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Dermatotoxicology Methods
The Laboratory Worker's Ready Reference





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ISBN 9781560326724
Published June 10, 1998 by CRC Press
390 Pages

 
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Book Description

This work presents and evaluates methods employed to identify the potential of certain types of chemicals to adversely affect the skin. A variety of test methods are included such as tests for skin penetration, metabolism, irritation, the skin immune system, photo effects, skin cancer, and topical effects of retinoids and depigmenting chemicals. Tests for chemicals that affect the reproductive and nervous system are also included. Both animal and human tests that have been standardised and tests that are under development and employ animal alternatives are addressed in this book. Besides different testing methods, a rationale for accepting non-animal models and a review of some regulatory agency discussions about animal alternative tests are included.

Table of Contents

Contributors -- Preface -- Preface to Dermatotoxicology, Fifth Edition -- CHAPTER 1 -- Structure-Activity Relationships in Percutaneous Absorption /Jurij J. Hostynek -- Introduction -- Traditional Assessment of Skin Penetration -- Structure-Activity Approach to Percutaneous Absorption -- Limitations of QSAR -- Conclusions -- References -- CHAPTER 2 -- Methods for in Vitro Percutaneous Absorption /Robert L. Bronaugh -- Introduction -- In Vitro Methodology -- In Vivo and In Vitro Correlations -- Barrier Properties of Skin Constructs -- References -- CHAPTER 3 -- Percutaneous Absorption in Humans /Ronald C. Wester and Howard I. Maibach -- Introduction -- Integrated Dermatopharmacokinetics in Man (Hydroquinone) -- Discussion -- References -- CHAPTER 4 -- Percutaneous Absorption of Hazardous Substances from Soil and Water /Ronald C. Wester and Howard /. Maibach -- Introduction -- Discussion -- Acknowledgment -- References -- CHAPTER 5 -- Isolated Perfused Porcine Skin Flap /Jim E. Riviere -- Introduction -- Overview of Method -- Assessment of Viability -- Percutaneous Absorption -- Dermatopharmacokinetics -- Other Applications -- Discussion -- References -- CHAPTER 6 -- Methods in Physiologically Based Pharmacokinetic Modeling /James N. McDougal -- Introduction -- Why use PB-PK Models? -- When can PB-PK Models be used? -- How do you use PB-PK Models? -- What are the Components of a PB-PK Model? -- How do you develop PB-PK Models? -- Conclusion -- Nomenclature -- References -- CHAPTER 7 -- Methods for In Vitro Skin Metabolism Studies /Robert L. Bronaugh -- Introduction In Vitro Methodology -- Skin Metabolism During Percutaneous Absorption -- References -- CHAPTER 8 -- Developing a Toxicology Evaluation Plan for Transdermal Delivery Systems Mary E. Prevo, Michel Cormier; and James Matriano -- Assessment of Previous Experience -- Transdermal Product Assessment: Issues in Test Selection -- Summary -- References -- CHAPTER 9 -- Animal, Human, and In Vitro Test Methods for Predicting Skin Irritation /Sunita M. Patil, Esther Patrick, and Howard I. Maibach -- Animal Tests for Predicting Skin Irritation -- Human Tests for Predicting Skin Irritation -- In Vitro Skin Irritation Assays: Relevance to Human Skin -- Summary -- References -- CHAPTER 10 -- Structure-Activity Relationships in Contact Sensitization: Classification and Ranking of Allergens /Jurij J. Ho sty nek -- Introduction -- Creating a QSAR Model -- The Classification Model -- The Rank Model -- Conclusion -- References -- CHAPTER 11 -- Test Methods for Allergic Contact Dermatitis in Animals /Georg Klecak -- Introduction -- General Principles -- Split Adjuvant Technique -- Freund’s Complete Adjuvant Test -- The Modified Draize Test -- The Buehler Test -- The Open Epicutaneous Test -- Modified Guinea Pig Maximization Test -- The Cumulative Contact Enhancement Test -- The Epicutaneous Maximization Test -- Single Injection Adjuvant Test -- The Tierexperimenteller Nachweis (TINA) Test -- The Footpad Test -- The Guinea Pig Allergy Test Adapted to Cosmetic Ingredients -- The Ear /Flank Test (Stevens Test) -- Conclusions -- References -- CHAPTER 12 -- The Local Lymph Node Assay /Ian Kimber -- Introduction -- Methods -- Application and Validation: Current Status -- Conclusions -- References -- CHAPTER 13 -- Test Methods for Allergic Contact Dermatitis in Humans /Francis N. Marzulli and Howard /. Maibach -- Predictive Tests -- Diagnostic Tests -- Excited Skin Syndrome -- References -- CHAPTER 14 -- Contact Urticaria Syndrome /Smita Amin, Arto Lahti, and Howard I. Maibach -- Introduction -- Symptoms -- Etiology and Mechanisms -- Diagnostic Tests -- References -- CHAPTER 15 -- Diagnostic Tests in Dermatotoxicology /Smita Amin, Antti I. Lauerma, and Howard /. Maibach -- Introduction -- Drug Eruptions -- Contact Dermatitis -- Contact Urticaria Syndrome: Immediate Contact Reactions References -- CHAPTER 16 -- Use of Cytokines in Dermatotoxicology /G. Frank Gerberick, Elizabeth E. Sikorski, Cindy A. Ryan, and Laura C. Limardi -- Introduction -- Methods of Cytokine Analysis -- Skin Model Systems for Examining Cytokines -- Summary -- References -- CHAPTER 17 -- Characterization of Epidermal Langerhans Cells /Marie Cumberbatch, Rebecca J. Dearman, and Ian Kimber -- Introduction -- Epidermal Langerhans Cells and Cutaneous Immune Responses -- Cytokine Products of Epidermal Langerhans Cells -- Practical Application of Langerhans Cell Characterization -- Methods -- References -- CHAPTER 18 -- Measuring and Quantifying Ultraviolet Radiation Exposures /David H. Sliney -- Introduction -- Optical Radiation Sources -- UV Measurement -- General Biophysical and Photobiological Factors -- References -- CHAPTER 19 -- Animal Models for Phototoxicity Testing /Lark A. Lambert, Wayne G. Warner; and Andrija Kornhauser -- Introduction -- Overview of Animal Models for Phototoxicity Testing -- Specific Animal Models -- Comparison of Species in Phototoxicity Testing -- In Vivo Versus In Vitro Phototoxicity Testing -- Summary -- References -- CHAPTER 20 -- Photoirritation (Phototoxicity) Testing in Humans /Francis N. Marzulli and Howard I. Maibach -- Definition -- Screening -- Spectral Measurements -- Precautions -- Exploratory Studies -- Conclusions -- References -- CHAPTER 21 -- The Evaluation of Photoallergic Contact Sensitizers in Humans /Kays Kaidbey -- Introduction -- Photomaximization Test -- Evaluation of Some Photocontact Sensitizers -- Photopatch Testing -- Action Spectrum -- Conclusions -- References -- CHAPTER 22 -- Chemical Leukoderma (Depigmentation) /Howard I. Maibach, Jorge R. Toro, Gerald A. Gellin, and Leslie P. McCarty -- Introduction -- Chemical Structure -- Repigmentation -- Animal Models -- In Vitro Studies -- Human Studies -- Mechanism of Action -- References -- CHAPTER 23 -- New Models to Assess In Vitro Action of Retinoids /Serge Michel and Braham Shroot -- Introduction -- Methods -- Results -- Conclusion -- Acknowledgments -- References -- CHAPTER 24 -- Sample Protocols for Carcinogenesis and Photocarcinogenesis /P. Donald Forbes, Christopher P. Sambuco, George E. Dearlove, Robert M. Parker, Anthony L. Kiorpes, and John H. Wedig -- Introduction -- A Sample Protocol for Carcinogenesis Testing Photocarcinogenesis Safety Testing -- A Sample Protocol for Photocarcinogenesis Testing -- References -- CHAPTER 25 -- Testing for Reproductive Hazards from Dermal Exposure /Thomas F. X. Collins -- Introduction -- Testing and Methodology -- Considerations and General Recommendations -- Test Procedures for Developmental Toxicity Studies -- Test Procedure for Reproduction Studies -- References -- CHAPTER 26 -- Quantitative Sensory Testing /Gil Yosipovitch and David Yarnitsky -- Introduction -- References -- CHAPTER 27 -- Alternative Methods in Dermatotoxicology /Mary A. Perkins, Michael K. Robinson, and Rosemarie Osborne -- Introduction -- Materials and Methods -- Results -- Discussion and Summary -- References -- CHAPTER 28 -- Skin Equivalents to Measure Phototoxicity /Andre Rougier, Catherine Cohen, and Roland Roguet -- Introduction -- Cell Culture Conditions -- Photoprotective Assessment of Sunscreens Using 3-D Cultures of Keratinocytes -- Assessment of the Phototoxic Potential of Chemicals Using 3-D Cultures of Keratinocytes -- Treatment of the Episkin Samples -- Assessment of Lipoperoxidation Induced by UVA Using a 3-D Culture of Keratinocytes -- General Conclusion -- References -- CHAPTER 29 -- A Practical Process for Assessing the Validity of Alternative Methods for Toxicity Testing /Leon H. Bruner; Gregory J. Carr; Mark Chamberlain, and Rodger D. Curren Introduction -- The Definition of Validation -- Reliability -- Relevance -- Initiating the Validation Process -- Establishing the Relevance of the Alternative Method -- Confirming the Establishment of Common Protocols and Standard Operating Procedures (SOP) -- Confirming that Measures of Reliability to Be Tested in the Validation Study Have Been Adequately Defined -- Defining the Reproducibility of the Test Results from an Assay -- Defining the Reproducibility of Predictions from an Alternative Method Through the Use of Prediction Models -- Completing the Initial

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