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Alternative Methods in Toxicology

Volume 5 - In Vitro Toxicology: Approaches to Validation

Series Editor: ALAN M. GOLDBERG

Mary Ann Liebert, Inc. | Publishers

Table of Contents

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
  1. Validation Studies on a Battery of Potential In Vitro Alternatives to the Draize Test
     Charles Shopsis, Ellen Borenfreund, and Dennis M. Stark
  2. 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
  3. The Development and Evaluation of the Chorioallantoic Membrane (CAM) Assay
     Betty M. Kong, Chris J. Viau, Perveen Y. Rizvi, and Salvatore J. De Salva
  4. 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
  5. Validation of an In Vitro Eye Irritancy Test: A First Step
     Herman B.W.M Koeter and Menk K. Prinsen
  6. The Validation Approach of The Johns Hopkins Center for Alternatives to Animal Testing
     John M. Frazier
• Skin and Eye Studies in Progress
  1. Chairman's Remarks
     Direct Toxicity to the Cornea: A Nonspecific Process?
     David Maurice
  2. Introductory Lecture: Mechanisms of Inflammation in Skin and Eyes - Similarities and Differences
     Michael B. Berman
  3. 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
  4. Surfactant-Induced Cutaneous Primary Irritancy: An In Vitro Model
     Vincent A. DeLeo, Lauren Midlarsky, Leonard C. Harber, Betty M. Kong, and Salvatore De Salva
  5. Corneal Epithelial Wound Closure: A Tissue Culture Model of Ocular Irritancy
     Marcia M. Jumblatt, Sandra J. Simmons, and Arthur H. Neufield
  6. Further Testing of an In Vitro Phototoxicity Assay
     Irene E. Kochevar, Andre Western, and Daniel J. McAuliffe
  7. Novel Strategies for Evaluating the Comparative Toxicity of Unmodified Viscoelastic Formulations
     Dale R. Meyer and James P. McCulley
  8. 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
  1. The Economic Viability of In Vitro Testing Techniques
     Henry R. Hertzfield and Thomas D. Meyers
  2. Alternatives - A Kaleidoscope of Perspectives
     Andrew N. Rowan

Part 2: Poster Presentations

1. 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
2. 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
3. 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
4. Use of Stimulated Oxygen Consumption as a Measure of Cutaneous Perturbation
   M.G. Bird, G. Witz, R.A. Scala, and D.V. Parke
5. Differential Response of In Vitro Vaginal Tissue to Various Test Agents
   N.H. Dubin, R.B. Ghodgaonkar, and T.H. Parmley
6. In Vitro Detection of Cornea-Derived Leukocytic Chemotactic Factors as Indicators of Corneal Inflammation
   Salwa A. Elgebaly, Fairpour Forouhar, and Donald L. Kreutzer
7. Some problems in Validating Cytotoxicity as a Correlate of Ocular Irritancy
   Christopher Flower
8. 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
9. EYTEX, An In Vitro Method for Evaluation of Ocular Irritancy
   V.C. Gordon and H.C. Bergman
10. 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
11. Incorporation of Species Differences in Metabolism into In Vitro Teratogenicity Testing
    Barbara F. Hales
12. 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
13. 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
14. 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
15. Chemical Structure - Transport Rate Relationships for Model Skin Lipid Membranes
    Joy Houk, Corwin Hansch, Larry L. Hall, and Richard H. Guy
16. HET-CAM - Reproducibility Studies
    Niels-P. Luepke and Siegfried Wallat
17. A New Teratogenic Risk Assessment Bioassay System Utilizing Marine Hydrozoans
    Vicki J. Martin
18. Evaluation of the Comparative Toxicity of Intraocular Viscoelastic Preparations
    Dale R. Meyer and James P.McCulley
19. Cisplatinum Toxicity in Rabbit Renal Proximal Tubule Suspensions and Precision-Cut Renal Cortical Slices
    J.S. Phelps, A.J. Gnadolfi, and K. Brendel
20. In Vitro Enzymatic Toxicity Test Model Validity Approach
    K.S. Jagannatha Rao
21. Use of Cultured Human Cells as Screeing Models for Antipsoriatic Drugs
    Uwe Reichert, Alain Chatelus, and Gerard Pautrat
22. 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
23. 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
24. 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
25. Ocular Lens Organ Culture System for In Vitro Toxicology
    J.G. Sivak, D. Gershon, A. Dovrat, and J. Weerheim
26. Clonal Cultures of RPE Cells as Sensitive Indicators of Agents Affecting Terminal Differentiation
    Sabine H.H. Swierenga, Ursula Vielkind, and Fai Lee
27. Validation of the Becam Assay - An Eye Irritancy Screening Test
    Peter J.J.M. Weterings and Yvette H.M. van Erp