348 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS (39) Piattelli, M., et al., The structure of melanins anti melanogenesis. II. Sepiomelanin and synthetic pigments, Tetrahedron, 18, 941-9 (1962). (40) Piattelli, M., et al., The structure of melanins and melanogenesis. III. The structure of sepiomelanin, Ibid., 19, 2061-72 (1963). (41) Bollert, V., and Eckert, L., Quantitative verfolgung des Blondie•vorgangs von Human- haar, J. Soc. Cosmet. Chem., 19, 275-88 (1968). (42) Flesch, P., The red pigmentary system and its relation to black melanogenesis, Ibid., 21, 77-83 (1970).

J. Soc. Cosmet. Chem., 22, 349-359 (May 27, 1971) Some Problems of Predictive Testing G. •q. BATTISTA, Ph.D., and M. M. RIEGER, Ph.D.* Presented December 1-2, 1970, New York City Synopsis--TEST PROCEDURES available for the SAFETY EVALUATION of toiletties and COSMETICS are reviewed. Some obvious deficiencies of these tests, possible pitfalls, ques- tionable parameters, and the organization of an evaluation program are discussed. The in- terpretation of preclinical animal and of clinical human safety data and the importance of in-use tests in determining whether or not a product is safe are also considered. A few clini- cal experiences are presented to illustrate the discussion. INTRODUCTION Product safety is one of the primary concerns of all drug and cos- merit manufacturers. In the case of drugs, the term safety becomes rela- tive, and any side effects can be weighed against the benefits derived. The safety of drugs is one of degree, and consumer inconvenience or even risk can be tolerated depending on the product and what it will do for the patient. Drugs can be and often are an essential part of one's health and, in severe circumstances, can be life saving. On the other hand, cosmetics are not life saving, but contribute to general well-being by virtue of beautification, decoration, and camouflage. •qithin this framework, the manufacturer of cosmetics and toiletries must assume great responsibility for consumer safety, whether it be for reasons of morality or just plain good business sense. Consumer tolerance to irritation or inconvenience resulting from the use of cosmetics is very low there is no room for side * Warner Lambert Research Institute, 170 Tabor Rd., Morris Plains, N.J. 07950. 349