Alternatives to Animal Testing II

302 Pages  ISBN 1872691129      £15.00

Proceedings of the Second
International Scientific Conference
organised by
The European Cosmetic Industry
Brussels, Belgium, 1999

Introduction
Based on the Keynote Address by Fritz Kemper, Chairman, SCCNFP, European Commission

The proceedings of the Second Colipa Symposium on Alternatives to Animal Testing, a key event in the public debate on animal welfare and public safety requirements, provide a state of the art compilation on the subject just as the 1995 symposium did. This is due to the presence not only of outstanding representatives of the scientific community working both in universities and in industry research laboratories but also of distinguished guests from regulatory bodies and international organisations. The 6^th Amendment of the EU Cosmetics Directive 76/768/EEC requires that all reasonable endeavours be made to develop satisfactory and scientifically validated methods to replace animal testing of cosmetic ingredients. New methods should offer a level of protection of consumer safety equivalent to that provided by the current in vivo tests. The new findings, presented in these proceedings should enable such an assessment to be made.

CONTENTS

Welcome Speeches

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

Welcome Speech
Alan G McGee

Keynote Addresses

Keynote Address
Fritz Kemper

The Cosmetic Industry Commitment to the Research and Development of Alternative Methods: Achievements and Challenges
Jacques Leclaire

Section 1: Alternatives Research in the Cosmetic Industry:
Achievements and Lessons Learned

Photoirritation: The In Vitro 3T3 Neutral Red Uptake Phototoxicity Test (3T3 NRU PT)
Horst Spielmann

Alternative Methods to Eye Irritation: The Way Forward
Odile de Silva

Skin Irritation
Julia H Fentem

Skin Sensitisation
David Basketter

In Vitro Skin Absorption/Penetration
Walter Diembeck

The Use of Human Volunteers
Peter Elsner

Section 2: Alternatives Research:
Viewpoints from Beyond the Cosmetic Industry

Alternatives in Phototoxicity: Multidisciplinary Strategy for Predicting In Vitro the Phototoxic Risk of New Compounds to Man
José V Castell

Alternatives Research in Skin Sensitisation: A Viewpoint From Beyond the Cosmetic Industry
Ian Kimber

Eye Irritation: A View From Beyond the Cosmetic Industry
Monica Berry

Section 3: Cosmetic Product Safety Assessment:
the Role of Alternative Methods

Practical Applications of In Vitro Test Methods for Product Safety Assessment
Leon Bruner

L'Oréal's Alternative Strategy to Evaluate Skin Irritation of Cosmetics
M Cottin, J Jacquin, C Cohen

The Use of Alternative Methods and Clinical Tests in the Ocular Risk Assessment of Cosmetic Formulations
P Courtellemont, M Pannetier, P Perrier, M Pericoi

Practical Applications of In Vitro Test Methods for Product Safety Assessment
Walter Diembeck

Cosmetic Product Safety Assessment in Small and Medium-Sized Enterprises (SMEs)
Marisa Meloni

Cosmetic Product Safety Assessment in a Testing Laboratory
Philippe Masson

Training Product Safety Assessors
Vera Rogiers

Round Table Discussion on the Acceptance of Alternative Methods in the EU
Michael Balls, Lee Bansil, Guy Corcelle, Henk Roelfzema, Jack Dupuis

Section 4: Where Do We Go From Here?

Where Do We Go From Here?
David Wilkins

Alternatives Research and the Role of Animal Welfare Organisations
Marlou Heinen

Where Do We Go From Here?
Robert Vanhove

From Photoirritation to Skin Sensitisation: The Cosmetic Industry's Research Commitment and Plans
Frank W Baker

Round Table Discussion on the Scientific Expectations of Industry and Animal Welfare Lobbyists. Are They Really So Different?
Philip Botham, Vassilios Kapoulas, Hermann Koëter, Michael Balls, Marlou Heinen, Frank Baker

Closing Remarks

Closing Address
David Clark

Farewell Speech
Alan G McGee

Poster Texts and Abstract

Phototoxicity

Discrimination of Photoallergic from Photoirritant Potential using Mechanistic In Vitro Tests
W Lovell

