Return to Nonanimal Assessment Approach for Evaluating Eye Irritation
Potential of Antimicrobial Cleaning Products page
Return to In Vitro Test Methods for Detecting Nonsevere Ocular Irritants page
Return to Effects of Topical Anesthetic Pretreatment on
In Vivo Ocular Irritation Hazard Classification page
NICEATM, in collaboration with ICCVAM, will
convene an public meeting of an independent scientific peer review panel on
alternative ocular safety testing methods. Topics to be considered by the
Panel include:
- The validation status of a testing strategy that proposes the use of three in vitro test methods to assess eye irritation
potential of antimicrobial cleaning products
- The validation status of four in vitro test methods for identifying moderate and mild irritants and substances not classified as ocular irritants
- The validation status of the in vivo low volume eye test
- A proposal for the routine use of topical anesthetics, systemic analgesics, and humane endpoints to
avoid and minimize pain and distress during in vivo ocular irritation testing
Announcement of an Independent Scientific Peer Review Panel on Alternative Ocular Safety Testing Methods; Availability of Draft Background Review Documents (BRD); Request for Comments
|
View Federal Register Notice
(Vol. 74, No. 60, pages 14556-14557, March 31, 2009) [PDF] |
|
Information for those interested in attending the Peer Panel meeting |
|
|
Documents to be Reviewed by the Ocular Peer Review Panel
Draft Proposed ICCVAM Test Method Recommendations: Evaluation of the Validation Status of
Alternative Ocular Safety Testing Methods and Approaches
[PDF]
Draft Background Review Document: Use of Topical Anesthetics, Systemic Analgesics, and Earlier Humane Endpoints to Minimize Pain and Distress in Ocular Toxicity Testing
Background Review Document with all appendices (87 pages) [PDF]
References for Use of Anaesthesia and Analgesia in In Vivo Ocular Hazard Testing
Draft Background Review Document: The Low Volume Eye Test
- Main Body (32 pages) [PDF]
- Appendix A: Low Volume Eye Test (LVET) A.I.S.E. Submission To ECVAM - Technical Dossier, February 2007
This document was originally submitted to the European Centre for the Validation of
Alternative Methods (ECVAM). Because this document forms part of the basis for one or more
draft ICCVAM test method recommendations, NICEATM has requested authorization from ECVAM to
make this document publicly available. A decision by ECVAM on this issue is currently pending
and therefore this document is not attached.
References for the Low Volume Eye Test
Draft Summary Review Document: Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification
and Labeling of Antimicrobial Cleaning Products Using In Vitro Alternative Test Methods
- Main Body (78 pages) [PDF]
- Appendix A: Background Review Document (BRD) of an In Vitro Approach for EPA Toxicity Labeling of Anti-Microbial Cleaning Products
View webpage with appendix contents
- Appendix B: ECVAM BRD Submission - The Low Volume Eye Test
- Appendix C: ECVAM BRD Submission - Cytosensor Microphysiometer
- Appendix D: ECVAM BRD Submission - EO OCL-200 Model for Assessing Eye Irritation of Surfactants and Surfactant-Based Formulations
The documents for Appendices B, C, and D were originally submitted to the European Centre for the Validation of
Alternative Methods (ECVAM). Because these documents form part of the basis for one or more
draft ICCVAM test method recommendations, NICEATM has requested authorization from ECVAM to
make these documents publicly available. A decision by ECVAM on this issue is currently pending
and therefore these documents are not attached.
