Latest Documents


  • 29-July-2016

    English

    Test No. 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test

    This screening Test Guideline describes the effects of a test chemical on male and female reproductive performance. It has been updated with endocrine disruptor endpoints, in particular measure of anogenital distance and male nipple retention in pups and thyroid examination.

    The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 63 days. Matings 'one male to one female' should normally be used in this study. This Test Guideline is designed for use with the rat. It is recommended that each group be started with at least 10 animals of each sex. Generally, at least three test groups and a control group should be used. Dose levels may be based on information from acute toxicity tests or on results from repeated dose studies. The test substance is administered orally and daily. The results of this study include clinical observations, body weight and food/water consumption, oestrous cycle monitoring, offspring parameters observation/measurement, thyroid hormone measurement, as well as gross necropsy and histopathology. The findings of this toxicity study should be evaluated in terms of the observed effects, necropsy and microscopic findings. Because of the short period of treatment of the male, the histopathology of the testis and epididymus should be considered along with the fertility data, when assessing male reproductive effects.

  • 29-July-2016

    English

    Test No. 473: In Vitro Mammalian Chromosomal Aberration Test

    The purpose of the in vitro chromosome aberration test is to identify agents that cause structural chromosome aberrations in cultured mammalian somatic cells. Structural aberrations may be of two types: chromosome or chromatid.The in vitro chromosome aberration test may employ cultures of established cell lines, cell strains or primary cell cultures. Cell cultures are exposed to the test substance (liquid or solid) both with and without metabolic activation during about 1.5 normal cell cycle lengths. At least three analysable concentrations of the test substance should be used. At each concentration duplicate cultures should normally be used. At predetermined intervals after exposure of cell cultures to the test substance, the cells are treated with a metaphase-arresting substance, harvested, stained. Metaphase cells are analysed microscopically for the presence of chromosome aberrations.
  • 29-July-2016

    English

    Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes

    The in vitro mammalian cell gene mutation test can be used to detect gene mutations induced by chemical substances. In this test, the used genetic endpoints measure mutation at hypoxanthine-guanine phosphoribosyl transferase (HPRT), and at a transgene of xanthineguanine phosphoribosyl transferase (XPRT). The HPRT and XPRT mutation tests detect different spectra of genetic events.Cells in suspension or monolayer culture are exposed to, at least four analysable concentrations of the test substance, both with and without metabolic activation, for a suitable period of time. They are subcultured to determine cytotoxicity and to allow phenotypic expression prior to mutant selection. Cytotoxicity is usually determined by measuring the relative cloning efficiency (survival) or relative total growth of the cultures after the treatment period. The treated cultures are maintained in growth medium for a sufficient period of time, characteristic of each selected locus and cell type, to allow near-optimal phenotypic expression of induced mutations. Mutant frequency is determined by seeding known numbers of cells in medium containing the selective agent to detect mutant cells, and in medium without selective agent to determine the cloning efficiency (viability). After a suitable incubation time, colonies are counted.
  • 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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