Addendum to In Vitro Ocular Toxicity
Draft Background Review Documents

July 25, 2005

1. Isolated Rabbit Eye (IRE) Accuracy and Reliability Reanalysis [PDF]
   
   
   1. Introduction
      
      
   2. Accuracy of the IRE Test Method - Reanalysis
      
      
   3. Reliability of the IRE Test Method - Reanalysis
      
      
   4. References
      
      
   5. Appendix I-A: Substances Used in IRE Test Method Reanalysis [PDF]
      
      
      
2. Isolated Chicken Eye (ICE) Accuracy and Reliability Reanalysis [PDF ]
   
   
   1. Introduction
      
      
   2. Accuracy of the ICE Test Method - Reanalysis
      
      
   3. Reliability of the ICE Test Method - Reanalysis
      
      
   4. References
      
      
   5. Appendix II-A: Substances Used in ICE Test Method Reanalysis [PDF]
      
      
      
3. Bovine Corneal Opacity and Permeability (BCOP) Accuracy and Reliability Reanalysis [PDF ]
   BCOP Chemical/Physical Class Exclusion Analysis [PDF] (8/30/2005)
   Note: In this spreadsheet, NICEATM performed an analysis which removed alcohols, ketones, and solids (separately and in combination) to see what impact each of these classes had on the overall BCOP accuracy rate.
   
   
   1. Introduction
      
      
   2. Accuracy of the BCOP Test Method - Reanalysis
      
      
   3. Reliability of the BCOP Test Method - Reanalysis
      
      
   4. References
      
      
   5. Appendix III-A: Substances Used in BCOP Test Method Reanalysis [PDF]
      
      
      
4. Hen's Egg Test - Chorioallantoic Membrane (HET-CAM) Accuracy and Reliability Reanalysis [PDF ]
   Correction to Addendum Table IV-8 (8/17/2005) [PDF]
   
   
   1. Introduction
      
      
   2. Accuracy of the HET-CAM Test Method - Reanalysis
      
      
   3. Reliability of the HET-CAM Test Method - Reanalysis
      
      
   4. References
      
      
   5. Appendix IV-A: Substances Used in HET-CAM Test Method Reanalysis [PDF]
      
      
      
5. Revised Proposed Reference Substances for Optimization/Validation Studies [PDF ]
   
   
   1. Introduction
   
   
   
   2. Revised List of Proposed References
      
      
   3. References
      
      
   • Appendix V-A: Candidate Substances for the List of Proposed Reference Substances for Validation Studies of In Vitro Test Methods for the Identification of Ocular Corrosives/Severe Irritants
     
     
     • A-1: Sorted by CASRN [PDF] - [References]
       
       
     • A-2: Sorted by GHS Ocular Hazard Category and Substance Name [PDF] - [References]
       
       
   • Appendix V-B: List of Proposed Reference Substances for Validation Studies of In Vitro Test Methods for the Identification of Ocular Corrosives/ Severe Irritants
     (Sorted by Chemical Class, GHS Ocular Hazard Classification Category, and Substance Name) [PDF] - [References]
     
     
   • Appendix V-C: List of Proposed Reference Substances for Validation Studies of In Vitro Test Methods for the Identification of Ocular Corrosives/ Severe Irritants
     (Sorted by Product Class, GHS Ocular Hazard Classification Category, and Substance Name) [PDF]
     
     
   • Appendix V-D: List of Proposed Reference Substances for Validation Studies of In Vitro Test Methods for the Identification of Ocular Corrosives/ Severe Irritants
     (Sorted by Product Class, GHS Ocular Hazard Classification Category, and Substance Name) [PDF]
     
     
     

Appendix A: NICEATM-Defined Retrospective In Vivo Ocular Irritancy Classification Rules [PDF]

Appendix B: Glossary of NICEATM-Defined Chemical Classes [PDF]