A Guide to Practical Toxicology: Evaluation, Prediction, and Risk, Second Edition

by Woolley; David

Edition: 2nd

ISBN13: 9781420043143

ISBN10: 1420043145

Format: Nonspecific Binding

Pub. Date: 2008-09-22

Publisher(s): CRC Press

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Summary

This practical, user-friendly, and informative text surveys basic principles of toxicology. It is an invaluable guide to evaluating toxicity and related data, approaching toxicity testing and interpretation, and understanding the concepts of hazard prediction and risk assessment and management.A Guide to Practical Toxicology :examines how to evaluate various groups of chemicals'”pharmaceuticals, cosmetics, and agrochemicals provides insights on toxicity determination, normality and naturality, prediction, and regulationTwo all-new chapters cover:safety pharmacology evaluation of different chemical classes

Author Biography

Adam Woolley is Director and Consultant Toxicologist, ForthTox Limited, Linlithgow, UK

Preface	p. v
Acknowledgements	p. vii
Introduction to Toxicology: The Necessity of Measurement	p. 1
Introduction	p. 1
The Beginnings of Toxicological Measurement	p. 3
Toxicology and Toxicity Defined	p. 7
It is Natural So It Must be Safe-Everyday Toxicological Conundrums	p. 9
Natural Medicines and Poisons	p. 11
General Objectives of Toxicological Study	p. 14
Nature and Outcome of Toxic Reactions	p. 16
Cellular Basis and Consequences of Toxic Change	p. 18
Expression of Toxicity	p. 22
Target Organ Expression of Toxicity	p. 24
The Necessity for Toxicological Assessment	p. 29
Ethics of Toxicological Assessment	p. 30
The Three Rs: Reduce, Refine, and Replace	p. 32
Normality: Definition and Maintenance	p. 37
Introduction	p. 37
What is Normality?	p. 38
Normality as a Range	p. 41
Experimental Normality	p. 41
Protocol Design and Procedure as Sources of Abnormality	p. 45
Control Groups as Normality	p. 46
Establishing and Maintaining Normality in Experimental Groups	p. 48
Baseline Data and Historical Controls	p. 50
Determination of Toxicity: The Basic Principles	p. 59
Circumstances of Toxicity Testing	p. 59
Effects Sought in Toxicity Studies	p. 61
Basic Principles of Toxicological Investigation	p. 61
Toxicokinetic Design	p. 76
Regulatory Framework and Influences	p. 77
Regulation of Study Conduct-Good Laboratory Practice	p. 80
Determination of Toxicity: In Vitro and Alternatives	p. 89
Introduction	p. 89
Rationale for In Vitro Toxicology	p. 90
How and When to Use In Vitro or Alternative Techniques	p. 92
Considerations in Screening Program Design	p. 93
Areas of Use of In Vitro Toxicology	p. 94
Considerations in the Development of In Vitro Tests	p. 95
Validation of In Vitro Methods	p. 96
Test Systems and Endpoints	p. 98
Toxicity in Silico	p. 101
Computer Prediction Systems	p. 104
Target Organ Toxicity	p. 104
Functional Toxicity Testing	p. 107
Pharmacology and Safety Pharmacology In Vitro	p. 107
Metabolism	p. 108
Kinetics	p. 108
Toxicity Testing	p. 109
Carcinogenicity	p. 109
Reproductive Toxicity	p. 109
Irritation and Corrosion	p. 110
Phototoxicity	p. 110
Ecotoxicology	p. 110
Pitfalls in In Vitro Toxicology	p. 111
Future Utility	p. 111
Overview	p. 112
Safety Pharmacology	p. 115
Introduction	p. 115
General Principles	p. 116
Tests to be Conducted	p. 117
What to Test?	p. 119
Design	p. 119
Test Systems for Safety Pharmacology	p. 121
Safety Pharmacology in Toxicity Studies	p. 121
Tests and Their Conduct	p. 122
Pitfalls of Safety Pharmacology Studies	p. 128
Overview	p. 129
Determination: General and Reproductive Toxicology	p. 131
General Toxicology	p. 131
Test Systems for General Toxicology	p. 131
Study Designs in General Toxicology	p. 134
Examinations for Specific Toxicities	p. 142
Pitfalls in General Toxicology	p. 145
Reproductive Toxicology	p. 147
Study Designs for Reproductive Toxicology	p. 153
Pitfalls in Reproductive Toxicology	p. 158
Determination: Genotoxicity and Carcinogenicity	p. 161
Genotoxicity	p. 161
Carcinogenicity	p. 176
Pitfalls in Carcinogenicity Studies	p. 187
Determination: Dermal Toxicity-Sensitization, Irritation, and Corrosion	p. 199
Introduction	p. 199
General Principles of Dermal Toxicology	p. 200
