A critical review of the assessment of eye irritation potential using the Draize rabbit eye test.

Traditionally, the eye irritation potential of substances and products has been assessed using the Draize eye test. While this procedure has been criticized in terms of its scientific validity and its ethical acceptability, it remains the only official, government-recognized procedure for predicting the irritant effect of substances in the eye. The relative absence of serious human accidents testifies to the success of the predictions. With the development of alternative non-animal procedures to replace the Draize test, the data generated in the Draize procedure are also being used as a 'gold standard' against which the performance of alternative procedures is measured. The major sources of variability are small group size and inability of existing scoring systems to reflect the complexities of the total in vivo response. In addition, the use of algorithms to simplify the in vivo data (for comparison with in vitro data) also misrepresents the in vivo data. Addressing the above issues would inevitably increase the use of animals. This would go against the general public demand for a reduction in the use of animals. Therefore the issue is to decide upon a simple parameter (for comparison with in vitro data) that encompasses the complexity of the irritation response and accurately reflects irritation without requiring the use of additional test animals. Such a parameter could be the recovery time. In addition, controlled human testing to benchmark the Draize data would be invaluable. The future use of Draize data in the validation of in vitro alternatives is undisputed, but the utility of these data will only be enhanced by a proper understanding of the shortcomings of the Draize test.