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  • 5-October-2012

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  • 3-October-2012

    English

    Ten new, updated, or corrected Test Guidelines have been adopted by the OECD Council

    The new Test Guidelines are: TG 457 and TG 460. The updated Test Guidelines are TG 109, TG 114, TG 229, TG 211, TG 305, TG 455, and TG 405. The corrected Test Guideline is TG 443

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  • 3-October-2012

    English

    Illegal Trade in Environmentally Sensitive Goods

    Developing effective policies to reduce illegal trade in environmentally sensitive goods requires a clear understanding of what drives this trade and the circumstances under which it thrives, says this report.

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  • 3-October-2012

    English, PDF, 1,097kb

    New Brochure on food, feed and environmental safety of modern biotechnology: available

    This brochure (version: October 2012) presents the activities of the OECD "Working Group on Harmonisation of Regulatory Oversight in Biotechnology" and the "Task Force for the Safety of Novel Foods and Feeds”.

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  • 2-October-2012

    English

    Test No. 457: BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists

    This Test Guideline describes an in vitro assay, which provides concentration-response data for substances with in vitro ER agonist and antagonist activity. The test system utilises the BG1Luc4E2 cell line derived from a human ovarian adenocarcinoma and stably transfected with a ER responsive luciferase reporter gene. This cell line can evaluate TA mediated by ER alpha and ER beta. The cells are plated into 96-well plate and exposed to 7 (range finder tests) and 11 (comprehensive test) non-cytotoxic concentrations of the test chemical for 19-24 hours to induce the reporter gene product (luciferase). Its activity is measured in a luminometer. Acceptance or rejection of a test is based on the evaluation of reference standard and control results from each experiment conducted on a 96-well plate. A positive response is identified by a concentration–response curve containing at least three points with non-overlapping error bars, as well as a change in amplitude (normalized relative light unit) of at least 20 % of the maximal value for the reference substance (17beta-estradiol for the agonist assay, raloxifene HCL/ 17beta-estradiol for the antagonist assay).

  • 2-October-2012

    English

    Test No. 443: Extended One-Generation Reproductive Toxicity Study

    This Test Guideline is designed to provide an evaluation of reproductive and developmental effects that may occur as a result of pre- and postnatal chemical exposure as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring. In the assay, sexually-mature males and females rodents (parental (P) generation) are exposed to graduated doses of the test substance starting 2 weeks before mating and continuously through mating, gestation and weaning of their pups (F1 generation). At weaning, pups are selected and assigned to cohorts of animals for reproductive/developmental toxicity testing (cohort 1), developmental neurotoxicity testing (cohort 2) and developmental immunotoxicity testing (cohort 3). The F1 offspring receive further treatment with the test substance from weaning to adulthood. Clinical observations and pathology examinations are performed on all animals for signs of toxicity, with special emphasis on the integrity and performance of the male and female reproductive systems and the health, growth, development and function of the offspring. Part of cohort 1 (cohort 1B) may be extended to include an F2 generation; in this case, procedures for F1 animals will be similar to those for the P animals.

  • 2-October-2012

    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.

  • 2-October-2012

    English

    Test No. 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure

    This Test Guideline describes a procedure for characterising the bioconcentration potential of substances in fish, using an aqueous (standard and minimised tests) or dietary exposure, under flow-through conditions (but semi-static regimes are permissible). Independent of the chosen exposure method, the bioconcentration fish test test consists of two phases: exposure (uptake) and post-exposure (depuration). During the uptake phase (usually 28 days but can be extended), a group of fish of one species is exposed to the test substances at one or more chosen concentrations (depending on the properties of the test substance). For the depuration phase they are then transferred to a medium free of the test substance, or fed with clean, untreated feed. A depuration phase is always necessary unless uptake of the substance during the uptake phase has been insignificant. In addition to the test concentration, a control group of fish is held without the test substance. The minimised aqueous exposure test is not run over a shorter period than the standard test but comprises less fish sampling. The dietary exposure bioconcentration fish test is used for substances where the aqueous exposure methodology is not practicable. In the three test methods the concentration of the test substance in the fish is followed through both phases of the test: the aqueous exposure test yields a bioconcentration factor (BCF) and the dietary approach yields a biomagnifications factor (BMF); greater emphasis is put on kinetic BCF estimation (when possible) next to estimating the BCF at steady state. BCF and BMF are expressed based on the total concentration in fish, i.e. per total wet weight of the fish, and as normalized to a fish with a 5% lipid content.

  • 2-October-2012

    English

    Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists

    This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provides the methodology of Stably Transfected Transactivation to detect Estrogen Receptor Agonists (ER TAs). It comprises mechanistically and functionally similar test methods for the identification of estrogen receptor agonists and should facilitate the development of new similar or modified test methods. The two reference test methods that provide the basis for this PBTG are: the Stably Transfected TA (STTA) assay using the (h) ERá-HeLa-9903 cell line, derived from a human cervical tumor, and the BG1Luc ER TA assay using the BG1Luc-4E2 cell line, derived from a human ovarian adenocarcinoma. The cell lines used in these assays express ER and have been stably transfected with an ER responsive luciferase reporter gene. The assays are used to identify chemicals that activate the ER following ligand binding, after which the receptor-ligand complex binds to specific DNA response elements and transactivates the reporter gene, resulting in increased cellular expression of a marker enzyme (e.g. luciferase in luciferase based systems). The enzyme then transforms the substrate to a bioluminescent product that can be quantitatively measured with a luminometer.These test methods are being proposed for screening and prioritisation purposes, but also provide mechanistic information that can be used in a weight of evidence approach.

  • 2-October-2012

    English

    Test No. 114: Viscosity of Liquids

    This Test Guideline describes methods to measure the viscosity of liquids. Most of the methods listed are appropriate for the investigation of Newtonian liquids. The measurement of non-Newtonian liquids is possible with the rotational viscometer. Viscosity measurements are carried out according to five methods: the capillary viscometer, the flow cup, the rotational viscometer, the rolling ball viscometer and the drawing ball viscometer. Each determination of viscosity should be made at a temperature of 20°C and at 40°C. At least two determinations should be made at each temperature. The viscosity measurement is to be carried out according to the standards in the case of capillary and forced ball viscometers. In the case of rotational viscometers, the specification of a viscosity is appropriate only for Newtonian fluids. For non- Newtonian fluids, the results obtained are preferred in table or graph form, preferably in the order of increasing shear rate.

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