safety assessment of existing chemicals lacking endocrine and developmental toxicity data and new chemicals at an early stage of their industrial development Assessment at the vitro scale providing new clues for automation and higher throughput screening of chemicals, which would further reduce the cost of their assessment
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