Principles and Practice of Skin Toxicology

Description

Written by authorities in the field, this book provides a “bottom up” approach to studying skin toxicology. Principles and Practice of Skin Toxicology clearly outlines basic concepts, cites historical and modern references and contains a dictionary for easy reference. The inclusion of global legislation and regulatory aspects on the topic makes this a comprehensive review for every practitioner, clinical researcher in industry and academia, and MSc and PhD student of toxicology.

• Different sections cover skin structure and function, principles and measurement of skin absorption, clinical aspects of dermal toxicity and in vitro alternatives.
• A section on regulatory and legislative aspects includes case studies from the UK that fulfill European Union and US FDA requirements.
• A glossary provides definitions of technical terms, and the chapters contain an introduction, learning boxes and summary section for ease of use.
• Includes a chapter on drug delivery through the skin.
• Addresses risk assessment: a key area for the interpretation of skin absorption data that is rarely covered.

Contents

Foreword
Preface
Acknowledgements
List of contributors

PART I Introduction

1 Cutaneous anatomy and function -Robert P. Chilcott

• 1.1 Introduction and scope
• 1.2 Surface features
• 1.3 Functional histology of the epidermis and associated structures
• 1.4 Species differences
• Summary
• References

2 Biochemistry of the skin -Simon C. Wilkinson

• 2.1 Introduction and scope
• 2.2 Protein synthesis and organisation during epidermal differentiation
• 2.3 Lipid synthesis and organisation during epidermal differentiation
• 2.4 Lipid classes in the stratum corneum
• 2.5 Stratum corneum turnover
• 2.6 Biotransformations in skin
• Summary
• References

3 Skin photobiology - Mark A. Birch-Machin and Simon C. Wilkinson

• 3.1 Introduction and scope
• 3.2 Photoprotection and melanogenesis
• 3.3 Increased environmental ultraviolet radiation exposure and its link with photoageing and skin cancer
• 3.4 Mitochondrial DNA as a biomarker of sun exposure in human skin
• 3.5 Apoptosis
• 3.6 Sun protection
• Summary
• References

PART II Skin Absorption

4 Skin as a route of entry - Simon C. Wilkinson

• 4.1 Salient anatomical features of the stratum corneum – the ‘brick and mortar model’
• 4.2 Species and regional variation in skin structure
• 4.3 Species and regional variation in skin permeability
• 4.4 Intra- and inter-individual variation in percutaneous absorption
• 4.5 Effect of age on skin barrier function
• 4.6 Role of skin appendages
• 4.7 The in vitro skin sandwich model
• 4.8 Penetration of particles through appendages
• Summary
• References

5 Physicochemical Factors Affecting Skin Absorption - Keith R. Brain and Robert P. Chilcott

• 5.1 Introduction
• 5.2 Physicochemical properties
• 5.3 Exposure considerations
• Summary
• References

6 Principles of Diffusion and Thermodynamics - W. John Pugh and Robert P. Chilcott

• 6.1 Introduction and scope
• 6.2 Some definitions pertaining to skin absorption kinetics
• 6.3 Basic concepts of diffusion
• 6.4 Fick’s Laws of diffusion
• 6.5 Thermodynamic activity
• 6.6 Skin absorption of a substance from two different vehicles
• 6.7 Partitioning
• 6.8 Diffusivity
• 6.9 Skin absorption data and risk assessments
• Summary
• References

7 In vivo measurements of skin absorption - James C. Wakefield and Robert P. Chilcott

• 7.1 Introduction and scope
• 7.2 Why conduct in vivo studies?
• 7.3 Ethics and legislation
• 7.4 Standard methodology: OECD Guideline 427
• 7.5 Alternative in vivo methods
• Summary
• References

8 In vitro percutaneous absorption measurements - Ruth U. Pendlington

• 8.1 Introduction and scope
• 8.2 Regulatory guidelines
• 8.3 Why assess percutaneous absorption in vitro?
• 8.4 Basic principle of in vitro percutaneous absorption measurements
• 8.5 Choice of diffusion cell
• 8.6 Skin membrane considerations
• 8.7 Integrity measurements
• 8.8 Choice of receptor fluid and sampling considerations
• 8.9 Test material considerations
• 8.10 Application of test preparation to the skin
• 8.11 Examples of results from in vitro skin absorption studies
• 8.12 What is considered to be absorbed?
• 8.13 Micro-autoradiography
• Summary
• References

PART III Toxicological Assessment

9 Skin immunology and sensitisation - David A. Basketter

• 9.1 Introduction
• 9.2 Definitions
• 9.3 Skin sensitisation
• 9.4 Identification of skin sensitisers
• 9.5 Risk assessment
• 9.6 Other types of allergic skin reaction
• 9.7 Future prospects
• Summary
• References

