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E-grāmata: Dermatotoxicology Methods: The Laboratory Worker's Ready Reference [Taylor & Francis e-book]

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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.
Contributors xiii
Preface xvii
Preface to Dermatotoxicology, Fifth Edition xix
Chapter 1 Structure-Activity Relationships in Percutaneous Absorption
1(6)
Jurij J. Hostynek
Introduction
1(1)
Traditional Assessment of Skin Penetration
2(1)
Structure-Activity Approach to Percutaneous Absorption
2(2)
Limitations of QSAR
4(1)
Conclusions
4(1)
References
4(3)
Chapter 2 Methods for in Vitro Percutaneous Absorption
7(8)
Robert L. Bronaugh
Introduction
7(1)
In Vitro Methodology
7(5)
In Vivo and In Vitro Correlations
12(1)
Barrier Properties of Skin Constructs
12(1)
References
13(2)
Chapter 3 Percutaneous Absorption in Humans
15(14)
Ronald C. Wester
Howard I. Maibach
Introduction
15(2)
Integrated Dermatopharmacokinetics in Man (Hydroquinone)
17(10)
Discussion
27(1)
References
27(2)
Chapter 4 Percutaneous Absorption of Hazardous Substances from Soil and Water
29(12)
Ronald C. Wester
Howard I. Maibach
Introduction
29(9)
Discussion
38(1)
Acknowledgment
39(1)
References
39(2)
Chapter 5 Isolated Perfused Porcine Skin Flap
41(10)
Jim E. Riviere
Introduction
41(1)
Overview of Method
41(3)
Assessment of Viability
44(1)
Percutaneous Absorption
45(1)
Dermatopharmacokinetics
46(1)
Other Applications
47(1)
Discussion
48(1)
References
48(3)
Chapter 6 Methods in Physiologically Based Pharmacokinetic Modeling
51(18)
James N. McDougal
Introduction
51(1)
Why use PB-PK Models?
51(1)
When can PB-PK Models be used?
52(1)
How do you use PB-PK Models?
53(1)
What are the Components of a PB-PK Model?
54(8)
How do you develop PB-PK Models?
62(4)
Conclusion
66(1)
Nomenclature
66(1)
References
66(3)
Chapter 7 Methods for In Vitro Skin Metabolism Studies
69(6)
Robert L. Bronaugh
Introduction
69(1)
In Vitro Methodology
70(1)
Skin Metabolism During Percutaneous Absorption
71(2)
References
73(2)
Chapter 8 Developing a Toxicology Evaluation Plan for Transdermal Delivery Systems
75(14)
Mary E. Prevo
Michel Cormier
James Matriano
Assessment of Previous Experience
75(1)
Transdermal Product Assessment: Issues in Test Selection
76(7)
Summary
83(1)
References
83(6)
Chapter 9 Animal, Human, and In Vitro Test Methods for Predicting Skin Irritation
89(26)
Sunita M. Patil
Esther Patrick
Howard I. Maibach
Animal Tests for Predicting Skin Irritation
90(5)
Human Tests for Predicting Skin Irritation
95(6)
In Vitro Skin Irritation Assays: Relevance to Human Skin
101(7)
Summary
108(1)
References
108(7)
Chapter 10 Structure-Activity Relationships in Contact Sensitization: Classification and Ranking of Allergens
115(6)
Jurij J. Hostynek
Introduction
115(1)
Creating a QSAR Model
116(1)
The Classification Model
116(2)
The Rank Model
118(1)
Conclusion
118(1)
References
119(2)
Chapter 11 Test Methods for Allergic Contact Dermatitis in Animals
121(24)
Georg Klecak
Introduction
121(2)
General Principles
123(2)
Split Adjuvant Technique
125(2)
Freund's Complete Adjuvant Test
127(1)
The Modified Draize Test
128(2)
The Buehler Test
130(1)
