Alternatives to Animal Testing

388 Pages  ISBN 1872691463      £15.00

Introduction
Based on the Welcome Speech by Giorgio Sampietro, Colipa President, Belgium

Under the patronage of His Royal Highness Prince Laurent of Belgium, this symposium provided the perfect opportunity for the many dedicated researchers in the scientific community to come together and review the state of the worldwide progress in the development of alternatives to animal testing. It is essential for knowledge to be shared and built upon if the cosmetic, toiletry and perfumery industry is to continue on the path towards the use of alternative safety testing strategies which provide consumers and employees with confidence in products.

his symposium gathered together many of the world's leading experts involved in the search and validation for alternative methods. The more than 250 delegates were from 20 countries encompassing the European Union, Central & Eastern Europe, the USA and Japan, all of whom are key players in scientific research, international and national authorities, European and national governments, animal welfare organisations and, of course, the cosmetic, toiletry and perfumery industry.

More than 2,000 cosmetic companies are active in the European Union, ranging from large multinational organisations to small, often family-run organisations manufacturing for niche markets. The economic impact of the industry is very impressive, and even during the last few difficult years it has enjoyed a period of steady growth. Indeed, the European Union has now overtaken the USA as the largest producer of cosmetics, toiletries and perfumes, with annual retail sales of more than 33 billion ECU (approximately 43 billion dollars) in 1994.

There are around 150,000 people working directly in the manufacturing of cosmetics, and more than 375,000 employed indirectly in areas such as transport, retailing and distribution

An industry so widespread and diverse, manufacturing so many different products and incorporating companies of every size and people of every nationality, could find it difficult to establish common ground or a common viewpoint. How can an industry achieve a united approach in contacts with European authorities, or on the implementation of legislation, when it has conflicting interests?

The answer, in the case of the European cosmetic industry, is Colipa, the European Cosmetic, Toiletry and Perfumery Association.

All companies in this industry are committed to the eventual total elimination of animal testing and safety assessment. However, this can only be achieved when product and ingredient safety for consumers and employees can be equally assured through non-animal alternatives.

The commitment by the cosmetic industry to researching and developing alternatives to animal testing is long established - indeed, since the initiatives undertaken at Johns Hopkins University after World War Two, the industry has been recognised as the leader for many years in the challenging search for alternative methodologies. The numbers of animals used by the cosmetic industry for safety evaluation has been progressively declining for many years. In 1993, it is estimated that the European cosmetic industry accounted for 0.03% of animal tests in the European Union. This reduction in the number of animal tests, together with refinements in the methods used, brings a concurrent reduction in animal suffering, and, more importantly, the reduction in animal testing is expected to continue.

In addition to the potential ban on animal testing in the 6th Amendment to the European Cosmetics Directive, one of the industries strongest initiatives has been the establishment, by teh Colipa International Companies' Council in 1992, of SCAAT, the Steering Committee on Alternatives to Animal Testing. The primary objective of SCAAT is to coordinate the efforts of the industry in the research and development of alternative methodologies.

CONTENTS

The Royal Institute for Sustainable Management of Natural Resources and Promotion of Clean Technology

Speech by HRH Prince Laurent on the Occasion of the Colipa Symposium on Alternative Methods

Welcome Speech
Giorgio Sampietro

Keynote Address
Emma Bonino

Industry at the Forefront of Research
Frank Baker

Alternative Methods: Validation and Safety Assessment
Jacques Leclaire

Opening
Fritz Kemper

The Concept of Validation
Bas J Blaauboer

The Concept of Validation
Leon Bruner

The Molecular Basis of Photoirritation Phenomena
Jose V Castell

Validation Project on Photoirritation Testing in Vitro
Wolfgang Pape

Eye Irritation: The Search For Non-Animal Models
Rodger Curren et al.

Alternatives To Eye Irritation Evaluation - The Industry Perspectives
Odile de Silva

The Challenge of Validation in Europe
Michael Balls et al.

