Latest Documents


  • 5-February-2015

    English

    Test No. 442D: In Vitro Skin Sensitisation - ARE-Nrf2 Luciferase Test Method

    The present Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).

    This Test Guideline (TG) provides an in vitro procedure (the ARE-Nrf2 luciferase test method) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS.

    The second key event on the adverse outcome pathway leading to skin sensitisation takes place in the keratinocytes and includes inflammatory responses as well as gene expression associated with specific cell signalling pathways such as the antioxidant/electrophile response element (ARE)-dependent pathways. The test method described in this Test Guideline (ARE-Nrf2 luciferase test method) is proposed to address this second key event. The cell line contains the luciferase gene under the transcriptional control of a constitutive promoter fused with an ARE element from a gene that is known to be up-regulated by contact sensitisers. The luciferase signal reflects the activation by sensitisers of endogenous Nrf2 dependent genes. This allows quantitative measurement (by luminescence detection) of luciferase gene induction, using well established light producing luciferase substrates, as an indicator of the activity of the Nrf2 transcription factor in cells following exposure to electrophilic test substances.

    Currently, the only in vitro ARE-Nrf2 luciferase test method covered by this Test Guideline is the KeratinoSensTM test method. Performance standards have been developed to enable the validation of similar test methods.

  • 5-February-2015

    English

    Test No. 442C: In Chemico Skin Sensitisation - Direct Peptide Reactivity Assay (DPRA)

    The present Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).

    This Test Guideline provides an in chemico procedure (Direct Peptide Reactivity Assay – DPRA) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS.

    The DPRA is proposed to address the molecular initiating event leading to the skin sensitisation, namely protein reactivity, by quantifying the reactivity of test chemicals towards model synthetic peptides containing either lysine or cysteine. Cysteine and lysine percent peptide depletion values are then calculated and used in a prediction model to categorise a substance in one of four classes of reactivity for supporting the discrimination between skin sensitisers and non-sensitisers.

  • 30-January-2015

    English

    OECD Substitution and Alternatives Assessment Toolbox

    This toolbox is a compilation of resources relevant to chemical substitution and alternatives assessments. Alternative assessments are processes for identifying, comparing and selecting safer alternatives to replace hazardous chemicals with the objective of promoting sustainable production and consumption.

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  • 22-January-2015

    English

    Biosafety and the Environmental Uses of Micro-Organisms

    Micro-organisms play a fundamental role in the environment. Yet their role is the result of complex biogeochemical processes by consortia of micro-organisms and the function of individual species is not clear in many cases. This publication provides an overview of the current situation and relevant developments in environmental microbiology.

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  • 22-January-2015

    English

    Biosafety and the Environmental Uses of Micro-Organisms - Conference Proceedings

    Micro-organisms play a fundamental role in the environment. Yet their role is the result of complex biogeochemical processes by consortia of micro-organisms and the function of individual species is not clear in many cases.

    This publication provides an overview of the current situation and relevant developments in environmental microbiology, as well as its potential application, which covers: use of micro-organisms for agriculture, production purposes, bioremediation, and cleaning purpose; environmental applications of microbial symbionts of insects; and environmental risk/safety assessment of the deliberate release of engineered micro-organisms.

     

  • 15-January-2015

    English

    Addendum Number 2 to the OECD Guiding Principles for Chemical Accident Prevention, Preparedness and Response (2nd ed.) to Address Natural Hazards Triggering Technological Accidents (Natechs)

    An addendum to the OECD Guiding Principles on Chemical Accident Prevention, Preparedness and Response to address Natural Hazards Triggering Technological Accidents (Natech) Risk Management has just been published. The addendum consists of a number of amendments to the Guiding Principles and the addition of a new Chapter to provide more detailed guidance on Natech prevention, preparedness and response.

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  • 13-January-2015

    English

    More about OECD Test Guidelines

    This page explains the background to the OECD Test Guidelines, the reason for their development, their applicability and how they can be accessed.

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  • 9-January-2015

    English

  • 2-January-2015

    English

    Guidance on the GLP Requirements for Peer Review of Histopathology

    The peer review process can lead to changes in the interpretation of the slides and the reported results, and potentially the outcome and conclusions of the study. The purpose of this document is to provide guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented and reported in order to meet GLP expectations and requirements. This document is a complement to the guidance provided in section 3.6.3.7 of OECD Guidance Document 116 (series on testing and assessment), whose focus is on how histopathology peer review should be conducted.

  • 31-December-2014

    English

    System of Environmental Economic Accounting 2012 - Experimental Ecosystems Accounting

    Ecosystem accounting is a relatively new and emerging field dealing with integrating complex biophysical data, tracking changes in ecosystems and linking those changes to economic and other human activity. Considering the increasing demand for statistics on ecosystems within analytical and policy frameworks on environmental sustainability, human well-being and economic growth and development, there has been an increasing urgency to advance this emerging field of statistics.
    Although considerable experience exists in related areas of statistics such as land cover and land use statistics, the integration of these and other information into an ecosystem accounting framework is new. Also, there is considerable existing expertise in the ecosystem sciences and economics fields that is relevant, and again it is the focussing of these different areas of expertise on the proposed ecosystem accounting approach that is new.
    SEEA-Experimental Ecosystem Accounting provides a synthesis of the current knowledge in this area and provides a starting point for the development of ecosystem accounting at national and sub-national levels. It represents an important step forward on ecosystem accounting, providing a common set of terms, concepts, accounting principles and classifications; an integrated accounting structure of ecosystem services and ecosystem condition in both physical and monetary terms; and the recognition of spatial areas as forming the basic focus for measurement.

     

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