Elsevier S & T

Acute Toxicology Testing

Gad, Shayne C.; Chengelis, Christopher P.

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Table of contents
  • Contentsvii
  • Preface to the First Editionxv
  • Preface to the Second Editionxvii
  • Chapter 1. Introduction1
  • Questions of Relevance and Sensitivity3
  • Defining Test Objectives5
  • Display of Study Designs: The Line Chart10
  • Theory and Use of Screens, Innovations, and Alternatives11
  • References15
  • Chapter 2. Acute Toxicology Program: Study Design and Development17
  • Defining the Objective18
  • Defining Exposure Potential19
  • The Data Matrix20
  • Test Selection and Design21
  • Study Design22
  • References30
  • Chapter 3. Tests for Dermal Irritation and Corrosion31
  • Primary Dermal Irritation Test36
  • Dermal Corrosivity Test40
  • Factors Affecting Responses and Test Outcome44
  • Problems in Testing (and Their Resolutions)46
  • Design Alternatives and Innovations48
  • In Vitro Alternatives50
  • Percutaneous Absorption52
  • Intracutaneous Reactivity (Irritation)52
  • Intracutaneous Test52
  • References53
  • Chapter 4. Ocular Irritation Testing57
  • History of Ocular Irritation Testing57
  • Current in Vivo Test Protocols61
  • Ocular Irritation Test63
  • 21-Day Eye Irritation Study in Rabbits70
  • Adequacy of Current in Vivo Methods71
  • Limitations of the Rabbit Eye Test74
  • In Vivo vs in Vitro Tests78
  • In Vitro Tests78
  • References81
  • Chapter 5. Dermal Sensitization85
  • Mechanisms86
  • Objectives and General Features86
  • History89
  • Modified Buehler Procedure90
  • Guinea Pig Maximization Test96
  • Guinea Pig Split Adjuvant Test103
  • Mouse Ear Swelling Test108
  • Local Lymph Node Assay116
  • Test System Manipulation (for all in Vivo Test Systems)118
  • Current Test Systems: Practical Problems and Solutions119
  • References123
  • Chapter 6. Photosensitization and Phototoxicity127
  • Theory and Mechanisms128
  • Factors Influencing Phototoxicity/Photosensitization131
  • Predictive Tests for Phototoxicity132
  • Guinea Pig135
  • Mouse Ear Swelling Model137
  • Alternative Designs: In Vivo Systems139
  • In Vitro Test Systems151
  • References152
  • Chapter 7. Lethality Testing155
  • Historical Perspective157
  • Protocol Designs161
  • Alternatives to Lethality Testing190
  • References194
  • Chapter 8. Safety Considerations for the Administration of Agents by the Parenteral Routes197
  • Parenteral Routes and Rates199
  • Bolus vs Infusion203
  • Test Systems for Parenteral Irritation204
  • Alternatives209
  • Pyrogenicity211
  • Blood Compatibility213
  • Vaginal Irritation214
  • References219
  • Chapter 9. Systemic Acute Toxicity Testing221
  • Screens224
  • Acute Systemic Toxicity Characterization234
  • Acute Toxicity Testing with Nonrodent Species251
  • Acute Mechanistic Studies254
  • References255
  • Chapter 10. Routes, Formulations, and Vehicles257
  • Mechanisms258
  • Common Routes262
  • Mechanisms of Absorption265
  • Techniques278
  • Gavage Procedure (Rat or Mouse)281
  • Volume Limitations by Route284
  • Selection of Route284
  • Vehicles and Formulation of Materials285
  • Dosing Calculations299
  • Comparisons and Contrasts of Routes300
  • References301
  • Chapter 11. Considerations Specific to Animal Test Models305
  • Common Model Species and Their Characteristics306
  • Cross-Species Extrapolation320
  • Model Selection327
  • Limitations of Models332
  • Susceptibility Factors335
  • Species Peculiarities342
  • Considerations of Strain345
  • Animal Care, Husbandry, and Welfare349
  • References355
  • Chapter 12. Statistical Analysis of Acute Toxicology and Safety Studies361
  • Basics362
  • Significance and Error in Biomedical Sciences365
  • Functions of Statistics369
  • Experimental Design372
  • Methods376
  • Applications388
  • Screening393
  • References400
  • Chapter 13. Acute Inhalation403
  • General Principles404
  • Basics of Respiratory Physiology415
  • Mechanics of Exposure437
  • Dose Quantitation446
  • Common Test Designs449
  • Alternative Models459
  • Common Problems and Their Solutions461
  • References464
  • Chapter 14. Problems and Issues467
  • Use of Available Toxicology Information Sources467
  • Considerations in Adopting New Test Systems471
  • In Vitro Models472
  • SAR Models472
  • SAR Modeling Methods476
  • Safety Factors, Potency Predictors, and Protecting Society478
  • Mixtures480
  • References490
  • Appendix A. Common Regulatory and Toxicological Acronyms493
  • Appendix B. Table for Calculation of Median Effective Dose By Moving Average495
  • Appendix C. Vehicles517
  • Appendix D. Definitions of Terms and Lexicon of Clinical Observations525
  • Index529
  • Color Plate SectionColor Plate-1
Book details
  • Vendor Elsevier S & T
  • SKU 9780122722509
  • ISBN-13 9780080525921
  • Author Gad, Shayne C.; Chengelis, Christopher P.
  • Edition 2nd
  • Category Medical
  • Subject Toxicology

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Description eBook delivery & access Reviews
Acute toxicology testing provides the first line of defense against potentially dangerous chemicals. This book is a complete and practical guide to conducting and interpreting all regulatory required and commonly used acute toxicity tests. It presents detailed protocols for all of the common test designs and reviews their development and objectives. Acute Toxicology Testing, Second Edition will interest not only workers in the pharmaceutical industry, but also researchers and students in toxicology and public health.

Key Features
* Over 100 tables summarizing and interpreting results
* Complete coverage of all major test designs and their limitations and advantages
* Current status of alternative test designs and models