Publications


  • 8-September-2009

    English

    Test No. 455: The Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals

    This Test Guideline describes an in vitro assay, which  provides mechanistical information, and can be used for screening and prioritization purposes. The test system utilises the hERalpha-HeLa-9903 cell line derived from a human cervical tumor and stably transfected. This cell line can measure the ability of a test chemical to induce hERalpha-mediated transactivation of luciferase gene expression. The cells are exposed to 7 non-cytotoxic concentrations of the test chemical for 20-24 hours to induce the reporter gene products. Four reference chemicals should be included in each experiment: a strong estrogen (17beta-estradiol), a weak estrogen (17alpha-estradiol), a very weak estrogen (17alpha-methyltestosterone) and a negative control (corticosterone). The activity of the luciferase enzyme is measured in a luminometer. A test chemical is considered to be positive if the maximum response induced is equal to or exceeds 10% of the response of the positive control (1 nM 17alpha-estradiol) in at least two of two or two of three runs.Software to be used with TG 425, 432, 455. Click here. Software not part of the Mutual Acceptance of Data.
  • 8-September-2009

    English

    Test No. 451: Carcinogenicity Studies

    The objective of a long-term carcinogenicity study is to observe test animals for a major portion of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration.

    This Test Guideline is intended primarily for use with rats and mice, and for oral administration. Both sexes should be used. Each dose group and concurrent control group should contain at least 50 animals of each sex. At least three dose levels and a concurrent control should be used. Animals are dosed with the test substance daily (oral, dermal or inhalation administration) and the mode of exposure should be adjusted according to the toxicokinetic profile of the test substance. The duration of the study will normally be 24 months for rodents. For specific strains of mice, duration of 18 months may be more appropriate. Termination of the study should be considered when the number of survivors in the lower dose groups or the control group falls below 25 per cent. The results of these studies include: measurements (weighing, food consumption), and, at least, daily and detailed observations, as well as gross necropsy and histopathology.
  • 8-September-2009

    English

    Test No. 441: Hershberger Bioassay in Rats - A Short-term Screening Assay for (Anti)Androgenic Properties

    The Hershberger Bioassay is an in vivo short–term screening test. It evaluates the ability of a chemical to elicit biological activities consistent with androgen agonists, antagonists or 5 á-reductase inhibitors. The current bioassay is based on the changes in weight of five androgen-dependent tissues in the castrate-peripubertal male rat: the ventral prostate, seminal vesicle (plus fluids and coagulating glands), levator ani-bulbocavernosus muscle, paired Cowper’s glands and the glans penis. In order to establish whether a test substance can have androgenic or antiandrogenic action, two – respectively three - dose groups of the test substance, plus positive and vehicle (negative) controls are normally sufficient. The test substance is administered by gavage or subcutaneous injection daily for 10 consecutive days. To test for antiandrogens, the test substance is administered together with a reference androgen agonist. Each treated and control group should include a minimum of 6 animals.  The animals are necropsied approximately 24 hours after the last administration of the test substance. The tissues are excised and their fresh weights determined.  A statistically significant increase (androgenic) or decrease (antiandrogenic) in the weights of two of the five tissues indicates a positive response in this assay.
  • 8-September-2009

    English

    Test No. 403: Acute Inhalation Toxicity

    This method provides information on health hazard likely to arise from short-term exposure to a test article (gas, vapour or aerosol/particulate test article) by inhalation.

    The revised Test Guideline describes two studies: a traditional LC50 protocol and a Concentration x Time (C x t) protocol. It can be used to estimate a median lethal concentration (LC50), non-lethal threshold concentration (LC01) and slope, and to identify possible sex susceptibility. This Test Guideline enables a test article quantitative risk assessment and classification according to the Globally Harmonized System for the Classification and Labelling of Chemicals. In the traditional LC50 protocol, animals are exposed to one limit concentration or to three concentrations, at least, for a predetermined duration, generally of 4 hours. Usually 10 animals should be used for each concentration. In the C x T protocol, animals are exposed to one limit concentration or a series of concentrations over multiple time durations. Usually 2 animals per C x t interval are used. Animals (the preferred species is the rat) should be observed for at least 14 days. The study includes measurements (including weighing), daily and detailed observations, as well as gross necropsy.
  • 8-September-2009

    English

    Test No. 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants

    The Isolated Chicken Eye  (ICE) test method is an in vitro test method that can be used to classify substances as 'ocular corrosives and severe irritants'. The ICE method uses eyes collected from chickens obtained from slaughterhouses where they are killed for human consumption, thus eliminating the need for laboratory animals. The eye is enucleated and mounted in an eye holder with the cornea positioned horizontally. The test substance and negative/positive controls are applied to the cornea. Toxic effects to the cornea are measured by a qualitative assessment of opacity, a qualitative assessment of damage to epithelium based on fluorescein retention, a quantitative measurement of increased thickness (swelling), and a qualitative evaluation of macroscopic morphological damage to the surface. The endpoints are evaluated separately to generate an ICE class for each endpoint, which are then combined to generate an Irritancy Classification for each test substance.
  • 8-September-2009

    English

    Test No. 509: Crop Field Trial

    Crop field trials are conducted to determine the magnitude of the pesticide residue in or on raw agricultural commodities, including feed items, and should be designed to reflect pesticide use patterns that lead to the highest possible residues.