- Appendix E: ICCVAM Background Review Document - Current Status of In Vitro
Test Methods for Identifying Ocular Corrosives and Severe Irritants: Bovine Corneal
Opacity and Permeability Test Method (206 pages) [PDF]
- Appendix F: Physicochemical Properties of Substances Evaluated in the AMCP BRD (4 pages) [PDF]
- Appendix G: Data Used for the Performance Analysis of the AMCP BRD (2 pages) [PDF]
References for the Classification of Antimicrobial Cleaning Products Using In Vitro Alternative Test Methods
Draft Background Review Documents: Current Status of In Vitro Test Methods for Identifying Mild/Moderate Ocular Irritants
The Isolated Chicken Eye (ICE) Test Method
- Main Body (102 pages) [PDF]
- Appendix A: Chemical and Product Class Information for the Substances Tested in the ICE Test Method (10 pages)
[PDF]
- Appendix B: In Vitro Data for Substances Tested in the ICE Test Method
- B1 - ICE Data Sorted by Reference [XLS]
- B2 - ICE Data Sorted by Substance Name [XLS]
- Appendix C: In Vivo and In Vitro Comparison of Ocular Irritancy Classification
- C1 - ICE Data Sorted by Reference [XLS]
- C2 - ICE Data Sorted by Substance Name [XLS]
References for the ICE Test Method
The Bovine Corneal Opacity and Permeability (BCOP) Test Method
- Main Body (131 pages) [PDF]
- Appendix A: Characterization of the Substances Tested in the BCOP Test Method
- A1 - Chemical and Product Classes of Substances Tested in the BCOP Assay [XLS]
- A2 - Components of Formulations Tested in Gettings et al. (1996) [XLS]
- A3 - Components of Formulations Tested in Swanson et al. (1995) [XLS]
- A4 - Components of Formulations Tested in Swanson and Harbell (2000) [XLS]
- A5 - Components of AMCP Formulations Tested in Swanson [XLS]
- Appendix B: In Vitro Data for Substances Tested in the BCOP Test Method
- B1 - BCOP Data Sorted by Reference [XLS]
- B2 - BCOP Data Sorted by Substance Name [XLS]
- Appendix C: In Vivo and In Vitro Comparison of Ocular Irritancy Classification
- C1 - BCOP Data Sorted by Reference [XLS]
- C2 - BCOP Data Sorted by Substance Name [XLS]
References for the BCOP Test Method
The Hen’s Egg Test – Chorioallantoic Membrane (HET-CAM) Test Method
- Main Body (119 pages) [PDF]
- Appendix A: Chemical and Product Class Information for the Substances Tested in the HET-CAM Test Method (46 pages)
[PDF]
- Appendix B: In Vitro Data for Substances Tested in the HET-CAM Test Method
- B1 - Test Method Protocols used to Generate In Vitro Data [XLS]
- B2 - Data Sorted by Reference [XLS]
- B3 - Data Sorted by Substance for IS(A) Analysis Method [XLS]
- B4 - Data Sorted by Substance for IS(A)-10 Analysis Method [XLS]
- B5 - Data Sorted by Substance for IS(A)-100 Analysis Method [XLS]
- B6 - Data Sorted by Substance for IS(B) Analysis Method [XLS]
- B7 - Data Sorted by Substance for IS(B)-10 Analysis Method [XLS]
- B8 - Data Sorted by Substance for IS(B)-100 Analysis Method [XLS]
- B9 - Data Sorted by Substance for Q-Score Analysis Method [XLS]
- B10 - Data Sorted by Substance for S-Score Analysis Method [XLS]
- Appendix C: In Vivo and In Vitro Comparison of Ocular Irritancy Classification
- C1 - Test Method Protocols used to Generate In Vitro Data [XLS]
- C2 - Data Sorted by Reference [XLS]
- C3 - Data Sorted by Substance for IS(A) Analysis Method [XLS]
- C4 - Data Sorted by Substance for IS(A)-10 Analysis Method [XLS]
- C5 - Data Sorted by Substance for IS(A)-100 Analysis Method [XLS]
- C6 - Data Sorted by Substance for IS(B) Analysis Method [XLS]
- C7 - Data Sorted by Substance for IS(B)-10 Analysis Method [XLS]
- C8 - Data Sorted by Substance for IS(B)-100 Analysis Method [XLS]
- C9 - Data Sorted by Substance for Q-Score Analysis Method [XLS]
- Appendix D: Performance Analysis for All Protocols [XLS]
References for the HET-CAM Test Method
|