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Front Cover
The History of Alternative Test Methods in Toxicology
The History of Alternative Test Methods in Toxicology
Copyright
Contents
Contributors
Biographical Notes
CO-EDITORS
CO-AUTHORS
Preface to the Series
Preface for The History of Alternative Test Methods in Toxicology
1 - Setting the Scene
1.1 - The Introduction and Influence of the Concept of Humane Experimental Technique
1. INHUMANITY AND THE THREE RS CONCEPT
2. PROGRESS FOLLOWING THE PUBLICATION OF THE PRINCIPLES
3. ALTERNATIVES
4. PROGRESS IN THE 1980S
5. INTO THE 1990S
REFERENCES
1.2 - Types of Toxicity and Applications of Toxicity Testing
1. THE NEED FOR TESTING
2. TYPES OF TOXICITY TEST
3. APPLICATIONS OF TOXICITY TESTING
4. RISK MANAGEMENT
5. THE REPLACEMENT OF ANIMAL TESTS
6. CONCLUSIONS
REFERENCES
1.3 - The Key Technologies
1. INTRODUCTION
2. TECHNOLOGY DRIVERS
2.1 Tissue Culture Systems
2.2 Reporter Gene Assays and Biosensors
2.3 Miniaturised and Large-Scale Culture Systems
2.4 Toxicogenomics and Proteomics
2.5 Other Enabling Technologies
3. DISCUSSION AND CONCLUSIONS
REFERENCES
2 - Contributions From Countries, Regions and Organisations
2.1 - Alternative Methods in Toxicity Testing in the UK
1. EARLY DAYS
2. THE FUND FOR THE REPLACEMENT OF ANIMALS IN MEDICAL EXPERIMENTS
3. THE NATIONAL CENTRE FOR THE THREE RS
4. OTHER ORGANISATIONS
REFERENCES
2.2 - Contributions From the German-Speaking Countries
1. INTRODUCTION
2. CONTRIBUTIONS FROM SWITZERLAND
2.1 The Foundation Research 3R
2.2 The Swiss Institute for Alternatives to Animal Testing
2.3 The Fondation Egon Naef Pour la Recherche In Vitro
2.4 Swiss Governmental Agency Support for the Three Rs Concept
3. CONTRIBUTIONS FROM GERMANY.
3.1 Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergaenzungsmethoden zum Tierversuch (ZEBET)
