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  • 27-juin-2017

    Français

    Essai n° 442B : Sensibilisation cutanée - Essai de stimulation locale des ganglions lymphatiques: BrdU- ELISA

    L’Essai de stimulation locale des ganglions lymphatiques: BrdU-ELISA (ELGL: BrdU-ELISA) est une variante non radioactive de la méthode ELGL qui vise à identifier les substances chimiques sensibilisantes et à mesurer la prolifération lymphocytaire qu’ils induisent dans les ganglions lymphatiques auriculaires. Cette méthode décrite chez la souris  se base sur la quantification de la 5-bromo-2- désoxyuridine (BrdU), un analogue of thymidine, dans l’ADN des lymphocytes, comme indicateur de cette prolifération. Quatre animaux au minimum sont employés par groupe de dose, avec au minimum trois concentrations de la substance d'essai, plus un groupe contrôle négatif traité avec le véhicule seul, et un contrôle positif, au besoin. Le protocole expérimental dure 6 jours. Ensuite, les animaux sont euthanasiés et une suspension unicellulaire de cellules de ganglions lymphatiques (CGL) est préparée. La procédure de dispersion des CGL est une étape cruciale, en particulier pour les ganglions lymphocytaires très petits chez le animaux du groupe contrôle négatif. Ensuite la BrdU dans l’ADN des lymphocytes est quantifiée à l’aide d’un kit de dosage ELISA ou par cytométrie de flux (FCM). L’essai inclut des mesures (pesée, BrdU) et des observations cliniques quotidiennes. Les résultats sont exprimés par l’Indice de Stimulation (IS) obtenu par calcul à partir des indices moyens de marquage BrdU pour les différents groupes. Un SI ≥1.6 pour la méthode ELISA ou un SI ≥2.7 pour la cytométrie de flux justifie l’évaluation de la substance d’essai comme sensibilisant potentiel.
  • 19-June-2017

    English

    Unique Identifier for Transgenic Plants

    The OECD developed the BioTrack Product Database which accommodates Unique Identifiers to each transgenic (or genetically engineered) plant that is approved for commercial use, including planting and food/feed use. These Unique Identifiers are intended to be used as "keys" to access information of each transgenic product in this database and to ensure the safety of modern biotechnology products

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    English

    Fundamental And Guiding Principles For (Q)SAR Analysis Of Chemical Carcinogens with Mechanistic Considerations

    In this document the importance of mechanistic consideration in quantitative structure-activity relationship ((Q)SAR) analysis, the critical role of mechanistic consideration in improving various (Q)SAR approaches and possible integrative approaches of combining chemoinformatics and bioinformatics are discussed, mainly using carcinogenicity as an illustrative toxicity endpoint. The principles and issues described in this document are general and may also be used for various types of chemical assessment. The intended target of readership is for global chemical hazard/risk assessors in regulatory agencies, industries, non-governmental organization and academia who require reliable and scientifically supportable (Q)SAR information and predictions in their assessments as well as for developers/researchers who endeavour to produce scientifically reliable (Q)SAR predictive models and tools.
  • 13-April-2017

    English

    Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment

    With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of the components within IATA. Templates are also provided to enable a structured approach to their documentation in order to facilitate their evaluation. A defined approach to testing and assessment consists of a fixed data interpretation procedure (DIP) applied to data generated with a defined set of information sources to derive a result that can either be used on its own, or together with other information sources within an IATA, to satisfy a specific regulatory need. Thus, a defined approach to testing and assessment can be used to support the hazard identification, hazard characterisation and/or safety assessment of chemicals. This guidance is intended to be used alongside similar guidance aimed at harmonising the reporting of other IATA components such as QSARs, grouping and read-across strategies, and non-guideline in vitro methods.
  • 13-April-2017

    English

    Guidance on Selecting a Strategy for Assessing the Ecological risk of Organometallic and Organic Metal Salt Substances based on their Environmental Fate

    In this document a strategy is presented to facilitate the ecological risk assessment of organometallic compounds (OM) and organic metal salts (OMS), outlining key steps that are based on elucidation of the fate of these substances in the environment. This document puts forth the recommendation that the initial determination of their fate in the environment is a primary factor for deciding how these substances should be assessed recognising that regulatory and program requirements will vary with each jurisdiction.
  • 13-April-2017

    English

    New Scoping Document on in vitro and ex vivo Assays for the Identification of Modulators of Thyroid Hormone Signalling

    This scoping document aims at bringing forward relevant in vitro and ex vivo thyroid assays to the attention of OECD member countries, to provide recommendations for their development/use, and also, to identify aspects/blocks of the thyroid signalling pathways that are not covered and would require further development of thyroid assays. 
  • 13-April-2017

    English

    OECD Guidance for Characterising Hydrocarbon Solvents for Assessment Purposes

    This document presents a harmonized method for characterising, for assessment purposes, a specific subcategory of UVCBs (Substances of Unknown or Variable composition, Complex reaction products or Biological materials): hydrocarbon solvent substances. The method presented in this document gives guidance on how hydrocarbon solvent substances can be characterised in a way that their composition is accurately and consistently reflected. This ensures that substances with the same chemical composition, manufactured in different countries, can be characterised with the same description for hazard assessment purposes. A common understanding and approach to characterising UVCBs would enable regulatory authorities to increase cooperation in the field of hazard assessment and help industry deal with regulatory requirements from multiple jurisdictions.
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    Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation

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  • 13-April-2017

    English

    Corporate governance for process safety - Guidance for senior leaders in high hazard industries

    The Guidance on Corporate Governance for Process Safety draws attention to those at the top of industry to the need for high standards of corporate governance in relation to the management of high hazard industries. The Guidance encourages every director, CEO and President of a major hazard company and to check themselves against a set of self-assessment questions and evaluate their awareness and knowledge in process safety.
  • 13-April-2017

    English

    Report of the Workshop on a Framework for the Development and Use Of Integrated Approaches to Testing and Assessment

    This document is a report of the Workshop on a framework for the development and use of integrated approaches to testing and assessment which was held on 17-19 November 2014 in Crystal City VA, USA. This framework should provide guiding principles, and technical guidance on how results from alternative approaches (in silico, in chemico, in vitro including high throughput and high content test methods) should be interpreted for characterising (both qualitatively and quantitatively) the adverse effects in animals and humans and/ or the environment, so that they can be used for hazard identification, hazard characterisation and risk assessment. The workshop was organised in close cooperation with the World Health Organisation following a proposal from OECD member countries in June 2013. 
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