ABSTRACT

Eye irritation testing of ophthalmic and non-ophthalmic products forms the basis of guidelines and recommendations of worldwide regulatory agencies in the evaluation of product safety to protect and safeguard the health of humans. This public health service covers a complete range of manufactured or raw materials to which humans can be exposed in the home or workplace. These agencies make an analysis of a prod­ uct or compound proposed for marketing by establishing a safety profile after toxico­ logical evaluations have been conducted. Such evaluations are usually performed by the supplier or manufacturer of the product (or a subcontractor with expertise in this area) under specifically delineated guidelines (GLP, or good laboratory practices, is a widely accepted standard) and submitted to the respective agencies for review. There is frequently an iterative process involved beyond the initial data submission where the agency will ask for further data before re-review and approval or disapproval for human exposure (Green, Sobel, et al., 1981).