Latest Documents


  • 29-July-2016

    English

    Test No. 489: In Vivo Mammalian Alkaline Comet Assay

    The in vivo alkaline single cell gel electrophoresis assay, also called alkaline Comet Assay is a method measuring DNA strand breaks in eukaryotic cells.

    Each treated group is composed of a minimum of 5 animals of one sex (or of each sex as appropriate). A positive and a vehicle control group are also used. Administration of the treatment consists of daily doses over duration of 2 days or more, ensuring the test chemical reaches the target tissue which can be the liver, the kidney or other tissues if justified.

    Tissues of interest are dissected and single cells/nuclei suspensions are prepared and embedded in agarose on slides. Cells/nuclei are treated with lysis buffer to remove cellular and/or nuclear membranes. The nuclear DNA in the agar is then subjected to electrophoresis at high pH. This results in structures resembling comets which by using suitable fluorescent stain, can be observed by fluorescent microscopy. Based on their size DNA fragments migrate away from the head to the tail, and the intensity of the comet tail relative to the total intensity (head plus tail) reflects the amount of DNA breakage.

  • 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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  • 31-May-2016

    English

    German database Information system für gefährliche Stoffe IGS

    German database Information system für gefährliche Stoffe IGS is now linked to eChemPortal. The IGS provides public access to a variety of information on chemical and microbiological substances mostly in German. The focus is on regulatory information reflecting German and European, as well as Swiss, US and selected other legislation and assessments. Beside this, information on substance data and emergency procedures is available.

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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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  • 5-April-2016

    English

    Safety Assessment of Transgenic Organisms in the Environment, Volume 5 - OECD Consensus Documents

    This series represents a compilation of the biosafety consensus documents developed by the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology over the periods 2011-12 (Volume 5) and 2013-15 (Volume 6). Volumes 5 and 6 describe the biology, centres of origin, genetics, hybridisation, production and use, and ecology elements of several crops (sugarcane, cassava, sorghum, common bean, cucurbits) and trees (eucalyptus species). They also provide considerations on pathogenicity factors in assessing the potential adverse health effects of bacteria, and the low level presence of transgenic plants in seed and grain commodities.
    The consensus documents contain information for use during the regulatory assessment of products of modern biotechnology, i.e. transgenic organisms (plants, animals, micro-organisms), when intended for release in the environment. As such, it should be of value to applicants for use of genetically-engineered organisms in agriculture mainly, to regulators and risk assessors in national authorities for their biosafety assessments, as well as the wider scientific community. More information on this OECD programme is found at BioTrack online (www.oecd.org/biotrack).

     

  • 5-April-2016

    English

    Safety Assessment of Transgenic Organisms in the Environment, Volume 6 - OECD Consensus Documents

    This series represents a compilation of the biosafety consensus documents developed by the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology over the periods 2011-12 (Volume 5) and 2013-15 (Volume 6). Volumes 5 and 6 describe the biology, centres of origin, genetics, hybridisation, production and use, and ecology elements of several crops (sugarcane, cassava, sorghum, common bean, cucurbits) and trees (eucalyptus species). They also provide considerations on pathogenicity factors in assessing the potential adverse health effects of bacteria, and the low level presence of transgenic plants in seed and grain commodities.
    The consensus documents contain information for use during the regulatory assessment of products of modern biotechnology, i.e. transgenic organisms (plants, animals, micro-organisms), when intended for release in the environment. As such, it should be of value to applicants for use of genetically-engineered organisms in agriculture mainly, to regulators and risk assessors in national authorities for their biosafety assessments, as well as the wider scientific community. More information on this OECD programme is found at BioTrack online (www.oecd.org/biotrack).
     

  • 24-March-2016

    English

    Series on Pesticides

    New pesticides guidance has been finalised that harmonises the way terrestrial field dissipation studies (TFDs) are conducted in different regions of the world.

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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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  • 1-March-2016

    English

    Series on Pesticides

    New pesticides guidance has been finalised that harmonises the way terrestrial field dissipation studies (TFDs) are conducted in different regions of the world.

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    Also AvailableEgalement disponible(s)
  • 18-February-2016

    English

    Pesticides: Risk Indicators

    New report describes OECD's on-line Pesticide Risk Indicators (PRIs) database, and how it can be used. The database includes information on existing PRIs which are used by governments to track trends in risk resulting from the use of agricultural pesticides. The report summarises information on each indicator in the database, including the purpose of the indicator, requirements for data input, user friendliness and additional features.

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