Dermatotoxicology Methods

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 Assessment of Alternative Method Readiness for the Validation Process -- Confirming Alternative Method Reliability in a Validation Study -- Assessing Alternative Method Relevance -- Conclusion -- Acknowledgments -- References -- CHAPTER 30 -- Update on Agency Initiatives in Alternative Methods /Sidney Green -- Introduction -- Ocular Symposium -- Dermal Irritation /Corrosivity -- References -- Index.