Latest Documents


  • 20-December-2012

    English

    Report of the third OECD Biopesticides Steering Group Seminar on characterisation and analyses of botanicals for the use in plant protection products

    This document presents the outcomes of the 3rd OECD Biopesticide Seminar, held in 2011, that focused on the topic of “botanicals” (also known as plant extracts). The Seminar reviewed a number of scientific and regulatory issues related to the “characterisation and analyses of botanicals for the use in plant protection products”.

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  • 17-December-2012

    English

    Launch of the new OECD Environmental Risk Assessment Toolkit

    The OECD Environmental Risk Assessment Toolkit describes the work flow for environmental risk assessment and management of chemicals with links to available OECD material relevant for the different steps in risk assessment and management. This new version of the Toolkit is more interactive and has added functionalities. It will be populated with additional tools and case studies in the future.

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  • 6-December-2012

    English

    U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs’ Aquatic Life Benchmarks now available on eChemPortal

    The aquatic life benchmarks (for freshwater species) are based on toxicity values reviewed by EPA and used in the Agency's most recent risk assessments developed as part of the decision-making process for pesticide registration. Each Aquatic Life Benchmark is based on the most sensitive, scientifically acceptable toxicity endpoint available for a given taxon of all scientifically acceptable toxicity data available to EPA.

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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, 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. 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. 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.

  • 1-October-2012

    English

    Standard Operating Procedures (SOP) for the OECD Clearing House on New Chemicals Parallel Process

    This document provides detailed guidance for both new chemical notifiers and jurisdictions who wish to participate in a “parallel process” which enables a company to declare to all affected countries at the time of first notification that it wants them to cooperate and share information. The hazard assessment is developed by the ‘lead’ jurisdiction and then utilized by other participating jurisdictions.

  • 12-September-2012

    English

    Consensus Document on the Biology of Cucurbita L. (Squashes, Pumpkins, Zucchinis and Gourds)

    Harmonisation of Regulatory Oversight in Biotechnology Series: the new issue on the biology of Cucurbita L. species (squashes, pumpkins, zucchinis and gourds) is now available. Given the production and use of these vegetable crops worldwide, this document should be of interest for many readers.

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