Phototoxicity Testing Using 3D Reconstructed Human Skin Models
P Jones, A King, W Lovell, L Earl

Comet Assay as a Sensitive Approach In Vitro for UVA Photoprotection Assessment
L Marrot, J-P Belaidi, C Agapakis-Caussé

Assessment of Acute UVB Induced Skin Damage in Human Skin Culture
O Doucet, C Robert, B Bertino, M Bonnet, L Zastrow

The Effects of UVA on Human Corneal and Keratinocyte Cell Lines
R Combes, J Manners, P Boavida, M Owen, R Clothier

Report on the In Vitro Red Blood Cell Phototoxicity Test: Evaluation of the Data from Phase II of the Colipa Validation Programme on In Vitro Phototoxicity
W J W Pape, Th Maurer, U Pfannenbecker, W Steiling

A Proposed Strategy for Testing Phototoxicity by Stepwise Use of Validated In Vitro Methodologies: The Colipa Task Force on In Vitro Phototoxicity
W J W Pape, M Balls, M Csato, O de Silva, J Dupuis, G F Gerberick, W W Lovell, M Liebsch, U Pfannenbecker, M Potthast, H Spielmann, W Steiling

Prevalidation of the EpiDerm™ Phototoxicity Test
M Liebsch, D Traue, C Barrabas, H Spielmann, G F Gerberick, L Cruse, W Diembeck, U Pfannenbecker, J Spieker, H-G Holzhütter, P Brantom, P Aspin, J Southee

Development of a Highly Sensitive Phototoxicity Assay Using the Reconstructed Human Epidermis SkinEthic®
F-X Bernard, C Barrault, A Deguercy, B De Wever, M Rosdy

Phototoxicity - An Important Element for the Safety Assessment of Cosmetic Products
W Steiling, W Sterzel

In Vitro Phototoxicity Testing in the Czech Republic
D Jírová, K Kejlová, H Bendová, H Kolárová, R Kubínek, D Ditrichová

Eye Irritation

Investigation of Ingredient Interactions in Cosmetic Formulations Using a Modification of the Bovine Cornea Permeability and Opacity Assay
L H Bruner, M G Evans, J P McPherson, J A Southee, P S Williamson

An In Vitro Human Corneal Model for Ocular Irritancy Testing
M Griffith, X Xiong, N Laycock, M Watsky, R Munger, R Osborne

Evaluation of Corneal Damage in an Ex Vivo Model Using Confocal Microscopy
G L Rutschilling, D A Roberts, G M Ridder, J K Maurer, R Osborne

A Stepwise Eye Irritation Assessment Process for Cosmetics
R Osborne, A Ghassemi, L H Bruner

An In Vitro Assessment of the Eye Irritation Potential of New Shampoo Formulations
P Jones, D Basketter

Histopathology Aids Ocular Irritancy Assessment of Cosmetic Ingredients Using Bovine Corneas In Vitro
J W Harbell, H A Raabe, M G Evans, R D Curren

Successful Use of a Battery of In Vitro Tests to Screen for Ocular Safety Before Human Trials
R Grabarz, R Sharma, W Dressler, J Harbell, H Raabe, R Curren

Reconstituted Human Epithelial Cultures: A Possible Alternative to the Draize Eye Irritation Test for Assessing the Irritating Potential of Cosmetic Products
O Doucet, M Lanvin, L Zastrow

The Bovine Corneal Opacity and Permeability Assay: The Relationship of Opacity to Corneal Hydration, Structure and Endothelial Damage
J L Ubels, P L Casterton, R L Pruis, J Swets

A Proposed Classification Scheme for Chemical Injury to the Human Eye
H F Edelhauser, J P McCulley, R B Nussenblatt

Preliminary Evaluation of the Application of Reference Standards in the Prevalidation and Validation of In Vitro Tests for Eye Irritation
M Balls, P G Brantom, S Cassidy, D Esdaile, J Fentem, M Liebsch, J McPherson, U Pfannenbecker, M Prinsen

