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In Vitro Test Methods for Detecting Ocular Corrosives and Severe Irritants

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Background Review Document for Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Test

HET-CAM BRD in PDF [6.6 MB, 248 pages]

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

  2. Test Method Protocol Components [PDF]

  3. Substances Used for Validation of the HET-CAM Test Method [PDF]

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

  5. Test Method Data and Results [PDF]

  6. Test Method Accuracy [PDF]

  7. Test Method Reliability [PDF]

  8. 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 [6.8 MB, 430 pages]
  • Appendix A - Publicly Available Protocols for the HET-CAM Test Method [PDF]

    • A1 - INVITTOX Protocol 47. The HET-CAM Test - Method of Spielmann and Liebsch [PDF]

    • A2 - Table of HET-CAM Protocols from the Reviewed Literature Used to Assess Ocular Irritancy [PDF]

  • Appendix B - Chemical and Product Class Information for the Substances Tested in the HET-CAM Test Method [PDF]

    • B1 - Table of Chemical and Product Class Information

    • B2 - Table of Formulation Components in Gettings et al. (1991)

    • B3 - Table of Formulation Components in Gettings et al. (1994)

    • B4 - Table of Formulation Components in Gettings et al. (1996)

  • Appendix C - In Vitro Data for Substances Tested in the HET-CAM Test Method [PDF]

    • C1 - Test Method Protocols used to Generate In Vitro Data [PDF]

    • C2 - Data Sorted by Reference [PDF]

    • C3 - Data Sorted by Substance Name for IS(A) Analysis Method [PDF]

    • C4 - Data Sorted by Substance for IS(A)-10 Analysis Method [PDF]

    • C5 - Data Sorted by Substance for IS(A)-100 Analysis Method [PDF]

    • C6 - Data Sorted by Substance for IS(B) Analysis Method [PDF]

    • C7 - Data Sorted by Substance for IS(A)-10 Analysis Method [PDF]

    • C8 - Data Sorted by Substance for IS(A)-100 Analysis Method [PDF]

    • C9 - Data Sorted by Substance for Q-Score Analysis Method [PDF]

    • C10 - Data Sorted by Substance for S-Score Analysis Method [PDF]

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

    • D1 - Data Sorted by Reference [PDF]

    • D2 - Data Sorted by Substance for IS(A) Analysis Method [PDF]

    • D3 - Data Sorted by Substance for IS(A)-10 Analysis Method [PDF]

    • D4 - Data Sorted by Substance for IS(A)-100 Analysis Method [PDF]

    • D5 - Data Sorted by Substance for IS(B) Analysis Method [PDF]

    • D6 - Data Sorted by Substance for IS(B)-10 Analysis Method [PDF]

    • D7 - Data Sorted by Substance for IS(B)-100 Analysis Method [PDF]

    • D8 - Data Sorted by Substance for Q-Score Analysis Method [PDF]

    • D9 - Data Sorted by Substance for S-Score Analysis Method [PDF]

  • Appendix E - Intralaboratory Repeatability and Intralaboratory Reproducibility Data and Results for Gilleron et al. (1996, 1997) [PDF]

    • E1 - Individual Egg HET-CAM Scores (Endpoints Evaluated and Overall Irritancy) for Data of Gilleron et al. (1996) [PDF]

    • E2 - Individual Egg HET-CAM Scores (Endpoints Evaluated and Overall Irritancy) for Data of Gilleron et al. (1997) [PDF]

    • E3 - Intralaboratory Repeatability Results (Expressed as %CV) for Data of Gilleron et al. (1996) [PDF]

    • E4 - Intralaboratory Repeatability Results (Expressed as %CV) for Data of Gilleron et al. (1997) [PDF]

    • E5 - Intralaboratory Reproducibility Results (Expressed as %CV) for Data of Gilleron et al. (1996) [PDF]

    • E6 - Intralaboratory Reproducibility Results (Expressed as %CV) for Data of Gilleron et al. (1997) [PDF]

  • Appendix F - Interlaboratory Reproducibility Data [PDF]

    • F1 - Individual HET-CAM Test Laboratory Data for CEC (1991) [PDF]

    • F2 - Average HET-CAM Scores and Coefficient of Variations for Substances Evaluated in Hagino et al. (1999) and Ohno et al. (1999) [PDF]

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

  • Appendix H - Positive Control Data [PDF]

    • H1 - Individual HET-CAM Egg Data for Dimethylformamide (provided by Drs. Vanparys and van Goethem) [PDF]

    • H2 - Individual HET-CAM Egg Data for Imidazole (provided by Drs. Vanparys and van Goethem) [PDF]

    • H3 - Individual HET-CAM Egg Data for Sodium Dodecyl Sulfate and Sodium Hydroxide (provided by Drs. Spielmann and Liebsch) [PDF]

  • Appendix I - Individual HET-CAM Scores for Eggs Treated with 0.9% Sodium Chloride [PDF]


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