3.2 Reducing Animal Numbers in Regulatory Toxicity Testing
3.3 The Regulatory Acceptance of In Vitro Toxicity Tests Successfully Validated at ZEBET
3.4 The Funding of Research on In Vitro Toxicity Testing in Germany
3.5 ZEBET's Wider Activities
4. CONTRIBUTIONS FROM AUSTRIA
5. CONCLUSIONS
REFERENCES
2.3 - Contributions to Alternatives From Italy and Spain
1. ACTIVITIES IN ITALY RELATED TO ALTERNATIVE METHODS
1.1 The Italian Association for In Vitro Toxicology
1.2 The Italian National Platform for Alternative Methods
1.3 The Italian National Reference Centre
1.4 The Three Rs Declaration of Bologna
2. ACTIVITIES IN SPAIN RELATED TO IN VITRO PHARMACOTOXICOLOGY
2.1 The ICLAS/CSIC Working Group on Complementary Methods
2.2 The Spanish Working Group on Alternative Methods
2.3 The 3ERRES Mailing List on Alternatives
2.4 Spanish Scientific Productivity Related to In Vivo and In Vitro Alternative Methods
2.5 The Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the Use of Laboratory Animals
2.6 The Spanish Network for the Development of Alternative Methods
REFERENCES
2.4 - Contributions to Alternatives From The Netherlands, Belgium and France
1. DEVELOPMENT OF ALTERNATIVES TO TOXICITY TESTING IN THE NETHERLANDS
1.1 Early Years
1.2 Recent Technological Developments
1.3 Organisational Frameworks
1.3.1 National Initiatives
1.3.2 International Initiatives
1.4 Implementation of Alternatives
1.5 Conclusions
2. DEVELOPMENT OF ALTERNATIVES TO TOXICITY TESTING IN BELGIUM
2.1 Early Years
2.2 More-recent Three Rs Developments in Belgium
3. DEVELOPMENT OF ALTERNATIVES TO TOXICITY TESTING IN FRANCE
3.1 Early Years.
3.2 Recent Technological Developments
3.3 Organisational Frameworks
3.4 Implementation of Alternatives
3.5 Conclusions
REFERENCES
2.5 - Contributions of the Scandinavian Countries to the Development of Non-Animal Alternatives in Toxicology
1. INTRODUCTION
2. THE DEVELOPMENT AND USE OF ALTERNATIVE IN VITRO METHODS
2.1 Cell Toxicology
2.2 Neurotoxicology
2.3 Ocular Toxicology
2.4 Tissue Modelling
2.5 Reproductive Toxicology
2.6 Toxicokinetics and Biotransformation Modelling
2.7 Genotoxicity and Carcinogenicity Testing In Vitro
2.8 Ecotoxicology
2.9 Skin Sensitisation
3. ALTERNATIVES IN INDUSTRY
4. FINANCING RESEARCH ON NON-ANIMAL ALTERNATIVES, 1980-2016
5. RESEARCH CENTRES ESTABLISHED FOR THE DEVELOPMENT AND VALIDATION OF NON-ANIMAL METHODS
6. EDUCATION AND NON-ANIMAL METHODS
7. CONCLUDING COMMENTS
ACKNOWLEDGEMENTS
REFERENCES
2.6 - The Three Rs and Alternatives in the VisegrAd (V4) Countries
1. CENTRAL EUROPEAN COUNTRIES JOIN WESTERN EUROPEAN COUNTRIES IN THE EU
2. INITIAL THREE RS DEVELOPMENTS IN CZECHOSLOVAKIA
3. THREE RS ACTIVITIES IN THE CZECH REPUBLIC
3.1 The TEMPUS Joint European Project
3.2 World Congresses on Alternatives
3.3 Visit of Professor William Russell in 1997
3.4 Alternatives Conference in Prague, 2001
3.5 SSCT Meeting, 2009
3.6 Major Collaborations
3.7 Government Organisations
3.8 The State Veterinary Administration
4. ACTIVITIES IN SLOVAKIA
4.1 Early Developments in Slovakia
4.2 The National Scientific Network on Alternative Methods
4.3 The Slovak Toxicology Society
4.4 Interdisciplinary Toxicology
4.5 The State Veterinary and Food Administration of the Slovak Republic
4.6 The Private Sector
4.7 International Collaboration
5. ACTIVITIES IN HUNGARY
5.1 Organisations
5.2 Governmental Institutions.
5.3 The Private Sector
5.4 International Collaborations
5.5 Journal
6. THREE RS DEVELOPMENTS IN POLAND
6.1 Animal Experimentation in Poland
6.2 The Promotion of Alternatives
6.3 International Scientific Collaboration
6.4 Concluding Comment
REFERENCES
2.7 - Australia and New Zealand
1. INTRODUCTION
2. THE 1989 AUSTRALIAN SENATE REPORT
3. LOCAL FACTORS
3.1 The Australian Anti-Venom Industry
3.2 Facial Eczema in Sheep
4. PARALYTIC SHELLFISH TOXIN
5. ENVIRONMENTAL MONITORING
6. COSMETICS TESTING
7. ORGANISATIONS
8. CURRENT REGULATORY INTEREST
9. DISCUSSION AND CONCLUSIONS
REFERENCES
2.8 - Japanese Contributions to the Development of Alternative Test Methods
1. THE JAPANESE SOCIETY FOR ALTERNATIVES TO ANIMAL EXPERIMENTS
1.1 JSAAE Activities
1.2 International Cooperation
1.3 What Is Next for the JSAAE?
2. THE BACKGROUND TO JACVAM
2.1 What Is JaCVAM's Role?
2.2 Regulatory Acceptance and Ongoing Studies
REFERENCES
2.9 - Contributions to the Development of Alternatives in Toxicology in China and Brazil
