In Vitro Toxicology Approaches to Validation
Preface
Acknowledgements
Contributing Authors
Part One: Symposium Presentations
Theoretical Approaches to Validation
Robert A. Scala
Validation as Applied to In Vitro Toxicology
John O. Rundell
The Interplay Among Validation, Policy, and Regulation
Richard N. Hill
Diffusion of a New Methodology
Frank Baker
Validation Studies in Progress
Validation Studies on a Battery of Potential In Vitro Alternatives to the Draize Test
Charles Shopsis, Ellen Borenfreund, and Dennis M. Stark
The FRAME Approach to the Development, Validation, and Evaluation of In Vitro Alternatives Methods
Michael Balls, Rosemary J. Riddell, Steven A. Horner, and Richard H. Clothier
The Development and Evaluation of the Chorioallantoic Membrane (CAM) Assay
Betty M. Kong, Chris J. Viau, Perveen Y. Rizvi, and Salvatore J. De Salva
An Approach to Validation: Comparison of Six Materials in Three Tests
John A. Shadduck, James Render, Jeffrey Everitt, Rose Ann Meccoli, and Diane Essex-Sorlie
Validation of an In Vitro Eye Irritancy Test: A First Step
Herman B.W.M Koeter and Menk K. Prinsen
The Validation Approach of The Johns Hopkins Center for Alternatives to Animal Testing
John M. Frazier
Skin and Eye Studies in Progress
Chairman’s Remarks
Direct Toxicity to the Cornea: A Nonspecific Process?
David Maurice
Introductory Lecture: Mechanisms of Inflammation in Skin and Eyes – Similarities and Differences
Michael B. Berman
Two New In Vitro Methods for Evaluating Toxicity to Skin (Employing Short-Term Organ Culture): I. Paranuclear Vacuolization, Seen in Glycol Methacrylate Tissue Sections; II. Inhibition of 14C-Leucine Incorporation
Arthur M. Dannenberg, Jr., K. Gregory Moore, Brian H. Schofield, Kazuyuki Higuchi, Akira Kajiki, Kin-Wing Au, Peggy J. Pula, and David P. Bassett
Surfactant-Induced Cutaneous Primary Irritancy: An In Vitro Model
Vincent A. DeLeo, Lauren Midlarsky, Leonard C. Harber, Betty M. Kong, and Salvatore De Salva
Corneal Epithelial Wound Closure: A Tissue Culture Model of Ocular Irritancy
Marcia M. Jumblatt, Sandra J. Simmons, and Arthur H. Neufield
Further Testing of an In Vitro Phototoxicity Assay
Irene E. Kochevar, Andre Western, and Daniel J. McAuliffe
Novel Strategies for Evaluating the Comparative Toxicity of Unmodified Viscoelastic Formulations
Dale R. Meyer and James P. McCulley
A Simple Fluorometer for Use with a Permeability Screen for Immediate Ocular Toxicity
Darrell Brooks and David Maurice
Special Lecture
Development and Validation of an Alternative Test for the Detection of Embryonic Malformations: The Postimplantation Embryo Culture Test (PECT)
Beat P. Schmid and L. Cicurel
Conclusions
The Economic Viability of In Vitro Testing Techniques
Henry R. Hertzfield and Thomas D. Meyers
Alternatives – A Kaleidoscope of Perspectives
Andrew N. Rowan
Part 2: Poster Presentations
Cellular Uptake and Response of Primary Cultures of Rabbit Renal Proximal Tubule Cells Exposed to Mercuric Chloride and Methylmercury Chloride
Michael D. Aleo, Mary L. Traub, James R. Olsen, Peter A. Nickerson, and Paul J. Kostyniak
The Use of Primary Hepatocyte Cultures to Detect the Induction of Hepatic Alkaline Phosphate Enzyme in the Rat
David E. Amacher and Donna J. Smith
Occular Irritancy Evaluated In Vivoby Conjunctival Lavage Technique and In Vitro by Bovine Eye Cup Model