10 In vitro phototoxicity assays - Penny Jones

• 10.1 Introduction and scope
• 10.2 In vitro strategies for phototoxicity testing
• 10.3 The UV/visible absorption spectrum as a pre-screen for phototoxicity
• 10.4 In vitro assays for phototoxicity using monolayer cultures
• 10.5 In vitro assays for photoallergenicity
• 10.6 In vitro assays for phototoxicity using human 3-D skin models
• Summary
• References

11 In vitro alternatives for irritation and corrosion assessment - Penny Jones

• 11.1 Introduction and scope
• 11.2 Acute dermal irritation/corrosion
• 11.3 Validation/regulatory status of in vitro assays for skin corrosion
• 11.4 In vitro tests for skin corrosion
• 11.5 Validation/regulatory status of in vitro assays for skin irritation
• 11.6 In vitro tests for skin irritation
• Summary
• References

12 Instruments for measuring skin toxicity - Helen Taylor

• 12.1 Introduction and scope
• 12.2 Skin surface pH
• 12.3 Biomechanical properties
• 12.4 Sebum
• 12.5 Skin surface contours
• 12.6 Thickness
• 12.7 Desquamation
• 12.8 Applications and measurement of transepidermal water loss
• 12.9 Guidance for TEWL measurements
• 12.10 Hydration measurement
• 12.11 Guidance for hydration measurements
• 12.12 Relationship between hydration and dermal toxicity
• 12.13 Colour measurement
• 12.14 Measurement of vascular perfusion
• 12.15 A final word of caution
• Summary
• References

PART IV Clinical Aspects

13 Introduction to dermatology - Manjunatha Kalavala and Alex Anstey

• 13.1 Introduction and scope
• 13.2 Clinical assessment of patient with skin disease
• 13.3 Cutaneous manifestations of disease following exposure to chemicals and pharmaceutical formulations
• 13.4 Overview of standard treatments
• Summary

14 Clinical aspects of phototoxicity - Anthony D. Pearse and Alex Anstey

• 14.1 Introduction and scope
• 14.2 UV-induced skin reactions
• 14.3 Phototoxicity (photoirritancy) reactions
• 14.4 Photosensitive reactions
• Summary
• References

15 Occupational skin diseases - Jon Spiro

• 15.1 Introduction and scope
• 15.2 Dermatitis
• 15.3 Development of occupational dermatitis
• 15.4 Patterns of occupational dermatitis
• 15.5 Incidence of occupational dermatitis
• 15.6 Effects of dermatitis on work
• 15.7 The outlook in occupational dermatitis
• 15.8 Identification of occupational dermatitis
• 15.9 Other occupational skin disorders
• 15.10 Investigation of a case of dermatitis at work
• Summary
• References

16 Prevention of occupational skin disease - Chris Packham

• 16.1 Prevention of occupational skin disease
• 16.2 Defining the problem
• 16.3 Material safety data sheets
• 16.4 Chain of responsibility
• 16.5 Managing dermal exposure
• 16.6 Selection and use of personal protective equipment
• 16.7 Protective or ‘barrier’ creams: do they have a role?
• 16.8 The role of education and training
• 16.9 Conclusions
• Summary
• References

PART V Regulatory

17 Occupational skin exposures: legal aspects - Chris Packham

• 17.1 Introduction and scope
• 17.2 Brief overview of current United Kingdom legislation
• 17.3 The employer’s perspective
• 17.4 Hazard identification
• 17.5 Risk assessment
• 17.6 Gloves: a note of caution
• Summary
• References

18 Safety assessment of cosmetics: an EU perspective - Jo Larner

• 18.1 Introduction and scope
• 18.2 Overview and scope of Cosmetics Directive 76/768/EC
• 18.3 Overview of the requirements of the EU Cosmetics Directive
• 18.4 Scientific advice
• 18.5 Influence of other legislation
• 18.6 Adverse effects from cosmetics
• 18.7 Toxicity of cosmetic ingredients
• 18.8 The safety assessment
• 18.9 A final consideration
• Summary
• References
• Appendix 18.1 Additional obligations for cosmetic suppliers

19 Regulatory dermatotoxicology and international guidelines -Adam Woolley

• 19.1 Introduction
• 19.2 Regulatory context
• 19.3 Product groups and the human context
• 19.4 Dermal toxicology with the different product groups
• 19.5 Factors in dermal toxicity
• 19.6 Repeat dose dermal toxicology
• 19.7 Classic short-term dermal toxicity studies
• 19.8 Pragmatic considerations
• Summary
• References

20 Glossary of main terms and abbreviations -James C. Wakefield

Index