The Open Epicutaneous Test
131(1)
Modified Guinea Pig Maximization Test
131(1)
The Cumulative Contact Enhancement Test
132(1)
The Epicutaneous Maximization Test
133(1)
Single Injection Adjuvant Test
134(1)
The Tierexperimenteller Nachweis (TINA) Test
135(1)
The Footpad Test
136(1)
The Guinea Pig Allergy Test Adapted to Cosmetic Ingredients
137(1)
The Ear/Flank Test (Stevens Test)
138(1)
Conclusions
139(1)
References
139(6)
Chapter 12 The Local Lymph Node Assay
145(8)
Ian Kimber
Introduction
145(1)
Methods
145(3)
Application and Validation: Current Status
148(2)
Conclusions
150(1)
References
150(3)
Chapter 13 Test Methods for Allergic Contact Dermatitis in Humans
153(8)
Francis N. Marzulli
Howard I. Maibach
Predictive Tests
154(1)
Diagnostic Tests
154(4)
Excited Skin Syndrome
158(1)
References
158(3)
Chapter 14 Contact Urticaria Syndrome
161(16)
Smita Amin
Arto Lahti
Howard I. Maibach
Introduction
161(1)
Symptoms
161(1)
Etiology and Mechanisms
161(8)
Diagnostic Tests
169(2)
References
171(6)
Chapter 15 Diagnostic Tests in Dermatotoxicology
177(10)
Smita Amin
Antti I. Lauerma
Howard I. Maibach
Introduction
177(1)
Drug Eruptions
177(4)
Contact Dermati ti s
181(2)
Contact Urticaria Syndrome: Immediate Contact Reactions
183(1)
References
184(3)
Chapter 16 Use of Cytokines in Dermatotoxicology
187(20)
G. Frank Gerberick
Elizabeth E. Sikorski
Cindy A. Ryan
Laura C. Limardi
Introduction
187(2)
Methods of Cytokine Analysis
189(4)
Skin Model Systems for Examining Cytokines
193(7)
Summary
200(1)
References
200(7)
Chapter 17 Characterization of Epidermal Langerhans Cells
207(10)
Marie Cumberbatch
Rebecca J. Dearman
Ian Kimber
Introduction
207(1)
Epidermal Langerhans Cells and Cutaneous Immune Responses
207(1)
Cytokine Products of Epidermal Langerhans Cells
208(1)
Practical Application of Langerhans Cell Characterization
209(1)
Methods
210(3)
References
213(4)
Chapter 18 Measuring and Quantifying Ultraviolet Radiation Exposures
217(12)
David H. Sliney
Introduction
217(4)
Optical Radiation Sources
221(1)
UV Measurement
222(3)
General Biophysical and Photobiological Factors
225(2)
References
227(2)
Chapter 19 Animal Models for Phototoxicity Testing
229(16)
Lark A. Lambert
Wayne G. Warner
Andrija Kornhauser
Introduction
229(1)
Overview of Animal Models for Phototoxicity Testing
229(5)
Specific Animal Models
234(4)
Comparison of Species in Phototoxicity Testing
238(1)
In Vivo Versus In Vitro Phototoxicity Testing
239(2)
Summary
241(1)
References
241(4)
Chapter 20 Photoirritation (Phototoxicity) Testing in Humans
245(6)
Francis N. Marzulli
Howard I. Maibach
Definition
245(1)
Screening
245(1)
Spectral Measurements
245(1)
Precautions
245(1)
Exploratory Studies
246(2)
Conclusions
248(1)
References
248(3)
Chapter 21 The Evaluation of Photoallergic Contact Sensitizers in Humans
251(8)
Kays Kaidbey
Introduction
251(1)
Photomaximization Test
252(1)
Evaluation of Some Photocontact Sensitizers
252(4)
Photopatch Testing
256(1)
Action Spectrum s
256(1)
Conclusions
257(1)
References
257(2)
Chapter 22 Chemical Leukoderma (Depigmentation)
259(12)
Howard I. Maibach
Jorge R. Tow
Gerald A. Gellin
Leslie P. McCarty
Introduction
259(1)
Chemical Structure
259(2)
