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  • 20-October-2017

    English

    Section 4: Health Effects

    New deadlines for comments on the Test Guideline 414: Prenatal Developmental Toxicity Study by 24 November 2017.

    Related Documents
  • 13-October-2017

    English

    OECD Guidelines for the Testing of Chemicals

    The OECD Guidelines for the Testing of Chemicals are a collection of the most relevant internationally agreed test methods used by government, industry and independent laboratories to determine the safety of chemicals and chemical preparations, including pesticides and industrial chemicals.

    Related Documents
  • 9-October-2017

    English

    Test No. 405: Acute Eye Irritation/Corrosion

    This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye. This Test Guideline is intended preferably for use with albino rabbit. The test substance is applied in a single dose in the conjunctival sac of one eye of each animal. The other eye, which remains untreated, serves as a control. The initial test uses an animal; the dose level depends on the test substance nature. A confirmatory test should be made if a corrosive effect is not observed in the initial test, the irritant or negative response should be confirmed using up to two additional animals. It is recommended that it be conducted in a sequential manner in one animal at a time, rather than exposing the two additional animals simultaneously. The duration of the observation period should be sufficient to evaluate fully the magnitude and reversibility of the effects observed. The eyes should be examined at 1, 24, 48, and 72 hours after test substance application. The ocular irritation scores should be evaluated in conjunction with the nature and severity of lesions, and their reversibility or lack of reversibility. Use of topical anesthetics and systemic analgesics to avoid or minimize pain and distress in ocular safety testing procedures is described.

  • 9-October-2017

    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.  It was updated in 2017 to enable the testing and characterisation of effects of nanomaterials tested.

    Groups of at least 5 male and 5 female rodents are exposed 6 hours per day for 28 days to a) the test chemical 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), lung burden (LB) for particles, neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test chemical.

  • 9-October-2017

    English

    Test No. 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants

    This Test Guideline describes an in vitro assay that may be used for identifying water soluble ocular corrosives and severe irritants as defined by the UN Globally Harmonized System of Classification and Labelling, Category 1. The assay is performed in a well where a confluent monolayer of Madin-Darby Canine Kidney (MDCK) is used as a separation between two chambers. It uses a fluorescein dye as marqueur. The test substance has the potential to impair the junctions of the MDCK cells and thus to increase the monolayer¡¯s permeability. Consequently the fluorescein passes through the monolayer and the fluorescein leakage (FL) increases. The FL is calculated as a percentage of leakage relative to both a blank control and a maximum leakage control. The concentration of test substance that causes 20% FL (FL20, in mg/mL) is calculated and used in the prediction model for identification of ocular corrosive and severe irritants. The cut-off value of FL20 to identify water soluble chemicals as ocular corrosives/severe irritants is ¡Ü 100mg/mL. The FL test method should be part of a tiered testing strategy.

  • 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. 413: Subchronic Inhalation Toxicity: 90-day Study

    This revised Test Guideline 413 (TG 413) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a period of 90 days, and to provide data for quantitative inhalation risk assessments.  It was updated in 2017 to enable the testing and characterisation of effects of nanomaterials tested.

    Groups of at least 10 male and 10 female rodents are exposed 6 hours per day for 90 days to a) the test chemical 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 chemical. The results of the study include measurement and daily and detailed observations (haematology and clinical chemistry), as well as ophthalmology, gross pathology, organ weights, and histopathology. This Test Guideline allows the flexibility to include satellite (reversibility) groups, interim sacrifices, bronchoalveolar lavage (BAL), lung burden (LB) for particles, neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test chemical.

  • 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. 318: Dispersion Stability of Nanomaterials in Simulated Environmental Media

    This test guideline describes a test procedure to gain information on dispersion stability of manufactured nanomaterials in simulated environmental media. The main purpose of this guideline is to assess the ability of a nanomaterial to attain a colloidal dispersion and to conserve this dispersion under environmentally relevant conditions. The test procedure involves a dispersion of the nanomaterial with the aid of a calibrated sonication procedure and the determination of the mass concentration of the nanomaterial in a set of test vials while the particles undergo homoagglomeration and settling in environments of different hydrochemistry

  • 9-October-2017

    English

    Test No. 245: Honey Bee (Apis Mellifera L.), Chronic Oral Toxicity Test (10-Day Feeding)

    This Test Guideline describes a chronic oral toxicity test on adult worker honey bees under laboratory conditions over an exposure period of 10 days.

    Young bees (max. 2 days old) are exposed to 50 % (w/v) aqueous sucrose solution containing the test chemical by continuous and ad libitum feeding over a period of 10 days. Mortality and behavioural abnormalities are observed and recorded daily during the 10 day test period. The chronic effects of the test chemical are evaluated by comparing the results of the test chemical treated group to those of the respective control group. The test is designed for the determination of the following endpoints  LC50 (median Lethal Concentration) and the LDD50 (median Lethal Dietary Dose) values after 10 days of exposure, and NOEC (No Observed Effect Concentration) and NOEDD (No Observed Effect Dietary Dose).

     

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