Factors in Dermal Toxicity	p. 201
Test Systems	p. 203
Study Design and Parameters Measured	p. 204
Sensitization	p. 207
Pitfalls in Irritation and Sensitization	p. 209
Determination: Environmental Toxicology and Ecotoxicology	p. 213
Introduction	p. 213
Relevance of Environmental Assessment to Chemical Development	p. 214
General Principles of Environmental Toxicology and Ecotoxicology	p. 215
Pollution, Routes of Entry, and Environmental ADME	p. 216
Factors in Testing for Environmental Effect	p. 219
Test Systems and Study Types for Ecotoxicology	p. 220
Environmental Assessment of Agrochemicals	p. 224
Environmental Assessment of Pharmaceuticals	p. 226
Pitfalls in Environmental Toxicology	p. 227
Interpretation: Basic Principles	p. 229
Introduction	p. 229
Steps in Interpretation	p. 231
Use of Background Data in Interpretation	p. 233
Statistics and Significance in Toxicology	p. 234
Assessing Exposure	p. 240
The Reality of Difference-The Interpretation of Small Differences	p. 246
The Reproducibility of Difference	p. 248
Overview of Interpretation	p. 249
Interpretation: Different Data Types	p. 251
Individual Data Sets	p. 251
Safety Pharmacology	p. 252
General Toxicology	p. 253
Morphological Pathology	p. 258
Reproductive Toxicology	p. 266
Genotoxicity	p. 267
Carcinogenicity	p. 271
Environmental Toxicology and Ecotoxicology	p. 273
Case Studies	p. 282
The Fundamentals of Interpretation	p. 287
Prediction of Hazard	p. 291
Introduction	p. 291
Principles of Prediction	p. 294
Steps in the Prediction Process	p. 296
Factors for Consideration in Prediction	p. 300
Prediction from Minimal Databases	p. 304
Computer Models for Toxicity Prediction	p. 305
Prediction for Individuals	p. 315
Prediction Summary	p. 316
Background to Risk Due to Toxicity	p. 319
Introduction	p. 319
Overview of Risk Analysis	p. 319
Levels of Risk and Factors That Affect Risk	p. 323
Summary	p. 335
Risk Assessment in Practice and Setting Exposure Limits	p. 337
Introduction	p. 337
Risk Assessment as a Process	p. 338
Data Quality	p. 338
Data Selection for Risk Assessment	p. 339
Single Effect Versus General Risk Assessment	p. 341
Tools and Models in Risk Assessment	p. 342
Target Population, Dose, and Exposure	p. 345
Process and Factors in Risk Assessment	p. 349
Setting Safety Factors and Margins	p. 356
Exposure Limits	p. 358
Dose Level Selection for Starting Risk Assessment	p. 360
Setting Exposure Limits	p. 364
Summary	p. 368
Risk Assessment and Management in the Workplace	p. 371
Introduction	p. 371
The Historical and Regulatory Background	p. 372
Classification and Exposure Limits	p. 373
Factors in Workplace Risk Assessment	p. 374
Workplace Risk Assessment	p. 374
Workplace Exposure Assessment	p. 375
Risk Management in the Workplace	p. 377
Overview	p. 383
Risk Assessment: Carcinogenicity, The Environment, Evolution, and Overview of Risk Assessment	p. 385
Introduction	p. 385
Notes on Risk Assessment and Carcinogenicity	p. 385
Notes on Risk Assessment and The Environment	p. 395
International Management of Environmental Risks	p. 399
The Evolution of Risk Assessment	p. 399
Overview of Risk Assessment	p. 401
Evaluation of Specific Classes of Chemical	p. 407
Regulatory Influences	p. 409
The Basic Toxicity Test Package	p. 411
Human Pharmaceuticals	p. 411
Veterinary Pharmaceuticals	p. 415
Medical Devices	p. 416
Agrochemicals/Plant Protection Products	p. 419
Biocides	p. 421
Cosmetics	p. 424
General and Industrial Chemicals-Reach	p. 426
Overview	p. 431
The Future of Toxicity Testing and Risk Assessment	p. 435
Introduction	p. 435
Challenges for Toxicology	p. 436
Challenge for Risk Assessment and Management	p. 437
Influences on Toxicity Testing and Risk Assessment	p. 437
Utility of Animal Experiments in Risk Assessment	p. 439
Development of New Test Methods and Models	p. 440
In Vitro Toxicology and the Future	p. 442
Toxicology in Silico	p. 443
The Future of Safety Evaluation and Risk Assessment	p. 443
Useful Websites	p. 445
Bibliography	p. 447
Select Glossary	p. 449
Index	p. 455
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A Guide to Practical Toxicology: Evaluation, Prediction, and Risk, Second Edition

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