    Objectives of crop field trials are to: (1) quantify the expected range of residue(s) in crop commodities following treatment according to the proposed or established good agricultural practice; (2) determine, when appropriate, the rate of decline of the residue(s) of plant protection product(s) on commodities of interest; (3) determine residue values such as the 'Supervised Trial Median Residue' and 'Highest Residue' for conducting dietary risk assessment; and (4) derive maximum residue limits (MRLs).  This Test Guideline requires one sample from treated plots at each sampling interval for crops that have eight or more crop field trials.

    The test substance(s) should be stored under appropriate conditions for the study duration and applied soon after preparation or mixing. Test substance applications should not be made in strong wind, during rain or when rainfall is expected shortly after application. For all applications, the application rate should be expressed in terms of amount of product and/or active ingredient per unit area. At the end of each crop field trial, the (stored) samples are analysed for residue level (expressed for example in mg/kg).
  • 8-September-2009

    English

    Test No. 229: Fish Short Term Reproduction Assay

    This Test Guideline describes an in vivo screening assay for fish reproduction where sexually mature male and spawning female fish are held together and exposed to a chemical during a limited part of their life-cycle (21 days). The short term reproduction assay was validated in the fathead minnow (Pimephales promelas) and this is the recommended species. The assay is run with three test chemical concentrations and the necessary controls, including a carrier control if necessary. For the fathead minnow, four replicate test vessels are used for each treatment level and control(s). During the conduct of the assay, the egg production is measured quantitatively daily in each test vessel. At termination of the 21-day exposure period, two biomarker endpoints are measured in males and females separately, as indicators of endocrine activity of the test chemical; these endpoints are vitellogenin and secondary sexual characteristics. Gonads of both sexes are also preserved and histopathology may be evaluated to assess the reproductive fitness of the test animals and to add to the weight of evidence of other endpoints.
  • 8-September-2009

    English

    Test No. 302C: Inherent Biodegradability: Modified MITI Test (II)

    This Test Guideline describes the modified MITI test (II). This test permits the measurement of the Biochemical Oxygen Demand (BOD) and the analysis of residual chemicals in order to evaluate the inherent biodegradability of chemical substances which have been found by the Standard MITI Method (I) to be low degradable.An automated closed-system oxygen consumption measuring apparatus (BOD-meter) is used. Chemicals to be tested are inoculated in the testing vessels (six bottles with different quantities of test chemical) with micro-organisms. In order to check the activity of the inoculum, the use of control substances (aniline, sodium acetate or sodium benzoate) is desirable. During the test period, the BOD is measured continuously. Biodegradability is calculated on the basis of BOD and supplemental chemical analysis, such as measurement of the dissolved organic carbon concentration, concentration of residual chemicals, etc. The BOD curve is obtained continuously and automatically for 14 to 28 days. After the 14 to 28 days of testing, pH, residual chemicals and intermediates in the testing vessels are analysed.
  • 8-September-2009

    English

    Energy Policies of IEA Countries: Portugal 2009

    The International Energy Agency's 2009 review of Portugal's energy policies and programmes.  This edition finds that Portugal has made considerable efforts to strengthen its energy policy since the last IEA in-depth review in 2004. A large number of IEA recommendations have been successfully implemented, including greater diversification of the energy mix and increased energy policy co-ordination. A new National Energy Strategy, published in October 2005, identified three principal means for meeting Portugal’s policy goals: the promotion of renewable energy, increased energy efficiency and competition in energy markets. Over a short period of time, Portugal has become a leader in terms of renewable energy development.  Well-designed incentive mechanisms and the adoption of ambitious targets ensure hydro, wind and other technologies will continue to grow. The National Action Plan for Energy Efficiency was enacted in 2008, and Portugal aims to implement energy efficiency measures equivalent to 9.8% of total final energy consumption by 2015. This plan complements a well developed and co-ordinated climate change policy. Further steps have been taken towards the liberalisation of energy markets, including the innovative creation of a single operator for the transport of natural gas and electricity, natural gas storage and operation of the Sines LNG terminal. Still, a number of challenges remain. Energy markets are not as competitive as policy makers may have wished, and energy research and development policy coordination needs to be strengthened. This review provides sectoral critiques of existing policy and recommendations for further improvements. It is intended to serve as an indispensable guide for Portuguese policy makers as they travel along the path to a more sustainable energy future.
  • 1-September-2009

    English

    Measuring Capital - OECD Manual 2009 - Second edition

    Capital - in particular of the physical sort - plays several roles in economic life: it constitutes wealth and it it provides services in production processes. Capital is invested, disinvested and it depreciates and becomes obsolescent and there is a question how to measure all these dimensions of capital in industry and national accounts. This revised Capital Manual is a comprehensive guide to the approaches toward capital measurement. It gives statisticians, researchers and analysts practical advice while providing theoretical background and an overview of the relevant literature. The manual comes in three parts - a first part with a non-technical description with the main concepts and steps involved in measuring capital; a second part directed at implementation and a third part outlining theory and a more complete mathematical formulation of the measurement process.
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