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  • 27-June-2018

    English

    Test No. 442E: In Vitro Skin Sensitisation - In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation

    The present Key Event based Test Guideline (TG) addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. More specifically, it addresses the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This TG provides three in vitro test methods addressing the same Key Event on the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell Line Activation Test or U-SENS and (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay. All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. Test methods described in this TG either quantify the change in the expression of cell surface marker(s) associated with the process of activation of monocytes and DC following exposure to sensitisers (e.g. CD54, CD86) or the changes in IL-8 expression, a cytokine associated with the activation of DC. In the h-CLAT and U-SENS assays, the changes of surface marker expression are measured by flow cytometry following cell staining with fluorochrome-tagged antibodies. In the IL-8 Luc assay, the changes in IL-8 expression are measured indirectly via the activity of a luciferase gene under the control of the IL-8 promoter. The relative fluorescence or luminescence intensity of the treated cells compared to solvent/vehicle control are calculated and used in the prediction model, to support the discrimination between sensitisers and non-sensitisers.

  • 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. 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

    This Test Guideline describes a cytotoxicity-based in vitro assay that is performed on a confluent monolayer of Statens Seruminstitut Rabbit Cornea (SIRC) cells, cultured on a 96-well polycarbonate microplate. After five-minute exposure to a test chemical, the cytotoxicity is quantitatively measured as the relative viability of SIRC cells using the MTT assay. Decreased cell viability is used to predict potential adverse effects leading to ocular damage. Cell viability is assessed by the quantitative measurement, after extraction from the cells, of blue formazan salt produced by the living cells by enzymatic conversion of the vital dye MTT, also known as Thiazolyl Blue Tetrazolium Bromide. The obtained cell viability is compared to the solvent control (relative viability) and used to estimate the potential eye hazard of the test chemical. A test chemical is classified as UN GHS Category 1 when both the 5% and 0.05% concentrations result in a cell viability smaller than or equal to (≤) 70%. Conversely, a chemical is predicted as UN GHS No Category when both 5% and 0.05% concentrations result in a cell viability higher than (>) 70%.

  • 23-June-2018

    English

    Safety Assessment of Transgenic Organisms in the Environment, Volume 8 - OECD Consensus Document of the Biology of Mosquito Aedes aegypti

    Volume 8 of the Series contains the first biosafety ‘consensus document’ to deal with the biology of an insect, the mosquito Aedes aegypti. Issued by the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology, the science-based consensus documents collate information for use during the regulatory risk assessment of biotechnology products, i.e. transgenic organisms (plants, animals, micro-organisms) when intended for release in the environment. Ae. aegypti mosquito is vectoring yellow fever, dengue, Zika and Chikungunya diseases in tropical and sub-tropical regions worldwide. Biotechnological applications are developed to control the mosquito population and reduce virus transmission. The book provides information on Ae. aegypti taxonomy, morphology, life cycle, reproductive biology, genetics, ecology, interactions with other species and the environment. The mosquito effects on human and animal health, and the control strategies/specific programmes to limit its development are also summarised.

  • 11-June-2018

    English

    Guidance on Change of Ownership in Hazardous Facilities

    The OECD releases a Guidance on Change of Ownership in Hazardous Facilities. This Guidance is a concise document providing a framework to assist stakeholders to identify, understand and minimise the risks during and after a change of ownership at a hazardous facility, and help make the change of ownership a better informed process.

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  • 9-June-2018

    English

    Charlevoix G7 Leaders’ Summit: G7 and Outreach Leaders Working Session

    The preservation of our oceans is indispensable for addressing many of the challenges facing the planet: from food security and climate change to energy provision, and even improved medical care through advanced marine biotechnology.

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  • 6-June-2018

    English

    Economic valuation in 1-Methyl-2-pyrrolidone (NMP) regulation - Environment Working Paper

    This paper gives an overview of economic assessments of the benefits of the control of 1-Methyl-2-pyrrolidone, an organic solvent, used in a number of sectors. Health risks associated with the manufacture of NMP include the risk of stillbirth and developmental retardation to pregnant workers, as well as a variety of chronic and acute effects, including respiratory effects.

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  • 6-June-2018

    English

    Economic assessments of the benefits of regulating mercury - Environment Working Paper

    This paper gives an overview of economic assessments of the benefits of the control of emissions of mercury compounds, their completeness from a social cost point of view and the magnitudes of the values attached to mercury compounds in different contexts. The assessments have been conducted in the context of coal-fired electricity generation and the valuation of human health impacts linked to ingestion of methylmercury.

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  • 6-June-2018

    English

    Socio-economic assessment of phthalates - Environment Working Paper

    This paper gives an overview of economic assessments of the benefits of the control of exposure to phthalates, a group of chemicals with numerous uses, most importantly, as a plasticiser to make rigid plastics like PVC flexible. There is significant concern that these substances can act as endocrine disrupting chemicals (EDCs), affecting both human health and ecosystems.

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  • 6-June-2018

    English

    Economic Valuation in Formaldehyde regulation - Environment Working Paper

    This paper gives an overview of economic assessments of the benefits of the control of formaldehyde and reflects on developments in its risk management and regulation. Formaldehyde is used in the manufacture of resins, as a disinfectant and fixative and as a preservative in consumer products. Formaldehyde exposure can be harmful to human health.

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