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J. Soc. Cosmet. Chem., 24, 135-146 (February 2, 1973) Animal, Human, and Microbiological Safety Testing of Cosmetic Products M. J. THOMAS, Ph.D., and P. A. MAJORS, M.S.* Presented October 27, 1971, before the California Chapter Synopsis-The three principal areas of TESTING pertinent to COSMETICS are discussed. These include SAFETY determination in ANIMALS, safety and efficacy studies in HUMANS, and MICROBIOLOGICAL STUDIES for safety and product stability. Prod- ucts must be shown safe to animals prior to use on humans. Most animal studies include, for the most part, acute and subacute studies. The former are done in accordance with the Federal Hazardous Substances Act (FHSA) requirements. There are a number of patch tests applicable to human safety testing of products. The modified Draize technique appears to be the preferred procedure. It serves as a good predictor of sensitizing potential and supplies information on the primary irritant charac- teristics and cmnulative primary irritant properties of the test materials. A test program is also presented for determination of adequacy of PRESERVATIVES in new and cur- rent cosmetic products. INTRODUCTION The increasing emphasis placed by our Government on the safety of foods, drugs, and similar products has been expanded into the area of cosmetic prod- ucts in the last few years. Those in the independent research and testing lab- oratory fields are very much aware of this change because they have been an integral part of the developing program and have seen the various regulations evolve. Just as the regulatory requirements for safety in food additives and drug products became more definitive as time passed, so will the regulatory requirements for cosmetic products be more specific and more pronounced as time goes on. The objective here is to summarize the present trends and methods used in testing for the safety and efficacy of cosmetic products. Recent action of the *Hill Top Research, Inc., Miamiville, Ohio 45147. 135