Oecd Series On Testing And Assessment Guidance Document On The Reporting Of Defined Approaches To Be Used Within Integrated Approaches To Testing And Assessment
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Oecd Series On Testing And Assessment Guidance Document For The Use Of Adverse Outcome Pathways In Developing Integrated Approaches To Testing And Assessment Iata
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2017-03-10
Oecd Series On Testing And Assessment Guidance Document For The Use Of Adverse Outcome Pathways In Developing Integrated Approaches To Testing And Assessment Iata written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-03-10 with categories.
The OECD has been developing guidance documents and tools for the use of alternative methods such as (Q)SAR, chemical categories and Adverse Outcome Pathways (AOPs) as a part of Integrated Approaches for Testing and Assessment (IATA). However, there is a need for a systematic framework to characterise the individual biological and toxicological relevance of alternative methods in assessing chemicals in predicting toxicological endpoints.
Oecd Series On Testing And Assessment Guidance Document On The Reporting Of Defined Approaches To Be Used Within Integrated Approaches To Testing And Assessment
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2017-04-13
Oecd Series On Testing And Assessment Guidance Document On The Reporting Of Defined Approaches To Be Used Within Integrated Approaches To Testing And Assessment written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-13 with categories.
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 ...
Oecd Series On Testing And Assessment Guidance Document On The Reporting Of Defined Approaches And Individual Information Sources To Be Used Within Integrated Approaches To Testing And Assessment Iata For Skin Sensitisation
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2017-07-11
Oecd Series On Testing And Assessment Guidance Document On The Reporting Of Defined Approaches And Individual Information Sources To Be Used Within Integrated Approaches To Testing And Assessment Iata For Skin Sensitisation written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-11 with categories.
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 guidance on the reporting of defined approaches to testing and assessment in the area of skin ...
Oecd Series On Testing And Assessment Guidance Document On Good In Vitro Method Practices Givimp
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2018-12-10
Oecd Series On Testing And Assessment Guidance Document On Good In Vitro Method Practices Givimp written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-10 with categories.
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
Oecd Series On Testing And Assessment Second Edition Guidance Document On Integrated Approaches To Testing And Assessment Iata For Serious Eye Damage And Eye Irritation
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2019-07-25
Oecd Series On Testing And Assessment Second Edition Guidance Document On Integrated Approaches To Testing And Assessment Iata For Serious Eye Damage And Eye Irritation written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-07-25 with categories.
This document suggests an Integrated Approach on Testing and Assessment (IATA) for serious eye damage and eye irritation hazard identification. The document also provides key information characteristics of each of the individual information sources comprising the IATA. Furthermore it provides guidance on how and when to integrate existing and/or newly generated information for decision making, including decisions on the need for further testing or final decisions on classification and labelling regarding the potential eye hazard effects of test chemicals.
Oecd Series On Testing And Assessment Guidance Document On An Integrated Approach On Testing And Assessment Iata For Skin Corrosion And Irritation
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2017-04-13
Oecd Series On Testing And Assessment Guidance Document On An Integrated Approach On Testing And Assessment Iata For Skin Corrosion And Irritation written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-13 with categories.
This Guidance Document proposes an integrated approach on testing and assessment (IATA) for skin corrosion and irritation. It also provides consistent information on key characteristics of each of the individual information sources of the IATA, and relevant guidance on how to integrate ...
Oecd Series On Testing And Assessment Considerations For Assessing The Risks Of Combined Exposure To Multiple Chemicals
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2018-12-06
Oecd Series On Testing And Assessment Considerations For Assessing The Risks Of Combined Exposure To Multiple Chemicals written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-06 with categories.
The report outlines the technical aspects of the various approaches and methodologies available with respect to the assessment of risks from combined exposures to multiple chemicals. The document draws from approaches applied and experience gained in the regulatory context and will therefore be most relevant to the regulatory authorities addressing chemicals, the regulated community and other interested stakeholders.
The History Of Alternative Test Methods In Toxicology
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Author :
language : en
Publisher: Academic Press
Release Date : 2018-10-20
The History Of Alternative Test Methods In Toxicology written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-20 with Medical categories.
The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialized areas, such as inhalation toxicity studies. The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement, Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now-classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialised areas, such as inhalation toxicity studies.
Oecd Series On Testing And Assessment Report On Considerations From Case Studies On Integrated Approaches For Testing And Assessment Iata First Review Cycle 2015 Case Studies On Grouping Methods As A Part Of Iata
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2017-04-13
Oecd Series On Testing And Assessment Report On Considerations From Case Studies On Integrated Approaches For Testing And Assessment Iata First Review Cycle 2015 Case Studies On Grouping Methods As A Part Of Iata written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-13 with categories.
OECD member countries have been making efforts to expand the use of alternative methods in assessing chemicals. The OECD has been developing guidance documents and tools for the use of alternative methods such as (Q)SAR, chemical categories and Adverse Outcome Pathways (AOPs) as a part of ...
Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 442c In Chemico Skin Sensitisation Assays Addressing The Adverse Outcome Pathway Key Event On Covalent Binding To Proteins
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2025-06-25
Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 442c In Chemico Skin Sensitisation Assays Addressing The Adverse Outcome Pathway Key Event On Covalent Binding To Proteins written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-25 with categories.
The present Key Event based 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 is proposed to address the Molecular Initiating Event leading to skin sensitisation, namely protein reactivity, by quantifying the reactivity of test chemicals towards model synthetic peptides or amino acid derivatives containing either lysine or cysteine. This Test Guideline provides three in chemico test methods addressing the same Key Event on the Adverse Outcome Pathway for Skin Sensitisation: (i) the Direct Peptide Reactivity Assay – DPRA, (ii) the Amino Acid Derivative Reactivity Assay – ADRA and (iii) the kinetic Direct Peptide Reactivity Assay – kDPRA. The DPRA and ADRA are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. In contrast, the kDPRA allows discrimination of UN GHS subcategory 1A skin sensitisers from those not categorised as subcategory 1A, i.e. subcategory 1B or no category but does not allow to distinguish sensitisers from non-sensitisers.