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Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

image of Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals. The document is intended to provide guidance for evaluating chemical using standardised test guidelines. Specific objectives include providing a description of the OECD conceptual framework for evaluating chemicals for endocrine disruption, background on the standardised test methods used, and guidance for interpreting the outcome of individual tests. The general approach taken by the document is primarily to provide guidance on how test results might be interpreted based on the outcome of standardised assays. Key questions addressed in the document concern likely mechanisms of endocrine action and any resulting apical effects that can be attributed to such action. The document is not proscriptive but provides suggestions for possible next steps in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios. The guidance document is focused primarily on endocrine modalities included in the conceptual framework; estrogen, androgen, and thyroid mediated endocrine disruption and chemicals that interfer with steroidogenesis.

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Fish, Early-Life Stage (FELS) Toxicity Test (OECD TG 210)

TG 210 is an OECD validated test intended to define the lethal and sub-lethal effects of chemicals on the early life stages of the species tested. The early-life stages of fish are exposed to five concentrations of the test substance dissolved in water, preferably under flow-through conditions, or where appropriate, semi-static conditions. The test starts with placing fertilised eggs (at least 80 per concentration level) in the test chambers (four at the minimum) and continues at least until all the control fishes are free-feeding. Lethal and sub-lethal effects are assessed and compared with control values to either determine the lowest observed effect concentration and the no observed effect concentration, or the effect concentration leading to x% change on organisms for the effect observed. The study report should include measurement of the concentrations of the test substance in water at regular intervals (five at least), the dissolved oxygen, the temperature, pH, total hardness and salinity, fish weight and length, observations of abnormal appearance, abnormal behaviour, hatching and survival, as well as the no-observed effect level or the effect concentration leading to x% change in the organisms for the effect observed.

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