A Tiered In Vitro/In Vivo Testing Strategy to Classify Severely Eye Irritating Chemicals Using Two Alternatives to the Draize Eye Test, the HET-CAM Test and the 3T3 NRU Cytotoxicity Test
H Spielmann, M Liebsch, S Kalweit, F Moldenhauer, T Wirnsberger, H-G Holzhütter, B Schneider, S Glaser, I Gerner, W J W Pape, R Kreiling, K Krauser, H G Miltenburger, W Steiling, N P Luepke, P Günzel, N Müller, H Kreuzer, P Mürmann, J Spengler, E Bertram-Neis, B Siegemund, F J Wiebel

Colipa Validation Project on In Vitro Eye Irritation Tests for Cosmetic Ingredients and Finished Products (Phase I): The Red Blood Cell Test for the Estimation of Acute Eye Irritation Potential - The Present Status
W J W Pape, U Pfannenbecker, H Argembeaux, M Bracher, D J Esdaile, S Hagino, Y Kasai, R W Lewis

Skin Sensitisation

Modulation of 33D1 Expression on Mature Murine Langerhans Cells by Contact Sensitisers
C Hérouet, M Cottin, J Leclaire, F Rousset

Cytokine mRNA Expression by Human Blood Derived Dendritic Cells: An In Vitro End Point for Contact Sensitisation?
J S Pichowski, M Cumberbatch, R J Dearman, D A Basketter, I Kimber

Colipa Skin Sensitisation Task Force Project: The Role of Skin Metabolism in Prohapten Activation and Hapten Detoxification
C K Smith, S A M Hotchkiss

Skin Irritation

The Determination of Acute Chemically Induced Skin Irritation Using a Human Skin Model
L K Earl, T J Hall-Manning, G H Holland

Prevalidation of In Vitro Tests for Acute Skin Irritation
J Fentem, P Botham, L Earl, R Roguet, J van de Sandt

Prevalidation of the Epiderm™ Skin Corrosivity Test
M Liebsch, D Traue, C Barrabas, H Spielmann, P Uphill, S Wilkins, J McPherson, C Wiemann, T Kaufmann, M Remmele, H-G Holzhütter, P Brantom, P Aspin, J Southee

Episkin®: An In Vitro System to Assess the Irritative Potential of Chemicals
C Cohen

Skin Compatibility Testing on Human Volunteers Using Squamometry
M Paye, V Charbonnier, B M Jr Morrison, H I Maibach

Skin Penetration

In Vivo and In Vitro Percutaneous Absorption of Alpha Hydroxy Acids
D J Sanders, H J Minter, R U Pendlington, D Howes

Potential of Skin Culture Models for Assessing In Vitro Percutaneous Absorption
O Doucet, N Garcia, L Zastrow

In Vitro Percutaneous Absorption Studies: Interlaboratory Reproducibility of the Pig Ear Skin Model
F Hueber, E Teillaud, F Ouvrard-Baraton, J P Biesse, P Courtellemont, C M Vincent, J-P Marty

Comparison of In Vitro Cutaneous Permeation of Three Xenobiotics through Pig Skin and Human Skin
M N Python, H Beck, M Bracher

In Vitro Absorption and Penetration of UV Filters on Fresh Excised Pig Skin
M Torres Fernández, H-J Duesing, J L Parra Juez, W Diembeck

The Stripping Technique: In Vivo and In Vitro Absorption and Distribution of Five UV Filters in Human Stratum Corneum
G Potard, H Schaefer, J-P Marty

General

The Belgian Platform for Alternative Methods (BPAM)
S Beken, V Rogiers

An In Vitro Model Aimed to Detect the Immunoprotective Effect of Sunscreens
P Courtellemont, C Sauvage, C Dalbiez-Gauthier, J Peguet-Navarro, D Schmitt

Organisational Structure for In Vitro Toxicological Work: ECVAM (^glpOLIV^toxE^©JRC)
S Coecke, G Bowe, M Balls

Testing and Improvement of Reconstructed Skin Kits in Order to Elaborate European Standards
R Rouget, H Beck, E Boelsma, M Bracher, C Faller, I Harris, C Lotte, M Ponec

In Vitro Testing Industrial Platform (IVTIP)
W P Hermans

Annexes

Biographies

Author Index