1. INTRODUCTION: ALTERNATIVES IN CHINA AND BRAZIL
2. ALTERNATIVES IN CHINA
2.1 History of Animal Use Regulations in China
2.2 The Regulatory Framework in China
2.3 Movement Toward the Use and Validation of Alternative Methods in China
2.4 Support for, and Regulatory Implementation of, Alternatives Within China
2.5 Special Difficulties or Hurdles to Accepting and/or Using Alternative Methods
2.6 Future Outlook for Alternatives in China
3. ALTERNATIVES IN BRAZIL
3.1 History of Animal Use Regulations in Brazil
3.2 The Regulatory Framework in Brazil
3.3 Movement Toward the Use and Validation of Alternative Methods in Brazil
3.4 Support for, and Regulatory Implementation of, Alternatives Within Brazil.
3.5 Special Difficulties or Hurdles to Accepting and/or Using Alternative Methods
3.6 Future Outlook for Alternatives in Brazil
REFERENCES
2.10 - The Role of ECVAM
1. THE EARLY YEARS OF ECVAM, 1991-2002
1.1 Validation
1.2 Workshops and Task Forces
1.3 Biologicals
1.4 In-house Research
1.5 Collaboration in Education and Training
1.6 The ECVAM Scientific Information Service
1.7 Collaborations
1.8 Summary
2. THE EVOLUTION OF ECVAM AND ITS NETWORKS
3. ECVAM ACTIVITIES IN THE CONTEXT OF EU POLICY DRIVERS FOR ALTERNATIVES
3.1 EU Legislation on Cosmetic Products
3.2 The EU Chemicals Policy - REACH
3.3 Other EU Chemicals Policies Relevant to Alternatives
3.4 The European Citizens' Initiative `Stop Vivisection'
4. ECVAM'S CONTRIBUTIONS TO INTERNATIONAL HARMONISATION ACTIVITIES WITHIN THE OECD
4.1 OECD Projects of the TGs Programme Currently (Co-)led by ECVAM
4.2 Activities of ECVAM in the OECD Extended Advisory Group for Molecular Screening and Toxicogenomics
4.3 Activities of ECVAM in the OECD Working Party on Hazard Assessment
5. FUTURE OUTLOOK
REFERENCES
2.11 - The Center for Alternatives to Animal Testing in the USA and Europe
1. CAAT‒USA
2. CAAT‒EUROPE
3. THE CAAT PROGRAMMES
3.1 The Grants Programme
3.2 The Avon Programme Project
3.3 The Communications Programme
3.4 Workshops and Technical Reports - The t4 Programme
3.5 Education Programmes
3.6 The Refinement Programme
3.7 US and EU Policy Programmes
4. FROM A SYMPOSIUM SERIES TO WORLD CONGRESSES
5. TOXICOLOGY TESTING IN THE 21ST CENTURY - THE HUMAN TOXOME PROJECT
6. THE EVIDENCE-BASED TOXICOLOGY COLLABORATION
7. THE GREEN TOXICOLOGY COLLABORATION
8. THE READ-ACROSS PRACTICE COLLABORATION
9. THE GOOD CELL CULTURE PRACTICE COLLABORATION
ACKNOWLEDGEMENTS
REFERENCES.
2.12 - USA: ICCVAM and NICEATM.
The History of Alternative Test Methods in Toxicology
The History of Alternative Test Methods in Toxicology
Copyright
Contents
Contributors
Biographical Notes
CO-EDITORS
CO-AUTHORS
Preface to the Series
Preface for The History of Alternative Test Methods in Toxicology
1 - Setting the Scene
1.1 - The Introduction and Influence of the Concept of Humane Experimental Technique
