Acceptance and Use of In Vitro and Ex Vivo Eye Irritation Test Methods
ฝัง
- เผยแพร่เมื่อ 22 ก.ย. 2024
- Hans Raabe, MS, Institute for In Vitro Sciences
Human relevant approaches to assess eye irritation: Overview and comparative analysis of test methods
For over 30 years, efforts have been made to implement non-animal test methods to replace the rabbit Draize eye irritation test, and although numerous methods have been used for specific applications, no non-animal based test methods have been accepted for full global replacement of the Draize test. Recently, changes in the approaches to developing and evaluating non-animal test systems are paving the path towards human relevant ocular safety assessments. This presentation will give an overview of human corneal physiology, and the nature of key eye irritation events; it will introduce the Depth of Injury concept, and focus upon the key mechanistic features of available non-animal test methods to help guide the appropriate selection of test methods to optimize ocular safety assessments.
João Barroso, PhD, European Commission, Joint Research Centre
Alternative approaches for the assessment of serious eye damage/eye irritation
The assessment of serious eye damage/eye irritation hazards is a basic information requirement in international regulations for the safety assessment of chemicals, pesticides and medicines. Some regulations require this information to be generated without the use of animals. Evaluations of the rabbit Draize eye test have shed light on its lack of reproducibility and human relevance. Therefore, the validation and regulatory acceptance of in vitro test methods for serious eye damage/eye irritation has received a lot of attention with several methods being adopted by the OECD. Defined approaches combining in vitro methods are also under consideration for international acceptance. These developments led to the revision of chapter 3.3 on serious eye damage/eye irritation of the UN GHS. This presentation will give an overview of non-animal approaches accepted or under consideration by the OECD and of the revisions introduced in chapter 3.3 of UN GHS.
This webinar is the ninth in a series hosted by the Physicians Committee for Responsible Medicine, US Environmental Protection Agency, and PETA Science Consortium International on the use of non-animal methods in risk assessment.
