Symposium I: Mechanisms of Chemically-Induced Ocular
Injury and Recovery
(May 11-12, 2005)
Symposium II: Minimizing Pain and Distress in
Ocular Toxicity Testing
(May 13, 2005)
National Institutes of Health - Bethesda, MD
Sponsored by ICCVAM, NICEATM, the European Centre for the Validation of Alternative Methods (ECVAM)
and the European Cosmetic, Toiletry and Perfumery Association
Organized by ICCVAM, NICEATM and ECVAM
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View Presentation summarizing the Symposia
Presented by Dr. William S. Stokes, D.V.M., D.A.C.L.A.M.
Director, NICEATM
at the meeting of the Scientific Advisory Committee on Alternative Toxicological Methods -
December 12, 2005
View Detailed Symposia Goals and Objectives
View Detailed Agenda for both Symposia
(Agenda includes references and information about previous relevant symposia)
Return to Ocular Toxicity page
Symposium I - Mechanisms of Chemically-Induced Ocular Injury and Recovery
Symposium Goals: to identify research needed to address current knowledge gaps and to advance the development and
validation of ocular toxicity test methods for regulatory testing that provide for protection of human health while reducing,
refining (less pain and distress), and/or replacing the use of animals.
The participants in Symposium I made the following recommendations:
- Data collected from objective, quantitative endpoints and biomarkers should be used to assess the severity of
chemically-induced ocular injuries in animal safety studies and human accidental exposures.
- The routine collection of this data can be expected to:
- Provide insights into chemical-specific mechanisms of ocular injury and recovery
- Support the development and validation of more predictive mechanism-based in vitro test models
- Improve the accuracy and reliability of ocular hazard assessments
- Aid in identifying predictive, mechanism-based earlier humane endpoints
Abbreviated Agenda
Session 1 – Overview of Recent Initiatives and Regulatory Requirements for Ocular Toxicity Testing
Session 2 – Current Ocular Injury and Toxicity Assessments
Session 3 – Mechanisms and Biomarkers of Ocular Injury and Recovery
Panel Discussion
Session 4 – Current In Vitro Models of Ocular Injury and Recovery
Panel Discussion
Session 5 – In Vivo Quantitative Objective Endpoints to Support Development and Validation of Predictive In Vitro Models
Panel Discussion
Summary of Symposium Discussions
Symposium II - Minimizing Pain and Distress in Ocular Toxicity Testing
Symposium Goals: To review current understanding of the sources and mechanisms of pain and distress in ocular
toxicity testing; identify current best practices for preventing, recognizing and alleviating ocular
pain and distress; and to identify additional research, development, and validation studies
necessary to support scientifically valid ocular testing procedures that avoid pain and distress.
The participants in Symposium II made the following recommendations:
- Pre-treatment with topical or general anaesthesia should be used routinely to avoid pain from topical application
of test substances
- Systemic analgesics should be administered prior to test article application and continued until injuries resolve
or the study is terminated
- Ocular injuries predictive of severe or irreversible ocular damage should be used as earlier humane endpoints
- Objective, quantitative measurements should be collected during ocular studies to assist in identifying earlier,
more humane endpoints. Data from these measurements are also critical to the development and validation of more predictive
in vitro methods.
Abbreviated Agenda
Session 1 – Recognition and Sources of Pain in Ocular Injuries and Ocular Safety Testing
Panel Discussion
Session 2 – Alleviation and Avoidance of Ocular Injury and Pain
Panel Discussion
Session 3 – Biomarkers Predictive of Severe and/or Irreversible Effects that Might Serve as
Earlier Humane Endpoints for Ocular Studies
Panel Discussion
Summary of Symposium Discussions
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