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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”.
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).
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.
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.
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.
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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This communication outlines the achievements made so far by OECD in addressing the human health and environmental safety implications of manufactured nanomaterials
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.
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.
This document provides the results of an OECD Survey on Integrity of Pesticides at the Manufacturing, Import and Distribution Stages that was carried out in 2009-2010 as part of the OECD pesticide risk reduction activities.