The goal of the Interagency Regulatory Alternatives Group workshop was to set a course for the scientific approval and acceptance of non-whole animal alternatives to the Draize eye test. Through a retrospective review of existing in vitro and in vivo data by expert working groups, the endeavor examined the current status of practical application of in vitro alternatives used to predict eye irritation. Over 74 data sets from 59 laboratories were reviewed for approximately 26 different test methods. It was concluded that (1) data are insufficient to support the total replacement of in vivo ocular irritancy testing with in vitro methods; (2) alternative methods to the in vivo standard (Draize) are currently being used extensively by industry as screens in the risk assessment process for product development; and (3) based upon current practices for ocular irritancy testing, it appears that some models exist that may have the potential to reduce the need for new animal testing, provided they are validated and conducted under well-defined conditions. Several recommendations are proffered to facilitate scientific review of in vitro and in vivo data sets in parallel.