Oecd Series On Testing And Assessment Guidance Document On Good In Vitro Method Practices Givimp

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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 ...

Guidance Document On Good In Vitro Method Practices Givimp

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Author : Organisation for Economic Co-operation and Development
language : en
Publisher:
Release Date : 2018

Guidance Document On Good In Vitro Method Practices Givimp written by Organisation for Economic Co-operation and Development and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 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 data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.

Oecd Series On Testing And Assessment Revised Guidance Document 150 On Standardised Test Guidelines For Evaluating Chemicals For Endocrine Disruption

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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2018-09-03

Oecd Series On Testing And Assessment Revised Guidance Document 150 On Standardised Test Guidelines For Evaluating Chemicals For Endocrine Disruption 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 2018-09-03 with categories.

This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.

Practical Handbook On The 3rs In The Context Of The Directive 2010 63 Eu

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Author : Gianni Dal Negro
language : en
Publisher: Academic Press
Release Date : 2021-11-18

Practical Handbook On The 3rs In The Context Of The Directive 2010 63 Eu written by Gianni Dal Negro and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-18 with Science categories.

Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU provides updated information on the EU Directive 2010/63/EU, which is the European Union legislation that protects animals being used in research. EU Directive 2010/63/EU is the European Union (EU) legislation 'on the protection of animals used for scientific purposes' and is one of the most stringent ethical and welfare standards worldwide. - Closes a gap in scientific literature by addressing the need for clear guidance in walking through the multifaced universe of 3Rs - Offers a useful starting point for readers and scientist who approach the 3Rs for the first-time - Gives insights into the harmonization of the animal research legislation across countries

Organotypic Models In Drug Development

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Author : Monika Schäfer-Korting
language : en
Publisher: Springer Nature
Release Date : 2021-03-25

Organotypic Models In Drug Development written by Monika Schäfer-Korting and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-25 with Medical categories.

This book provides latest findings in organotypic models in drug development and provides the scientific resonance needed in an emerging field of research in disciplines, such as molecular medicine, physiology, and pathophysiology. Today the research on human-based test systems has gained major interest and funding in the EU and the US has increased over the last years. Moreover, so-called 3R (reduce, replace, refine animal experiments) centres have been established worldwide.

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 442e In Vitro Skin Sensitisation In Vitro Skin Sensitisation Assays Addressing The Key Event On Activation Of Dendritic Cells On The Adverse Outcome Pathway For Skin Sensitisation

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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2024-06-25

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 442e In Vitro Skin Sensitisation In Vitro Skin Sensitisation Assays Addressing The Key Event On Activation Of Dendritic Cells On The Adverse Outcome Pathway 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 2024-06-25 with categories.

The present Key Event based Test Guideline (TG) 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 TG is proposed to address the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. It provides four in vitro test methods addressing the same Key Event on the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell Line Activation Test or U-SENS, (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay and (iv) the Genomic Allergen Rapid Detection for assessment of skin sensitisers (GARDTMskin). All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The test methods described in this TG either quantify the change in the expression of cell surface marker(s) CD54 and CD86, the cytokine IL-8, or a series of genes (genomic biomarker signature) that are associated with the process of activation of monocytes and DC following exposure to sensitisers.

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 444a In Vitro Immunotoxicity Il 2 Luc And Il 2 Luc Ltt Assays

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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 444a In Vitro Immunotoxicity Il 2 Luc And Il 2 Luc Ltt Assays 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.

This Test Guideline (TG) describes the IL-2 Luc Assay test method to evaluate the potential immunotoxic effects of chemicals on T lymphoblastic cell line. This cell line allows quantitative measurement of luciferase gene induction by detecting luminescence from well-established light producing luciferase substrates as indicators of the activity of IL-2, IFN-γ and GAPDH in cells following exposure to immunotoxic chemicals.

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 494 Vitrigel Eye Irritancy Test Method For Identifying Chemicals Not Requiring Classification And Labelling For Eye Irritation Or Serious Eye Damage

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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2021-06-17

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 494 Vitrigel Eye Irritancy Test Method For Identifying Chemicals Not Requiring Classification And Labelling For Eye Irritation Or Serious Eye Damage 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 2021-06-17 with categories.

The Vitrigel-Eye Irritancy Test (EIT) method is an in vitro test method that allows the identification of test chemicals not requiring classification and labelling for eye irritation or serious eye damage. This test measures the eye irritation potential of a test chemical based on its ability to induce damage to the barrier function of the human corneal epithelium (hCE) models used in the Vitrigel-EIT method. It is known that chemicals that are irritating to the eye first destroy tear film and epithelial barrier function of the eye, subsequently induce epithelial cell death, and finally produce stromal degeneration and endothelial cell death, resulting in corneal opacity. Therefore, the change of the epithelial barrier function is a relevant endpoint for detecting eye irritation. In the Vitrigel Eye Irritancy test method , time-dependent changes in the Transepithelial Electrical Resistance (TEER) values are indicative of damage to the barrier function of the corneal epithelium following exposure to a test chemical; this situation is similar to the observed damage of the rabbit cornea following exposure to a test chemical, which is an important mode of action leading to damage of the corneal epithelium and eye irritation. The Vitrigel-Eye Irritancy Test (EIT) method can be used within the limited applicability domain of test chemicals having pH > 5.0 (based on 2.5% weight/volume (w/v) preparation).

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 458 Stably Transfected Human Androgen Receptor Transcriptional Activation Assay For Detection Of Androgenic Agonist And Antagonist Activity Of Chemicals

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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2023-07-04

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 458 Stably Transfected Human Androgen Receptor Transcriptional Activation Assay For Detection Of Androgenic Agonist And Antagonist Activity Of 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 2023-07-04 with categories.

This Test Guideline describes in vitro assays, which use Androgen Receptor TransActivation (ARTA) to detect Androgen Receptor Agonists and Antagonists. The ARTA assay methods are mechanistically and functionally similar test methods that provide information on the transcription and translation of a reporter gene following the binding of a chemical to the androgen receptor and subsequent transactivation.

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 432 In Vitro 3t3 Nru Phototoxicity Test

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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2004-11-23

Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 432 In Vitro 3t3 Nru Phototoxicity Test 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 2004-11-23 with categories.

This Test Guideline describes a method to evaluate photo-cytotoxicity by the relative reduction in viability of cells exposed to the chemical in the presence versus absence of light. Balb/c 3T3 cells are maintained in culture for 24 h for formation ...