Repigmentation
261(1)
Animal Models
261(5)
In Vitro Studies
266(1)
Human Studies
266(1)
Mechanism of Action
266(1)
References
267(4)
Chapter 23 New Models to Assess In Vitro Action of Retinoids
271(10)
Serge Michel
Braham Shroot
Introduction
271(1)
Methods
272(2)
Results
274(3)
Conclusion
277(1)
Acknowledgments
278(1)
References
278(3)
Chapter 24 Sample Protocols for Carcinogenesis and Photocarci nogenesi s
281(22)
P. Donald Forbes
Christopher P. Sambuco
George E. Dearlove
Robert M. Parker
Anthony L. Kiorpes
John H. Wedig
Introduction
281(1)
A Sample Protocol for Carcinogenesis Testing
282(9)
Photocarci nogenesi's Safety Testing
291(2)
A Sample Protocol for Photocarcinogenesis Testing
293(8)
References
301(2)
Chapter 25 Testing for Reproductive Hazards from Dermal Exposure
303(10)
Thomas F. X. Collins
Introduction
303(1)
Testing and Methodology
303(1)
Considerations and General Recommendations
304(1)
Test Procedures for Developmental Toxicity Studies
304(3)
Test Procedure for Reproduction Studies
307(4)
References
311(2)
Chapter 26 Quantitative Sensory Testing
313(6)
Gil Yosipovitch
David Yarnitsky
Introduction
313(4)
References
317(2)
Chapter 27 Alternative Methods in Dermatotoxicology
319(18)
Mary A. Perkins
Michael K. Robinson
Rosemarie Osborne
Introduction
319(1)
Materials and Methods
320(4)
Results
324(5)
Discussion and Summary
329(6)
References
335(2)
Chapter 28 Skin Equivalents to Measure Phototoxicity
337(14)
Andre Rougier
Catherine Cohen
Roland Roguet
Introduction
337(1)
Cell Culture Conditions
338(1)
Photoprotective Assessment of Sunscreens Using 3-D Cultures of Keratinocytes
339(1)
Assessment of the Phototoxic Potential of Chemicals Using 3-D Cultures of Keratinocytes
340(1)
Treatment of the Episkin Samples
341(3)
Assessment of Lipoperoxidation Induced by UVA Using a 3-D Culture of Keratinocytes
344(4)
General Conclusion
348(1)
References
348(3)
Chapter 29 A Practical Process for Assessing the Validity of Alternative Methods for Toxicity Testing
351(26)
Leon H. Bruner
Gregory J. Carr
Mark Chamberlain
Rodger D. Curren
Introduction
351(1)
The Definition of Validation
351(1)
Reliability
352(1)
Relevance
352(1)
Initiating the Validation Process
352(1)
Establishing the Relevance of the Alternative Method
352(2)
Confirming the Establishment of Common Protocols and Standard Operating Procedures (SOP)
354(1)
Confirming that Measures of Reliability to Be Tested in the Validation Study Have Been Adequately Defined
354(1)
Defining the Reproducibility of the Test Results from an Assay
354(1)
Defining the Reproducibility of Predictions from an Alternative Method Through the Use of Prediction Models
355(1)
Completing the Initial Assessment of Alternative Method Readiness for the Validation Process
355(1)
Confirming Alternative Method Reliability in a Validation Study
355(12)
Assessing Alternative Method Relevance
367(6)
Conclusion
373(1)
Acknowledgments
374(1)
References
374(3)
Chapter 30 Update on Agency Initiatives in Alternative Methods
377(6)
Sidney Green
Introduction
377(1)
Ocular Symposium
378(2)
Dermal Irritation/Corrosivity
380(1)
References
381(2)
Index 383
Francis N. Marzulli
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