C.A. Benassi, M.R. Angi, L. Salvalaio, and A. Bettero
Use of Stimulated Oxygen Consumption as a Measure of Cutaneous Perturbation
M.G. Bird, G. Witz, R.A. Scala, and D.V. Parke
Differential Response of In Vitro Vaginal Tissue to Various Test Agents
N.H. Dubin, R.B. Ghodgaonkar, and T.H. Parmley
In Vitro Detection of Cornea-Derived Leukocytic Chemotactic Factors as Indicators of Corneal Inflammation
Salwa A. Elgebaly, Fairpour Forouhar, and Donald L. Kreutzer
Some problems in Validating Cytotoxicity as a Correlate of Ocular Irritancy
Christopher Flower
Development, Validation, and Transfer of a New Test System Technology in Toxicology
Shayne C. Gad, Brendan J. Dunn, Frances A. Gavigan, Christopher Reilly, and Robert D. Walsh
EYTEX, An In Vitro Method for Evaluation of Ocular Irritancy
V.C. Gordon and H.C. Bergman
Empirical and Experimental Bases for Selecting the Low Volume Rabbit Eye Irritation Test as the Validation Standard for In Vitro Methods
J.F. Griffith and F.E. Freeberg
Incorporation of Species Differences in Metabolism into In Vitro Teratogenicity Testing
Barbara F. Hales
Influence of Reduced Numbers of Rabbits on the Adequacy of Eye Irritancy Tests
N.S. Hatoum, C.L. Leach, R.D. Gibbons, D.M. Talsma, J-C. Roger, and P.J. Garvin
In Vitro Methods for Assessing Cytotoxicty of Contact Lenses – Comparison with In VivoData
C. Hecquet, X. Ronot, L. Le Naour, J.G. Josse, and M. Adolphe
Intralaboratory Replication of Results Obtained in the Hydra Developmental Toxicity Screen
Alan M. Hoberman, Eric W. Sica, Mildred S. Christian, Betty M. Kong, and Frederick R. Kirchner
Chemical Structure – Transport Rate Relationships for Model Skin Lipid Membranes
Joy Houk, Corwin Hansch, Larry L. Hall, and Richard H. Guy
HET-CAM – Reproducibility Studies
Niels-P. Luepke and Siegfried Wallat
A New Teratogenic Risk Assessment Bioassay System Utilizing Marine Hydrozoans
Vicki J. Martin
Evaluation of the Comparative Toxicity of Intraocular Viscoelastic Preparations
Dale R. Meyer and James P.McCulley
Cisplatinum Toxicity in Rabbit Renal Proximal Tubule Suspensions and Precision-Cut Renal Cortical Slices
J.S. Phelps, A.J. Gnadolfi, and K. Brendel
In Vitro Enzymatic Toxicity Test Model Validity Approach
K.S. Jagannatha Rao
Use of Cultured Human Cells as Screeing Models for Antipsoriatic Drugs
Uwe Reichert, Alain Chatelus, and Gerard Pautrat
Validation of Three Cell Toxicity Tests and the Hen’s Egg Test with Guinea Pig Eye and Human Skin Irritation Data
Christoph A. Reinhardt, Martin Aeschbacher, Max Bracher, and Jochen Spengler
Evaluating the Percutaneous Absorption of Polynuclear Aromatics Using In Vivoand In Vitro Techniques and Structure Activity Relationships
Timothy A. Roy, Joseph J. Yang, and Maria H. Czerwinski
A Comparison of the Toxicity of the Acrylamide, Cyclophosphamide, Chlordecone, and Diethylstilbestrol in Chinese Hamster Ovary (CHO) Cells with Their Toxicity In Vivo
Jane Ellen Simmons, Marcus Jackson, Joellen Lewtas, and Ezra Berman
Ocular Lens Organ Culture System for In Vitro Toxicology
J.G. Sivak, D. Gershon, A. Dovrat, and J. Weerheim
Clonal Cultures of RPE Cells as Sensitive Indicators of Agents Affecting Terminal Differentiation
Sabine H.H. Swierenga, Ursula Vielkind, and Fai Lee
Validation of the Becam Assay – An Eye Irritancy Screening Test
Peter J.J.M. Weterings and Yvette H.M. van Erp