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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. 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. 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).
  • 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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  • 11-September-2012

    English, PDF, 3,621kb

    Six Years of OECD Work on The Safety of Manufactured Nanomaterials: Achievements and Future Opportunities

    This communication outlines the achievements made so far by OECD in addressing the human health and environmental safety implications of manufactured nanomaterials

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  • 22-August-2012

    English

    Revised Consensus Document on Compositional Considerations for New Varieties of Soybean [Glycine Max (L.) Merr.]: Key Food and Feed Nutrients, Antinutrients, Toxicants and Allergens

    Novel Food and Feed Series: the revised SOYBEAN document on composition (key nutrients, anti-nutrients, toxicants and allergens) is now available. It replaces the original 2001 document. Given the growing importance of soybean commodities in food and feed worldwide, it should be of interest for many readers.

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  • 9-August-2012

    English

    Guidance Document for Demonstrating Efficacy of Pool and Spa Disinfectants and Field Testing

    This Guidance Document describes how applicants could demonstrate that a proposed new pool and spa disinfectant would satisfy the regulator’s efficacy criteria. While meeting the performance characteristics can be expected to satisfy the regulator’s efficacy requirements, the regulator may choose to consider alternative scientific information and argument aimed at satisfying the efficacy criteria.

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  • 14-April-2011

    English

    OECD activities to assist PRTR implementation

    An overview on OECD activities to assist PRTR implementation, including the aims of the Task Force on PRTRs, as well as information on the dissemination and use of PRTR data and release and estimation techniques.

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