1. INHUMANITY AND THE THREE RS CONCEPT
2. PROGRESS FOLLOWING THE PUBLICATION OF THE PRINCIPLES
3. ALTERNATIVES
4. PROGRESS IN THE 1980S
5. INTO THE 1990S
REFERENCES
1.2 - Types of Toxicity and Applications of Toxicity Testing
1. THE NEED FOR TESTING
2. TYPES OF TOXICITY TEST
3. APPLICATIONS OF TOXICITY TESTING
4. RISK MANAGEMENT
5. THE REPLACEMENT OF ANIMAL TESTS
6. CONCLUSIONS
REFERENCES
1.3 - The Key Technologies
1. INTRODUCTION
2. TECHNOLOGY DRIVERS
2.1 Tissue Culture Systems
2.2 Reporter Gene Assays and Biosensors
2.3 Miniaturised and Large-Scale Culture Systems
2.4 Toxicogenomics and Proteomics
2.5 Other Enabling Technologies
3. DISCUSSION AND CONCLUSIONS
REFERENCES
2 - Contributions From Countries, Regions and Organisations
2.1 - Alternative Methods in Toxicity Testing in the UK
1. EARLY DAYS
2. THE FUND FOR THE REPLACEMENT OF ANIMALS IN MEDICAL EXPERIMENTS
3. THE NATIONAL CENTRE FOR THE THREE RS
4. OTHER ORGANISATIONS
REFERENCES
2.2 - Contributions From the German-Speaking Countries
1. INTRODUCTION
2. CONTRIBUTIONS FROM SWITZERLAND
2.1 The Foundation Research 3R
2.2 The Swiss Institute for Alternatives to Animal Testing
2.3 The Fondation Egon Naef Pour la Recherche In Vitro
2.4 Swiss Governmental Agency Support for the Three Rs Concept
3. CONTRIBUTIONS FROM GERMANY.
3.1 Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergaenzungsmethoden zum Tierversuch (ZEBET)
3.2 Reducing Animal Numbers in Regulatory Toxicity Testing
3.3 The Regulatory Acceptance of In Vitro Toxicity Tests Successfully Validated at ZEBET
3.4 The Funding of Research on In Vitro Toxicity Testing in Germany
3.5 ZEBET's Wider Activities
4. CONTRIBUTIONS FROM AUSTRIA
5. CONCLUSIONS
REFERENCES
2.3 - Contributions to Alternatives From Italy and Spain
1. ACTIVITIES IN ITALY RELATED TO ALTERNATIVE METHODS
1.1 The Italian Association for In Vitro Toxicology
1.2 The Italian National Platform for Alternative Methods
1.3 The Italian National Reference Centre
1.4 The Three Rs Declaration of Bologna
2. ACTIVITIES IN SPAIN RELATED TO IN VITRO PHARMACOTOXICOLOGY
2.1 The ICLAS/CSIC Working Group on Complementary Methods
2.2 The Spanish Working Group on Alternative Methods
2.3 The 3ERRES Mailing List on Alternatives
2.4 Spanish Scientific Productivity Related to In Vivo and In Vitro Alternative Methods
2.5 The Inventory of the Spanish Institutions and Scientists Involved in Alternatives to the Use of Laboratory Animals
2.6 The Spanish Network for the Development of Alternative Methods
REFERENCES
2.4 - Contributions to Alternatives From The Netherlands, Belgium and France
1. DEVELOPMENT OF ALTERNATIVES TO TOXICITY TESTING IN THE NETHERLANDS
1.1 Early Years
1.2 Recent Technological Developments
1.3 Organisational Frameworks
1.3.1 National Initiatives
1.3.2 International Initiatives
1.4 Implementation of Alternatives
1.5 Conclusions
2. DEVELOPMENT OF ALTERNATIVES TO TOXICITY TESTING IN BELGIUM
2.1 Early Years
2.2 More-recent Three Rs Developments in Belgium
3. DEVELOPMENT OF ALTERNATIVES TO TOXICITY TESTING IN FRANCE
3.1 Early Years.
3.2 Recent Technological Developments
3.3 Organisational Frameworks
3.4 Implementation of Alternatives
3.5 Conclusions
REFERENCES
2.5 - Contributions of the Scandinavian Countries to the Development of Non-Animal Alternatives in Toxicology