The Challenge of Validation
Mark Chamberlain

Visual Approaches Towards Understanding the Skin Transport Barrier
Harry E Bodde

Percutaneous Absorption: A Strategy For Risk Assessment
Doug Howes

Skin Compatibility - A Dermatological View Of Cosmetic Safety
Ian White

Evaluation of Cosmetic Product Safety without Animal Testing: Use of Dermatological Methods for Assessment of Local Compatibility
Wolfgang Matthies

Critical Cellular and Molecular Events in Skin Sensitization
Conrad Hauser

Contact Sensitization and Predictive Toxicology - Development of Alternative Methods
Jean Luc Garrigue

Safety Assessment of Cosmetics and the Use of Alternatives - A Perspective from the SCC
Nicola Loprieno

Safety Assessment. The Viewpoint of The United Kingdom with Regard to the Regulatory Acceptance of Alternatives (Abstract)
Robin Fielder

Safety Assessment of Cosmetics and the Use of Alternatives: A Perspective from Germany
Eva Schlede et al.

Safety Assessment of Cosmetics and the Use of Alternatives: A Perspective from Industry
Martine Cottin

Round Table Discussion on Future Policy Implications of Alternative Methodologies
Herman Koeter, OECD, France
Yasuo Ohno, National Institute of Health Sciences, Japan
Dagmar Roth-Behrendt, Member of the European Parliament, Germany
Michael Balls, European Centre for the Validation of Alternative Methods (ECVAM), Italy
Maggy Jennings, Royal Society for the Prevention of Cruelty to Animals, UK
Walter De Klerck DG XXIV, European Commission, Belgium
Neil Wilcox, Food and Drug Administration (FDA), USA
Frank Baker, Procter and Gamble, UK
Discussion chaired by Philip Botham, Zeneca, UK,

Alternative Methods to Animal Testing and the Cosmetic and Perfumery Industry
Alain Pompidou

Concluding Speech
Frank A Fairweather

Closing Speech
Robert Vanhove

Biographies

Poster Texts and Abstracts

French Program for the Validation of the In vitro Methods for the Assessment of Local Tolerance of Cosmetic Products
C Amalric et al.

Colipa In Vitro Eye Irritation Programme "Methodology Alternatives" Task Force
D M Bagley et al.

The EC/HO International Validation Study on Alternatives to the Draize Eye Irritation Test
M Balls et al.

Skin Allergy-Identifying the Causative Chemicals: A Strategy to Replace Animal Tests
D A Basketter et al.

The Identification and Classification of Chemicals Causing Skin Irritation: A Strategy to Replace Animal Tests
D A Basketter et al.

Porcine Skin: An Excellent Model to Predict Percutaneous Penetration and Absorption in Humans
H Beck et al.

Percutaneous Absorption / Penetration of Cosmetic Ingredients In Vitro
H Beck et al.

Three Dimensional Cultures of Hepatocytes as Suitable In Vitro Models for Metabolism Studies of Cosmetic Ingredients
S Beken et al.

An Interlaboratory Comparison of Percutaneous Absorption of Sunscreens on Pig Skin In vitro
F Benech Kieffer et al.

Validation of In Vitro Alternative Methods as Replacements for In Vivo Toxicity Tests
L H Bruner et al.

Qualification Of A Battery Of Toxicological Alternative Tests For Skin Care Products
D Castelli et al.

Use of an In vitro Skin Model In Cosmetic Product Development
P L Casterton et al.

An In vitro Cytokine Assay to Discriminate Skin Irritants and Allergens
E Corsini et al.

Ocular Risk Assessment of Cosmetic Formulations using Complementary In Vitro Methodologies and Human Clinical Tests
P Courtellemont et al.

In Vitro Model for Contact Sensitization: Stimulatory Capacities of Human Blood Derived Dendritic Cells and their Phenotypical Alterations in the Presence of Contact Sensitizers
J Degwert et al.

Use of CD 1 a + Dendritic cells and Keratinocytes to Characterize Cellular Reactions Involved in the Allergic Contact Dermititis
J Degwert et al.

