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  • 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. 412: Subacute Inhalation Toxicity: 28-Day Study

    This revised Test Guideline 412 (TG 412) has been designed to fully characterize test article toxicity
    by the inhalation route following repeated exposure for a limited period of time (28 days), and to provide data for quantitative inhalation risk assessments.

    Groups of at least 5 male and 5 female rodents are exposed 6 hours per day for 28 days to a) the test article at three or more concentration levels, b) filtered air (negative control), and/or c) the vehicle (vehicle control). Animals are generally exposed 5 days per week but exposure for 7 days per week is also allowed. Males and females are
    always tested, but they may be exposed at different concentration levels if it is known that one sex is
    more susceptible to a given test article. This guideline allows the study director the flexibility to
    include satellite (reversibility) groups, bronchoalveolar lavage (BAL), neurologic tests, and additional
    clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test
    article.

  • 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, Excel, 236kb

    Policy Brief: Cost-effective Actions to Tackle Climate Change

    Governments around the world are working towards an international agreement on actions to achieve large cuts in greenhouse gas emissions at the Fifteenth Conference of the Parties (COP15) under the UN Framework Convention on Climate Change in Copenhagen at the end of 2009. Considering the costs and risks of inaction, taking action now, even in the midst of a global economic crisis, makes good economic sense. This Policy Brief

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  • 4-September-2009

    English

    Incentives for CO2 Emission Reductions in Current Motor Vehicle Taxes

    This paper compares CO2-related tax rate differentiation in motor vehicle taxes in OECD member countries, drawing on information available in the OECD/EEA database on instruments used for environmental policy.

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