1. INTRODUCTION
2. THE DEVELOPMENT AND USE OF ALTERNATIVE IN VITRO METHODS
2.1 Cell Toxicology
2.2 Neurotoxicology
2.3 Ocular Toxicology
2.4 Tissue Modelling
2.5 Reproductive Toxicology
2.6 Toxicokinetics and Biotransformation Modelling
2.7 Genotoxicity and Carcinogenicity Testing In Vitro
2.8 Ecotoxicology
2.9 Skin Sensitisation
3. ALTERNATIVES IN INDUSTRY
4. FINANCING RESEARCH ON NON-ANIMAL ALTERNATIVES, 1980-2016
5. RESEARCH CENTRES ESTABLISHED FOR THE DEVELOPMENT AND VALIDATION OF NON-ANIMAL METHODS
6. EDUCATION AND NON-ANIMAL METHODS
7. CONCLUDING COMMENTS
ACKNOWLEDGEMENTS
REFERENCES
2.6 - The Three Rs and Alternatives in the VisegrAd (V4) Countries
1. CENTRAL EUROPEAN COUNTRIES JOIN WESTERN EUROPEAN COUNTRIES IN THE EU
2. INITIAL THREE RS DEVELOPMENTS IN CZECHOSLOVAKIA
3. THREE RS ACTIVITIES IN THE CZECH REPUBLIC
3.1 The TEMPUS Joint European Project
3.2 World Congresses on Alternatives
3.3 Visit of Professor William Russell in 1997
3.4 Alternatives Conference in Prague, 2001
3.5 SSCT Meeting, 2009
3.6 Major Collaborations
3.7 Government Organisations
3.8 The State Veterinary Administration
4. ACTIVITIES IN SLOVAKIA
4.1 Early Developments in Slovakia
4.2 The National Scientific Network on Alternative Methods
4.3 The Slovak Toxicology Society
4.4 Interdisciplinary Toxicology
4.5 The State Veterinary and Food Administration of the Slovak Republic
4.6 The Private Sector
4.7 International Collaboration
5. ACTIVITIES IN HUNGARY
5.1 Organisations
5.2 Governmental Institutions.
5.3 The Private Sector
5.4 International Collaborations
5.5 Journal
6. THREE RS DEVELOPMENTS IN POLAND
6.1 Animal Experimentation in Poland
6.2 The Promotion of Alternatives
6.3 International Scientific Collaboration
6.4 Concluding Comment
REFERENCES
2.7 - Australia and New Zealand
1. INTRODUCTION
2. THE 1989 AUSTRALIAN SENATE REPORT
3. LOCAL FACTORS
3.1 The Australian Anti-Venom Industry
3.2 Facial Eczema in Sheep
4. PARALYTIC SHELLFISH TOXIN
5. ENVIRONMENTAL MONITORING
6. COSMETICS TESTING
7. ORGANISATIONS
8. CURRENT REGULATORY INTEREST
9. DISCUSSION AND CONCLUSIONS
REFERENCES
2.8 - Japanese Contributions to the Development of Alternative Test Methods
1. THE JAPANESE SOCIETY FOR ALTERNATIVES TO ANIMAL EXPERIMENTS
1.1 JSAAE Activities
1.2 International Cooperation
1.3 What Is Next for the JSAAE?
2. THE BACKGROUND TO JACVAM
2.1 What Is JaCVAM's Role?
2.2 Regulatory Acceptance and Ongoing Studies
REFERENCES
2.9 - Contributions to the Development of Alternatives in Toxicology in China and Brazil
1. INTRODUCTION: ALTERNATIVES IN CHINA AND BRAZIL
2. ALTERNATIVES IN CHINA
2.1 History of Animal Use Regulations in China
2.2 The Regulatory Framework in China
2.3 Movement Toward the Use and Validation of Alternative Methods in China
2.4 Support for, and Regulatory Implementation of, Alternatives Within China
2.5 Special Difficulties or Hurdles to Accepting and/or Using Alternative Methods
2.6 Future Outlook for Alternatives in China
3. ALTERNATIVES IN BRAZIL
3.1 History of Animal Use Regulations in Brazil
3.2 The Regulatory Framework in Brazil
3.3 Movement Toward the Use and Validation of Alternative Methods in Brazil
3.4 Support for, and Regulatory Implementation of, Alternatives Within Brazil.
3.5 Special Difficulties or Hurdles to Accepting and/or Using Alternative Methods
3.6 Future Outlook for Alternatives in Brazil
REFERENCES
2.10 - The Role of ECVAM
1. THE EARLY YEARS OF ECVAM, 1991-2002
1.1 Validation
1.2 Workshops and Task Forces
1.3 Biologicals
1.4 In-house Research
1.5 Collaboration in Education and Training
1.6 The ECVAM Scientific Information Service
1.7 Collaborations
1.8 Summary
2. THE EVOLUTION OF ECVAM AND ITS NETWORKS
3. ECVAM ACTIVITIES IN THE CONTEXT OF EU POLICY DRIVERS FOR ALTERNATIVES
3.1 EU Legislation on Cosmetic Products
3.2 The EU Chemicals Policy - REACH
3.3 Other EU Chemicals Policies Relevant to Alternatives
3.4 The European Citizens' Initiative `Stop Vivisection'
4. ECVAM'S CONTRIBUTIONS TO INTERNATIONAL HARMONISATION ACTIVITIES WITHIN THE OECD
4.1 OECD Projects of the TGs Programme Currently (Co-)led by ECVAM
4.2 Activities of ECVAM in the OECD Extended Advisory Group for Molecular Screening and Toxicogenomics
4.3 Activities of ECVAM in the OECD Working Party on Hazard Assessment
5. FUTURE OUTLOOK
REFERENCES
2.11 - The Center for Alternatives to Animal Testing in the USA and Europe
1. CAAT‒USA
2. CAAT‒EUROPE
3. THE CAAT PROGRAMMES
3.1 The Grants Programme
3.2 The Avon Programme Project
3.3 The Communications Programme
3.4 Workshops and Technical Reports - The t4 Programme
3.5 Education Programmes
3.6 The Refinement Programme
3.7 US and EU Policy Programmes
4. FROM A SYMPOSIUM SERIES TO WORLD CONGRESSES
5. TOXICOLOGY TESTING IN THE 21ST CENTURY - THE HUMAN TOXOME PROJECT
6. THE EVIDENCE-BASED TOXICOLOGY COLLABORATION
7. THE GREEN TOXICOLOGY COLLABORATION
8. THE READ-ACROSS PRACTICE COLLABORATION
9. THE GOOD CELL CULTURE PRACTICE COLLABORATION
ACKNOWLEDGEMENTS
REFERENCES.
2.12 - USA: ICCVAM and NICEATM.