Utilization of In Vitro Percutaneous Penetration Data in the Safety Assessment of Hair Dyes
W E Dressler et al.

Implementation of an Animal Test Free Safety Assessment Strategy for Finished Cosmetic Products
R Fautz et al.

The CTFA Evaluation of Alternatives Programme: A Summary of the Results of an Analysis of the Performance of a Series of Promising Alternatives to the Draize Eye Irritation Test
S D Gettings et al.

Corneosurfametry as In vitro Predictive Test for Skin Irritation Potential: Comparison to In Vivo Data
V Coffin et al.

Development of Test Methods for Assessing the Photomutagenic Potential of Sunscreens
L Henderson et al.

Trypsine and Epidermal Cytokines Modulate the Expression of Adhesion and Costimulatory Molecules on Langerhans Cells In Vitro
C Herouet et al.

Inter-Laboratory Validation of Alternative Methods to Eye Irritation Test for Safety Evaluation of Cosmetic Ingredients
H Itagaki et al.

In vitro Primary Sensitization of Hapten-Specific T Cells by Cultured Human Epidermal Langerhans Cells - A Screening Predictive Assay for Contact Sensitizers
M Krasteva et al.

Assay for Alterations of Barrier Function Induced by Chemical Irritants in an In Vitro Model of the Corneal Epithelium Based on a Human Corneal Epithelial Cell Line
F H Kruszewski et al.

Prevalidation of In vitro Methods for Assessment of Phototoxicity and Skin Corrosivity Using the Human Cutaneous Model Skin ZK 1350
M Liebsch et al.

The Use of a Factual Database for the Safety Assessment of Cosmetic Ingredients
C Loprieno

In Vitro Screening Tests used in a Stepwise Eye Irritation Assessment Process
R Osborne et al.

EU/Colipa Validation Project on "In Vitro Photoirritation Testing"
W J W Pape et al.

A Proposed Strategy for the In vitro Detection of Phototoxic Agents
W J W Pape et al.

Icam-1 Expression in Hacat Keratinocytes in Response to Sensitizes and Irritants
N Pineau et al.

II-6, II-8 and Gro-A Production by Hdmvec and Huvec Cells in the Presence of Sensitizers and Irritants
N Pineau et al.

Use of Silastic Membrane for Predicting Vehicle Effects on Dermal Absorption
P Robinson et al.

A Predictive Model for Dermal Penetration
P Robinson

Cosmetic Formulations and Safety -Evaluation of a Battery of Three In Vitro Tests as an Ocular Irritation Screening Method
C Robles et al.

Interlaboratory Assessment of an Alternative Method to the Draize Eye Irritation Test - Preliminary Results from a Multicentre Evaluation of in Vitro Cytotoxicity
C Robles et al.

A Multicentre Study of the Reproducibility and Relevance of Episkin, A Reconstructed Human Epidermis, in the Assessment of Cosmetics Irritancy
R Roguet et al.

Safety Assessment of Cosmetic Ingredients and Products from the Point of View of the Animal Welfare Movement
P Rusche et al

Preliminary Evaluation of a Human Skin Equivalent Model as an in Vitro System to Evaluate the Contact Sensitization Potential of Chemicals
E E Sikorski et al.

An Overview of the Processes Involved in The Evolution and Development of Alternative Test Methods in Europe
JA Southee et al.

The HET-CAM, a Reliable In Vitro Test for the Prediction of Eye Irritation
W Steiling et al.

Metabolism of Arachidonic Acid in the Endothelial and Epithelial Cells of the Cornea Following Treatment by Surfactants
M Tcheng et al.

In Vitro Assessment of Skin Irritation: Evaluation of Mechanism-Based Endpoints and Cytotoxicity In Human and Rabbit Skin Organ Cultures
J J M Van De Sandt

Test Guideline for Assessment of Skin Compatibility of Cosmetic Finished Products in Man
A P Walker

Insert Pore Size Effects on Epithelial Cell Responses to Detergents In Vitro
R K Ward et al.