FUNDAMENTAL AND APPLIED TOXICOLOGY 26, 2 0- 3 1 ( 1995) A Collaborative Evaluation of Seven Alternatives to the Draize Eye Irritation Test Using Pharmaceutical Intermediates

Much of the data which have been generated on in vitro al-ternatives to the Draize eye irritation test have dealt with com-pounds within a specific chemical class or product category. However, in the pharmaceutical industry, it is often necessary to evaluate materials which are not related in structure or proper-ties. It was thus decided to evaluate a diverse series of chemicals in seven in vitro methods for estimating ocular irritation. Thirty-seven test materials were chosen to represent a broad range of pH, solubility, and in vivo irritation potential. Assays were cho-sen to include as many different types of end points as practical. The group of assays was composed of TOPKAT (assessing structure-activity relationships), bovine corneal opacity-perme-ability (BCO-P; corneal opacity/toxicity), Eytex (protein coagu-lation), neutral red uptake (cytotoxicity), MTT in living dermal equivalent (cytotoxicity), Microtox (cytotoxicity in bacteria)