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In Vitro Test Methods for Detecting Ocular Corrosives and Severe Irritants
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Background Review Document for BCOP BRD

BCOP BRD in PDF [6.0 MB, 206 pages]

Table of Contents
List of Tables
List of Figures
Acronyms and Abbreviations
Acknowledgements
Preface
Executive Summary
 BCOP BRD Cover
  1. Introduction and Rationale for the Proposed Use of In Vitro Test Methods to Identify Ocular Corrosives and Severe Irritants [PDF]

  2. BCOP Test Method Protocol Components [PDF]

  3. Substances Used for Validation of the BCOP Test Method [PDF]

  4. In Vivo Reference Data Used for an Assessment of Test Method Accuracy [PDF]

  5. BCOP Test Method Data and Results [PDF]

  6. BCOP Test Method Accuracy [PDF]

  7. BCOP Test Method Reliability [PDF]

  8. BCOP Test Method Data Quality [PDF]

  9. Other Scientific Reports and Reviews [PDF]

  10. Animal Welfare Considerations [PDF]

  11. Practical Considerations [PDF]

  12. References [PDF]

  13. Glossary [PDF]

Appendices in PDF [10.1 MB, 548 pages]
  • Appendix A - Publicly Available Protocols for the BCOP Test Method [PDF]

    • A1 - INVITTOX Protocol 98. The Bovine Corneal Opacity and Permeability Assay Method of Gautheron [PDF]

    • A2 - INVITTOX Protocol 124. Bovine Corneal Opacity and Permeability (BCOP) Assay SOP of Microbiological Associates Ltd., United Kingdom [PDF]

    • A3 - Table of BCOP Protocols from the Reviewed Literature [PDF]

  • Appendix B - Characterization of the Substances Tested in the BCOP Test Method [PDF]

    • B1 - Chemical and Product Classes of Substances Tested in the BCOP Assay [PDF]

    • B2 - Components of Formulations Tested in Gettings et al. (1996) [PDF]

    • B3 - Components of Formulations Tested in Swanson et al. (1995) [PDF]

    • B4 - Components of Formulations Tested in Swanson and Harbell (2000) [PDF]

  • Appendix C - In Vitro Data for Substances Tested in the BCOP Assay [PDF]

    • C1 - BCOP Data Sorted by Reference [PDF]

    • C2 - BCOP Data Sorted by Substance Name [PDF]

  • Appendix D - Comparison of In Vivo and In Vitro Ocular Irritancy Classifications [PDF]

    • D1 - BCOP Data Sorted by Reference [PDF]

    • D2 - BCOP Data Sorted by Substance Name [PDF]

  • Appendix E - Intralaboratory Coefficient of Variation (CV) Analysis of BCOP [PDF]

    • E1 - BCOP Data from Southee 1998 [PDF]

    • E2 - BCOP Data from Dr. Joseph Sina [PDF]

    • E3 - BCOP Data from Dr. Freddy Van Goethem [PDF]

  • Appendix F - Interlaboratory Correlation Coefficients from the EC/HO Validation Study (Balls et al., 1995) [PDF]

  • Appendix G - Additional BCOP Studies [PDF]
    Received in Response to Federal Register Notices (Vol. 69, No. 57, pp. 13859-13861) and (Vol. 70, No. 38, pp. 9661-9662)


    • G1 - Dataset Received from S.C. Johnson & Son, Inc. in Support of Cuellar et al. (2004) Poster Presentation [PDF]

    • G2 - Dataset Received from S.C. Johnson & Son, Inc. in Support of Cuellar et al. (2002) Poster Presentation [PDF]

    • G3 - Dataset Received from S.C. Johnson & Son, Inc. in Support of Gran et al. (2003) Poster Presentation [PDF]

    • G4 - Dataset Received from L'OREAL Advanced Research for an In-house Porcine Corneal Opacity and Permeability Assay [PDF]

    • G5 - Supporting Analyses Received from IIVS for Gettings et al. (1996) Study [PDF]

    • G6 - Dataset Received from Johnson & Johnson Pharmaceutical Research and Development - A Division of Janssen Pharmaceutica N.V. (Laboratory No. 9 in Gautheron et al. 1994) [PDF]

    • G7 - Dataset Received from Johnson & Johnson Pharmaceutical Research and Development - A Division of Janssen Pharmaceutica N.V. (BCOP Tests With Young vs. Old Corneas) [PDF]
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