Publications & Documents


  • 9-October-2017

    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.

     

  • 9-October-2017

    English

    Test No. 244: Protozoan Activated Sludge Inhibition Test

    This Test Guideline describes a method to assess effects of a test chemical on the phagocytotic activity of activated sludge containing protozoan organisms under defined conditions in the presence of different concentrations of the test chemical. The principle of biological sewage-treatment plants (STP) is to transform the organic matter of incoming waste-water in microbial biomass, which in turn is separated from the liquid yielding a purified effluent. The purpose of the test is to provide a means to record effects of test chemicals on ciliated protozoa in sewage treatment plants, which due to their grazing on bacteria considerably contribute to the functioning of STPs.
  • 9-October-2017

    English

    Test No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage

    This Test Guideline describes an in vitro procedure allowing the identification of chemicals (substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS. It makes use of reconstructed human cornea-like epithelium (RhCE) which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The test evaluates the ability of a test chemical to induce cytotoxicity in a RhCE tissue construct, as measured by the MTT assay. Coloured chemicals can also be tested by used of an HPLC procedure. RhCE tissue viability following exposure to a test chemical is measured by enzymatic conversion of the vital dye MTT by the viable cells of the tissue into a blue MTT formazan salt that is quantitatively measured after extraction from tissues. The viability of the RhCE tissue is determined in comparison to tissues treated with the negative control substance (% viability), and is then used to predict the eye hazard potential of the test chemical. Chemicals not requiring classification and labelling according to UN GHS are identified as those that do not decrease tissue viability below a defined threshold (i.e., tissue viability > 60%, for UN GHS No Category).

  • 9-October-2017

    English

    Test No. 247: Bumblebee, Acute Oral Toxicity Test

    This test guideline is a laboratory test method, designed to assess the acute oral toxicity of pesticides and other chemicals to adult worker bumblebees.

    Adult worker bumblebees are exposed to 50 % (w/v) aqueous sucrose solution containing the test chemical. The test duration is at least 48 h. Mortality is recorded daily and compared with control values. Results are analysed in order to calculate the LD50 and NOED, if possible, at 24 h & 48 h and furthermore at 72 h & 96 h in case the study is prolonged.

  • 9-October-2017

    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%.

  • 9-October-2017

    English

    Test No. 402: Acute Dermal Toxicity

    This method provides information on health hazard likely to arise from short-term exposure to a test chemical by dermal route. Test chemicals should not be administered at doses that are known to cause marked pain and distress due to potential corrosive or severely irritant actions.

    Groups of animals, of a single sex, are exposed via the dermal route to the test chemical in a stepwise procedure using the appropriate fixed doses. The initial dose level is selected at the concentration expected to produce clear signs of toxicity without causing severe toxic effects or mortality. Further groups of animals may be tested at higher or lower fixed doses, depending on the presence or absence of signs of toxicity or mortality. This procedure continues until the dose causing toxicity or no more than one death is identified, or when no effects are seen at the highest dose or when deaths occur at the lowest dose.  Subsequently, observations of effects and deaths are made. Animals which die during the test are necropsied, and at the conclusion of the test the surviving animals are sacrificed and necropsied.

    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.

     

  • 9-October-2017

    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.

  • 9-October-2017

    English

    Test No. 246: Bumblebee, Acute Contact Toxicity Test

    This test guideline is a laboratory test method, designed to assess the acute contact toxicity of pesticides and other chemicals to adult worker bumblebees.

    Adult worker bumblebees are exposed to the test chemical dissolved in an appropriate carrier, by direct application to the dorsal thorax (droplet). The test duration is at least 48 h. Mortality is recorded daily and compared with control values. Results are analysed in order to calculate the LD50 and NOED, if possible, at 24 h & 48 h and furthermore at 72 h & 96 h in case the study is prolonged.

  • 2-October-2017

    English

    Green investment banks

    To leverage the impact of relatively limited public resources, over a dozen national and sub-national governments have created public green investment banks (GIBs) and GIB-like entities.

    Related Documents
  • 29-September-2017

    English

    Reforming Sanitation in Armenia - Towards a National Strategy

    This report assesses the state of Armenia’s sanitation services, which are in poor shape, and proposes ways forward for reforming the sector by: ensuring equitable access by all and identifying solutions that work for the poorest and most remote communities; generating economies of scale and scope, and reducing both investment and operational costs for the efficient delivery of sanitation services; and moving towards sustainable cost recovery for the sanitation sector, by identifying how much funding can be mobilised from within the sector and how much external transfers are required. The state of Armenia’s sanitation services are inadequate, with 51% of the population in rural areas using unimproved facilities, causing direct damage to the environment and exposing inhabitants to health risks, and better access but degraded sewerage-system infrastructure in urban areas, posing health hazards due to potential cross-contamination between sewage and drinking water. According to preliminary estimates, EUR 2.6 billion of investments will be required to meet Armenia’s sanitation needs, with approximately EUR 1 billion needing to be spent in the next 7 to 10 years. Given the country’s current economic situation, this investment will have to be spread over time and targeted to avoid further deterioration of infrastructure and increase of the financing gap.

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