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  • 4-July-2023

    English

    Test No. 240: Medaka Extended One Generation Reproduction Test (MEOGRT)

    This Test Guideline describes the Medaka Extended One Generation Test (MEOGRT), which exposes fish over multiple generations to give data relevant to ecological hazard and risk assessment of chemicals, including suspected endocrine disrupting chemicals (EDCs).  Exposure in the MEOGRT starts with spawning fish (P or F0 generation) and continues until hatching (until two weeks post fertilization, wpf) in the second (F2) generation. This Test Guideline measures several biological endpoints.  Primary emphasis is given to potential adverse effects on population relevant parameters including survival, gross development, growth and reproduction (fecundity).  Secondarily, in order to provide mechanistic information and provide linkage between results from other kinds of field and laboratory studies, where there is a posteriori evidence for a chemical having potential endocrine disrupter activity (e.g. androgenic or oestrogenic activity in other tests and assays) then other useful information is obtained by measuring vitellogenin (vtg) mRNA (or vitellogenin protein, VTG), phenotypic secondary sex characteristics (SSC) as related to genetic sex, and evaluating histopathology.

  • 4-July-2023

    English

    Test No. 405: Acute Eye Irritation/Corrosion

    This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye. This Test Guideline is intended preferably for use with albino rabbit. The test substance is applied in a single dose in the conjunctival sac of one eye of each animal. The other eye, which remains untreated, serves as a control. The initial test uses an animal; the dose level depends on the test substance nature. A confirmatory test should be made if a corrosive effect is not observed in the initial test, the irritant or negative response should be confirmed using up to two additional animals. It is recommended that it be conducted in a sequential manner in one animal at a time, rather than exposing the two additional animals simultaneously. The duration of the observation period should be sufficient to evaluate fully the magnitude and reversibility of the effects observed. The eyes should be examined at 1, 24, 48, and 72 hours after test substance application. The ocular irritation scores should be evaluated in conjunction with the nature and severity of lesions, and their reversibility or lack of reversibility. Use of topical anesthetics and systemic analgesics to avoid or minimize pain and distress in ocular safety testing procedures is described.

  • 4-July-2023

    English

    Test No. 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals

    This Test Guideline describes in vitro assays, which use Androgen Receptor TransActivation (ARTA) to detect Androgen Receptor Agonists and Antagonists. The ARTA assay methods are mechanistically and functionally similar test methods that provide information on the transcription and translation of a reporter gene following the binding of a chemical to the androgen receptor and subsequent transactivation. The cell lines used in these assays express AR and have been stably transfected with an AR-responsive luciferase reporter gene, and are used to identify chemicals that activate (i.e. act as agonist) or inhibit (i.e. act as antagonists) AR-dependent transcription. Some chemicals may, in a cell type-dependent manner, display both agonist and antagonist activity and are known as selective AR modulators. The AR is activated following ligand binding, after which the receptor-ligand complex binds to specific DNA responsive elements and transactivates the receptor gene, resulting in an increase cellular expression of the luciferase enzyme. The enzyme then transforms the substrate to a bioluminescent product that can be quantitatively measured with a luminometer. This Test Guideline includes ARTA assays using the AR-EcoScreenTM cell line, the AR-CALUX® cell line, and 22Rv1/MMTV_GR-KO cell line.

  • 27-June-2023

    English

    OECD work on in vitro assays for developmental neurotoxicity

    Initial Recommendations on Evaluation of Data from the Developmental Neurotoxicity (DNT) In-Vitro Testing Battery | This document includes the lessons learned from the application of this technology in the field of pharmaceuticals and considers a range of issues directly relevant to human exposure arising from the application of externally-applied dsRNA-based pesticides, and discusses possible effects of dsRNA exposure in mammals.

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  • 11-October-2022

    English

    OECD Good Laboratory Practice: Frequently asked questions (FAQ)

    GLP issues raised by testing labs are covered in this comprehensive list of questions and answers, recently updated with questions related to: Test Facility organisation and personnel, Quality Assurance, Equipment and computerized systems, Test items, reference items and samples/specimens (Biologicals, GMOs, etc.), SOPs, Management of the study, Histopathology, Archives and E-Archives and Monitoring Test Facility compliance by GLP CMAs.

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  • 2-March-2021

    English

    Substitution of hazardous chemicals

    As the demand for safer chemicals grows, the field of alternatives assessment is becoming increasingly important in guiding the transition towards safer, less toxic alternatives. A major limitation that can hinder efforts is the lack of consistent criteria for defining “safer" alternatives. This guidance outlines key considerations for the identification and selection of safer alternatives.

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  • 12-November-2020

    English

    OECD Work Related to Endocrine Disrupters

    The OECD has published the Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption 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.

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  • 2-March-2020

    English

    Section 3 Software: Environmental Fate and Behaviour (Softwares for TG 305 and TG 318)

    Software to be used for Test Guidelines 305 and 318

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  • 10-January-2020

    English

    Series on Testing and Assessment / Adopted Guidance and Review Documents

    These are the OECD Guidelines for the Testing of Chemicals: Testing and Assessment Series Monographs.

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  • 18-June-2019

    English

    Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method

    The test described in this Test Guideline allows the identification of corrosive chemical substances and mixtures and it enables the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using other existing information. The test protocol may also provide an indication of the distinction between severe and less severe skin corrosives. This Test Guideline does not require the use of live animals or animal tissue for the assessment of skin corrosivity. The test material (solid or liquid) is applied uniformly and topically to a three-dimensional human skin model, comprising at least a reconstructed epidermis with a functional stratum corneum. Two tissue replicates are used for each treatment (exposure time), and for controls. Corrosive materials are identified by their ability to produce a decrease in cell viability below defined threshold levels at specified exposure periods. Coloured chemicals can also be tested by used of an HPLC procedure. The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the underlying cell layers.
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