OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)

OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)

Author: OECD

Publisher: OECD Publishing

Published: 2018-12-10

Total Pages: 206

ISBN-13: 9264304797

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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 ...


Book Synopsis OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) by : OECD

Download or read book OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) written by OECD and published by OECD Publishing. This book was released on 2018-12-10 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)

Guidance Document on Good In Vitro Method Practices (GIVIMP)

Author: Organisation for Economic Co-operation and Development

Publisher:

Published: 2018

Total Pages: 172

ISBN-13: 9789264311008

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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.


Book Synopsis Guidance Document on Good In Vitro Method Practices (GIVIMP) by : Organisation for Economic Co-operation and Development

Download or read book Guidance Document on Good In Vitro Method Practices (GIVIMP) written by Organisation for Economic Co-operation and Development and published by . This book was released on 2018 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.


Guidance Document on Good In Vitro Method Practices (GIVIMP)

Guidance Document on Good In Vitro Method Practices (GIVIMP)

Author: Organisation for Economic Co-operation and Development

Publisher:

Published: 2018

Total Pages: 172

ISBN-13: 9789264311015

DOWNLOAD EBOOK

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.


Book Synopsis Guidance Document on Good In Vitro Method Practices (GIVIMP) by : Organisation for Economic Co-operation and Development

Download or read book Guidance Document on Good In Vitro Method Practices (GIVIMP) written by Organisation for Economic Co-operation and Development and published by . This book was released on 2018 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Guidance Document for Describing Non-Guideline In Vitro Test Methods

OECD Series on Testing and Assessment Guidance Document for Describing Non-Guideline In Vitro Test Methods

Author: OECD

Publisher: OECD Publishing

Published: 2017-04-13

Total Pages: 17

ISBN-13: 9264274731

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The purpose of this guidance is to harmonise the way non-guideline in vitro methods are described and thereby facilitate an assessment of the relevance of test methods for biological activities and responses of interest, and an assessment of the quality of data produced, irrespective of whether ...


Book Synopsis OECD Series on Testing and Assessment Guidance Document for Describing Non-Guideline In Vitro Test Methods by : OECD

Download or read book OECD Series on Testing and Assessment Guidance Document for Describing Non-Guideline In Vitro Test Methods written by OECD and published by OECD Publishing. This book was released on 2017-04-13 with total page 17 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this guidance is to harmonise the way non-guideline in vitro methods are described and thereby facilitate an assessment of the relevance of test methods for biological activities and responses of interest, and an assessment of the quality of data produced, irrespective of whether ...


OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Conduct of Skin Absorption Studies

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Conduct of Skin Absorption Studies

Author: OECD

Publisher: OECD Publishing

Published: 2004-11-01

Total Pages: 31

ISBN-13: 9264078797

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This guidance document has been prepared to support technical aspects of the OECD skin absorption test guidelines. In particular is discusses the various aspects of in vivo vs. in vitro testing.


Book Synopsis OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Conduct of Skin Absorption Studies by : OECD

Download or read book OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Conduct of Skin Absorption Studies written by OECD and published by OECD Publishing. This book was released on 2004-11-01 with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance document has been prepared to support technical aspects of the OECD skin absorption test guidelines. In particular is discusses the various aspects of in vivo vs. in vitro testing.


OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Development of OECD Guidelines for Testing of Chemicals

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Development of OECD Guidelines for Testing of Chemicals

Author: OECD

Publisher: OECD Publishing

Published: 2002-05-10

Total Pages: 28

ISBN-13: 9264077928

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This Monograph describes in detail the process of Test Guideline development, including the structure of the Test Guidelines Programme, the responsibilities of those involved and the procedures which should be followed.


Book Synopsis OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Development of OECD Guidelines for Testing of Chemicals by : OECD

Download or read book OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Development of OECD Guidelines for Testing of Chemicals written by OECD and published by OECD Publishing. This book was released on 2002-05-10 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Monograph describes in detail the process of Test Guideline development, including the structure of the Test Guidelines Programme, the responsibilities of those involved and the procedures which should be followed.


OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Human Endpoints for Experimental Animals Used in Safety Evaluation

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Human Endpoints for Experimental Animals Used in Safety Evaluation

Author: OECD

Publisher: OECD Publishing

Published: 2002-05-10

Total Pages: 39

ISBN-13: 9264078371

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The purpose of this Guidance Document is to apply the principles of the Three Rs to the use of animals in regulatory toxicity tests.


Book Synopsis OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Human Endpoints for Experimental Animals Used in Safety Evaluation by : OECD

Download or read book OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Human Endpoints for Experimental Animals Used in Safety Evaluation written by OECD and published by OECD Publishing. This book was released on 2002-05-10 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this Guidance Document is to apply the principles of the Three Rs to the use of animals in regulatory toxicity tests.


OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

Author: OECD

Publisher: OECD Publishing

Published: 2018-09-03

Total Pages: 692

ISBN-13: 9264304746

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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.


Book Synopsis OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption by : OECD

Download or read book OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption written by OECD and published by OECD Publishing. This book was released on 2018-09-03 with total page 692 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU

Author: Gianni Dal Negro

Publisher: Academic Press

Published: 2021-11-18

Total Pages: 348

ISBN-13: 0128212527

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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


Book Synopsis Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU by : Gianni Dal Negro

Download or read book Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU written by Gianni Dal Negro and published by Academic Press. This book was released on 2021-11-18 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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


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

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

Author: OECD

Publisher: OECD Publishing

Published: 2024-06-25

Total Pages: 91

ISBN-13: 9264264353

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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.


Book Synopsis 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 by : OECD

Download or read book 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 published by OECD Publishing. This book was released on 2024-06-25 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.