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  • 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.

  • 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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  • 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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  • 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.

  • 13-February-2019

    English

    Mutual Acceptance of Data (MAD)

    The OECD has developed the Mutual Acceptance of Data (MAD), a multilateral agreement which allows participating countries (including non members) to share the results of various non-clinical tests done on chemicals using OECD methods and principles. MAD reduces duplicative testing, allows governments to work together when assessing chemicals, and saves government and industry resources.

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  • 28-January-2019

    English

    Saving Costs in Chemicals Management - How the OECD Ensures Benefits to Society

    The chemical industry is one of the largest industrial sectors in the world and is expected to grow fourfold by 2060. Indeed modern life without chemicals would be inconceivable. Given the potential environmental and human health risks from exposure to chemicals, governments and industry have a major responsibility to ensure that chemicals are produced and used safely. The OECD assists countries in developing and implementing policies and instruments that protect human health and the environment, and in making their systems for managing chemicals as efficient as possible. To eliminate duplication of work and avoid non-tariff barriers to trade, emphasis has been on developing shared frameworks for gathering and assessing information on potential chemical risks. The time-tested OECD Mutual Acceptance of Data (MAD) system provides a major basis for generating savings to governments and industry. This report provides an overview of the benefits and estimates the total savings from OECD work to be more than EUR 309 million per year.

  • 4-September-2018

    English

    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.

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  • 4-September-2018

    English

    Guidance Document on Good In Vitro Method Practices (GIVIMP)

    GIVIMP aims to reduce the uncertainties in cell and tissue-based in vitro method derived predictions by applying good scientific, technical and quality practices from method development to implementation for regulatory use. Test method developers and test guideline users will find best practices for designing guideline in vitro methods, carrying out safety tests and assuring quality and scientific integrity of the resulting data

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  • 27-June-2018

    English

    Test No. 433: Acute Inhalation Toxicity: Fixed Concentration Procedure

    This method provides information on health hazard likely to arise from short-term exposure to a test chemical by inhalation. It is a principle of the method that only moderately toxic concentrations are used so that ‘evident toxicity’, rather than death/moribundity is used as an endpoint, and concentrations that are expected to be lethal are avoided. Groups of animals of a single sex are exposed for a short period of time to the test chemical in a stepwise procedure using the appropriate fixed concentrations for vapours, dusts/mists (aerosols) or gases.  Further groups of animals may be tested at higher concentrations in the absence of signs of evident toxicity or mortality at lower concentrations. This procedure continues until the concentration causing evident toxicity or no more than one death/ moribund animal is identified, or when no effects are seen at the highest concentration or when deaths/ moribundity occur at the lowest concentration.  A total of five animals of one sex will normally be used for each concentration level investigated. The results of this study include: measurements (weighing at least weekly) and daily detailed observations, as well as gross necropsy. The method provides information on the hazardous properties and allows the substance to be classified for acute toxicity according to the Globally Harmonised System of classification and labelling of chemicals.  

  • 27-June-2018

    English

    Test No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage

    This Test Guideline describes an in vitro procedure allowing the identification of chemicals (substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS. It makes use of reconstructed human cornea-like epithelium (RhCE) which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The test evaluates the ability of a test chemical to induce cytotoxicity in a RhCE tissue construct, as measured by the MTT assay. Coloured chemicals can also be tested by used of an HPLC procedure. RhCE tissue viability following exposure to a test chemical is measured by enzymatic conversion of the vital dye MTT by the viable cells of the tissue into a blue MTT formazan salt that is quantitatively measured after extraction from tissues. The viability of the RhCE tissue is determined in comparison to tissues treated with the negative control substance (% viability), and is then used to predict the eye hazard potential of the test chemical. Chemicals not requiring classification and labelling according to UN GHS are identified as those that do not decrease tissue viability below a defined threshold (i.e., tissue viability > 60%, for UN GHS No Category).
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