Front Cover -- Acute Toxicology Testing -- Copyright Page -- Contents -- Preface to the First Edition -- Preface to the Second Edition -- Chapter 1. Introduction -- Questions of Relevance and Sensitivity -- Defining Test Objectives -- Display of Study Designs: The Line Chart -- Theory and Use of Screens, Innovations, and Alternatives -- References -- Chapter 2. Acute Toxicology Program: Study Design and Development -- Defining the Objective -- Defining Exposure Potential -- The Data Matrix -- Test Selection and Design -- Study Design -- References -- Chapter 3. Tests for Dermal Irritation and Corrosion -- Primary Dermal Irritation Test -- Dermal Corrosivity Test -- Factors Affecting Responses and Test Outcome -- Problems in Testing (and Their Resolutions) -- Design Alternatives and Innovations -- In Vitro Alternatives -- Percutaneous Absorption -- Intracutaneous Reactivity (Irritation) -- Intracutaneous Test -- References -- Chapter 4. Ocular Irritation Testing -- History of Ocular Irritation Testing -- Current in Vivo Test Protocols -- Ocular Irritation Test -- 21-Day Eye Irritation Study in Rabbits -- Adequacy of Current in Vivo Methods -- Limitations of the Rabbit Eye Test -- In Vivo vs in Vitro Tests -- In Vitro Tests -- References -- Chapter 5. Dermal Sensitization -- Mechanisms -- Objectives and General Features -- History -- Modified Buehler Procedure -- Guinea Pig Maximization Test -- Guinea Pig Split Adjuvant Test -- Mouse Ear Swelling Test -- Local Lymph Node Assay -- Test System Manipulation (for all in Vivo Test Systems) -- Current Test Systems: Practical Problems and Solutions -- References -- Chapter 6. Photosensitization and Phototoxicity -- Theory and Mechanisms -- Factors Influencing Phototoxicity/Photosensitization -- Predictive Tests for Phototoxicity -- Guinea Pig -- Mouse Ear Swelling Model.

Alternative Designs: In Vivo Systems -- In Vitro Test Systems -- References -- Chapter 7. Lethality Testing -- Historical Perspective -- Protocol Designs -- Alternatives to Lethality Testing -- References -- Chapter 8. Safety Considerations for the Administration of Agents by the Parenteral Routes -- Parenteral Routes and Rates -- Bolus vs Infusion -- Test Systems for Parenteral Irritation -- Alternatives -- Pyrogenicity -- Blood Compatibility -- Vaginal Irritation -- References -- Chapter 9. Systemic Acute Toxicity Testing -- Screens -- Acute Systemic Toxicity Characterization -- Acute Toxicity Testing with Nonrodent Species -- Acute Mechanistic Studies -- References -- Chapter 10. Routes, Formulations, and Vehicles -- Mechanisms -- Common Routes -- Mechanisms of Absorption -- Techniques -- Gavage Procedure (Rat or Mouse) -- Volume Limitations by Route -- Selection of Route -- Vehicles and Formulation of Materials -- Dosing Calculations -- Comparisons and Contrasts of Routes -- References -- Chapter 11. Considerations Specific to Animal Test Models -- Common Model Species and Their Characteristics -- Cross-Species Extrapolation -- Model Selection -- Limitations of Models -- Susceptibility Factors -- Species Peculiarities -- Considerations of Strain -- Animal Care, Husbandry, and Welfare -- References -- Chapter 12. Statistical Analysis of Acute Toxicology and Safety Studies -- Basics -- Significance and Error in Biomedical Sciences -- Functions of Statistics -- Experimental Design -- Methods -- Applications -- Screening -- References -- Chapter 13. Acute Inhalation -- General Principles -- Basics of Respiratory Physiology -- Mechanics of Exposure -- Dose Quantitation -- Common Test Designs -- Alternative Models -- Common Problems and Their Solutions -- References -- Chapter 14. Problems and Issues -- Use of Available Toxicology Information Sources.

Considerations in Adopting New Test Systems -- In Vitro Models -- SAR Models -- SAR Modeling Methods -- Safety Factors, Potency Predictors, and Protecting Society -- Mixtures -- References -- Appendix A. Common Regulatory and Toxicological Acronyms -- Appendix B. Table for Calculation of Median Effective Dose By Moving Average -- Appendix C. Vehicles -- Appendix D. Definitions of Terms and Lexicon of Clinical Observations -- Index -- Color Plate Section.