By Date


  • 29-July-2016

    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.

  • 29-July-2016

    English

    Test No. 243: Lymnaea stagnalis Reproduction Test

    This Test Guideline is designed to assess effects of prolonged exposure to chemicals on the reproduction and survival of the hermaphrodite freshwater snail Lymnaea stagnalis (the Great Pond Snail). Reproducing adults of L. stagnalis are exposed to a concentration range of the test chemical and monitored for 28 days for their survival and reproduction (number of egg clutches). As additional information, the number of eggs per clutch may also be determined. Adult shell length increase may also be measured. The toxic effect of the test chemical on the cumulated number of clutches produced per individual-day is expressed as ECx by fitting an appropriate regression model to the data in order to estimate the concentration that would cause x% reduction in the reproductive output. Alternatively, the toxic effect of the test chemical can be expressed as the No Observed Effect Concentration and Lowest Observed Effect Concentration (NOEC/LOEC) values. Both ECx and NOEC/LOEC can be determined from a single study.
  • 29-July-2016

    English

    Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test

    This test measures structural chromosomal aberrations (both chromosome- and chromatid-type) in dividing spermatogonial germ cells and is, therefore, expected to be predictive of induction of heritable mutations in these germ cells. The purpose of the in vivo mammalian spermatogonial chromosomal aberration test is to identify those chemicals that cause structural chromosomal aberrations in mammalian spermatogonial cells (1) (2) (3). In addition, this test is relevant to assessing genetoxicity because, although they may vary among species, factors of in vivo metabolism, pharmacokinetics and DNA-repair processes are active and contribute to the response.The original Test Guideline 483 was adopted in 1997. This modified version of the Test Guideline reflects many years of experience with this assay and the potential for integrating or combining this test with other toxicity or genotoxicity studies.
  • 29-July-2016

    English

    Test No. 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

    This Test Guideline describes a method to assess the effects of chemical substances in soil on the reproductive output of the soil mite species Hypoaspis (Geolaelaps) aculeifer Canestrini (Acari: Laelapidae). It can be used for water soluble or insoluble substances, but not with volatile substances.Adult females of similar age are exposed to a range of concentrations of the test substance mixed into 20 g dry mass of artificial soil 28-35 days after the start of the egg laying period. Depending on the endpoint (ECx, NOEC or both), five to twelve concentrations should be tested. At least two to four replicates for each test concentrations and six to eight control replicates, of 10 animals each, are recommended. At 20¡ãC, the test lasts 14 days after introducing the females, which usually allows the control offspring to reach the deutonymph stage. The number of surviving females (mortality ¡Ü 20% for a valid test) and the number of juveniles per test vessel (at least 50 for a valid test) are determined. The fecundity of the mites exposed to the test substance is compared to that of controls in order to determine the ECx (e.g. EC10, EC50) or the No Observed Effect Concentration (NOEC). Any observed differences between the behaviour and the morphology of the mites in the control and the treated vessels should be recorded.
  • 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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    Also AvailableEgalement disponible(s)
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