280 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS NINTH ANNUAL SEMINAR SOCIETY OF COSMETIC CHEMISTS September 19-20, 1962 Hotel Biltmore, New York City "Skin Metabolism" "Prediction of Stability in Cosmetic Formulations" "Anti-Dandruff" ridmission covering entire seminar $30.00 for members $35.00 for non-members

INTERPRETATION OF EYE IRRITATION TESTS By JoN H. KAY, and JOSEPH C. CAI•ND•.•, Presented March !3, !962, Chicago ONE OF THE PROBLEMS which frequently confront those individuals in the cosmetic industry who are entrusted with product safety responsi- bilities to one degree or another is the interpretation of the results of ophthalmic irritancy tests conducted in laboratory animals. As toxicolo- gists, we are often called upon to aid such individuals in coming to decisions affecting their products, i.e., to help them draw what may be critical con- clusions from the results of eye irritation studies, particularly in the case of new products still in early developmental stages. In many instances, further development of a prospective product which may have excellent sales potential is arrested temporarily, or even permanently, purely on the basis of conclusions drawn from the results of eye irritation studies. In fact, some cosmetic firms use ophthalmic irritancy routinely as the principal evaluative criterion for checking all new products early in their develop- mental stages. Such tests are, in reality, "pass-fail" type examinations which often determine product "death" or "survival." Obviously then, careful evaluation and interpretation of animal eye irritation data can be a consideration of paramount importance and it is the purpose of this paper to discuss some basic guide lines which may be of value in a construc- tive approach to the problem. Although a number of procedures exist today for evaluating eye irritation in animals, most of the methodological differences encountered are simply variations on a fundamental theme. The animal still most often em- ployed is the albino rabbit and the most frequently adopted basic protocol and scoring system are those originally developed and published by Draize, Woodard and Calvery (1). Rather than attempt to discuss all the modifi- cations and elaborations which have been made upon this basic test, attention will be confined, for the most part, to evaluation of eye irritation studies carried out using it alone. In essence, the well-recognized "Draize technique" makes provision for scoring eye irritation quantitatively at the end of each of six specified time intervals following ocular instillation of the test material. The time * Industrial Bio-Test Laboratories, Inc., Northbrook, Ill. 281