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  • 27-June-2016

    English

    Draft documents for public comments

    This page contains a list of the Guidelines for the Testing of Chemicals.

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  • 25-April-2016

    English

    Application of Good Laboratory Practice Principles to Computerised Systems

    This new Advisory Document replaces the 1995 consensus document on the Application of the Principles of GLP to Computerised Systems. It retains all of the key text from the original 1995 document, but includes new text to reflect the current state-of-the art in this field.

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  • 18-March-2016

    English, PDF, 1,601kb

    Draft Guidance Document on IATA for Eye Hazard Potential

    The objective of the present Guidance Document (GD) is to establish an Integrated 2 Approach to Testing and Assessment (IATA) for hazard identification of serious eye 3 damage and eye irritation potential of test chemicals (or the absence thereof) that 4 provides adequate information for classification and labelling according to the United 5 Nations Globally Harmonised System (UN GHS, 2015).

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  • 3-February-2016

    English

    Avian Toxicity Testing

    This work describes the various endeavours of OECD countries to develop harmonised methodologies for birds toxicity testing, including the successful outcomes or the reasons for stopping activities in some cases. The work has required commitment from countries and industry in terms of staffing and laboratory resources to perform experimental testing and generate data.

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  • 7-January-2016

    English

    Substitution of hazardous chemicals

    A new report has been launched by the OECD Ad Hoc Group on Substitution of Harmful Chemicals. The report identifies where gaps remain in terms of possible missing tools, guidance and research to support stakeholders engaged in alternatives assessment and substitution of harmful chemicals.

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  • 28-July-2015

    English, PDF, 771kb

    Draft Updated Test Guideline 223: Avian Acute Oral Toxicity Test

    This Test Guideline describes procedures designed to estimate the acute oral toxicity of substances to birds, and it provides three testing options: (1) limit dose test, (2) LD50-slope test, and (3) LD50-only test.

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  • 28-July-2015

    English

    Test No. 241: The Larval Amphibian Growth and Development Assay (LAGDA)

    The test guideline of the Larval Amphibian Growth and Development Assay (LAGDA) describes a toxicity test with an amphibian species (African clawed frog (Xenopus laevis)) that considers growth and development from fertilization through the early juvenile period.  It is an assay (typically 16 weeks) that assesses early development, metamorphosis, survival, growth, and partial reproductive maturation. It also enables measurement of a suite of other endpoints that allows for diagnostic evaluation of suspected endocrine disrupting chemicals (EDCs) or other types of developmental and reproductive toxicants. The LAGDA serves as a higher tier test with an amphibian for collecting more comprehensive concentration-response information on adverse effects suitable for use in hazard identification and characterization, and in ecological risk assessment. The general experimental design entails exposing X. laevis embryos at Nieuwkoop and Faber (NF) stage 8-10 (3) to a minimum of four different concentrations of test chemical and control(s) until 10 weeks after the median time to NF stage 62.  There are four replicates in each test concentration with eight replicates for the control. Endpoints evaluated during the course of the exposure (at the interim sub-sample and final sample at completion of the test) include those indicative of generalized toxicity: mortality, abnormal behaviour, and growth determinations (length and weight), as well as endpoints designed to characterize specific endocrine toxicity modes of action targeting oestrogen, androgen or thyroid-mediated physiological processes.
  • 28-July-2015

    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.

  • 28-July-2015

    English

    Test No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)

    This Test Guideline addresses the human health endpoint skin corrosion. It is based on the rat skin transcutaneous electrical resistance (TER) test method, which utilizes skin discs to identify corrosives by their ability to produce a loss of normal stratum corneum integrity and barrier function. This Test Guideline was originally adopted in 2004 and updated in 2015 to refer to the IATA guidance document.
  • 28-July-2015

    English

    Test No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

    This Test Guideline describes an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with the UN Globally Harmonized System of Classification and Labelling (GHS) Category 2.  It is based on reconstructed human epidermis (RhE), which in its overall design closely mimics the biochemical and physiological properties of the upper parts of the human skin. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from tissues. Irritant test substances are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 50% for UN GHS Category 2). Coloured chemicals can also be tested by used of an HPLC procedure. There are three validated test methods that adhere to this Test Guideline. Depending on the regulatory framework and the classification system in use, this procedure may be used to determine the skin irritancy of test substances as a stand-alone replacement test for in vivo skin irritation testing, or as a partial replacement test, within a tiered testing strategy.
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