358 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS CONCLUSION Potential problems of predictive testing of the safety of a cosmetic product have been pointed out. Particularly troublesome are the follow- ing: The selection of the test(s) and of the test population inadvertent experimental errors problems of interpretation, which are related pri- marily to the absence of well-documented scientific information. It is pointed out that in-use testing under clinical supervision is highly desir- able and should be seriously considered as an adjunct to the battery of known skin predictive procedures. Two unusual examples from the authors' files illustrate these problems and support these inferences. In the authors' experience, the results of a sound predictive testing program are useful for anticipating the product's safety in the market place. (Received December 21, 1970) REFERENCES (1) Kligman, A.M., The identification of contact allergens by human assay. I. A critique of standard methods, J. Invest. Dermatol., 47, 369-74 (1966). (2) Brunner, M. J., Pitfalls and problcms in predictive testing, J. Soc. Cosmet. Chem., 18, 323-31 (1967). (3) Idson, B., Topical toxicity and testing, ]. Pharm. Sci., 57, 1-11 (1968). (4) Kligman, A.M., The identification of contact allergens by human assay. 111. The maxi- mization test: a procedure for screening and rating contact sensitizers, J. Invest. Dermatol., 47, 393-409 (1966). (5) Wooding, W. M., and Opdyke, D. L., A statistical approach to the cvaluation of cutaneous responses to irritants, J. Soc. Cosmet. Chem., 18, 809-29 (1967). (6) Barron, B. A., Variations on a theinc--The evaluation of ncccssary and unnecessary risks, Toxicol. Ap•t•l. Pharmacol., Suppl. 3, 72-5 (1969). (7) Opdykc, D. L., and Burnett, C. M., Practical problems in tire evaluation of the safety of cosmetics, Proc. Sci. Yecl. Toilet Goods Ass., 44, 3-4 (1965). (8) Food and Drug Administration, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, Association of Food and Drug Officials of the U.S., Texas S,tate Depart- ment of Health, Austin, Tex., 1959. (9) Wolven, A., and Levcnstein, I., Techniques for evaluating derreal irritation, ]. Soc. Cosmet. Chem., 18, 199-203 (1967). (10) Marzulli, F. N., et al., Delayed contact hypersensitivity studies in man and animals, Proc. Joint Co•f. Cosmet. $ci., Washington, D.C., 107-22 (1968). (11) Magnusson, B., and Klignnan, A.M., The identification of contact allcrgcns by animal assay. The guinea pig maximization test, J. Invest. Dermatol., 52, 268-76 (1969). (12) Maibach, H. I., and Epstein, W. L., Predictive patch testing for allergic sensitization in man, Toxicol. Appl. Pharmacol., Suppl. 2, 39-43 (1965). (13) Rubenkoenig, H. L., and Quisno, R. A., Use of the patch test in estimating hazards to the skin, Proc. Sci. Sect. Toilet Goods Ass., 28, 6-8 (1957). (14) Magnusson, B., and Hersle, K., Patch test methods. I. A comparative study of six dif- ferent typcs of patch tests, Acta Dermato-Venereol., 45, 123-8 (1965).
PROBLEMS OF PREDICTIVE TESTING 359 (15) I,anman, B. M., et al., The role of human patch testing in a product development pro- gram, Proc. Joint Conf. Cosmet. Sci., Washington, D. G., 135-45 (1968). (16) Kligmarl, A.M., and Wooding, W. M., A method for the measurement and evaluation of irritants on human skin, J. Invest. Derrnatol., 49• 78-94 (1967). (17) Wolcott, G. L., A plea for in-use testing of cosmetics, Drug Cosmet. Ind., 93, 155-265 (1963). (18) Rieger, M. M., and Battista, G. W., Some experiments in the sa[ety testing o• cosmetics, J. Soc. Cosmet. Chem., 15• 161-72 (1964). (19) Kligman, A.M., Evaluation of cosmetics for irritancy, Toxicol. Appl. Pharmacol., Suppl. 3, 30-44 (1969). (20) Justice, J. D., et al., The correlation between animal and human tests in assessing product mildness, Proc. Sci. Sect. Toilet Goods ASS., •5• ]2 (1961). (21) Kligman, A.M., The identification of contact allergens by human assay. II. Factors influencing the induction and measurement of allergic contact dermatitis, J. Invest. Dermatol., 47• 375-92 (1966). (22) Forsbcck, M., et al., The [requency of allergic diseases among relatives to patients with allergic eczematous contact dermatitis, Acta Dermato-Venereol., 46• 149-52 (1966). (23) Baer, R. L., et al., Changing patterns of sensitivity to common contact allergens, Arch. Dermatol., 89, 3-8 (1964). (24) Agrup, G., Sensitization induced by patch testing, Brit. J. Dermatol., 80, 631-4 (1968). (25) Magnusson, B., and Hersle, K., Patch test methods. II. Regional variations of patch test responses, Acta Dermato-Venereol., 45, 257-61 (1965). (26) Magnusson, B., and Hersle, K., Patch test methods. III. Influence of adhesive tape on test response, Ibid., 46, 275-8 (1966). (27) Lowhey, E. D., Attenuation of contact sensitization in man, J. Invest. Dermatol., 50, 244-9 (1968). (28) Rebelh), D. J. A., and Suskind, R. R., The effect of common contactants on cutaneous re- activity to sensitizers, Ibid., 41, 67-80 (1963). (29) Sipos, K., Chemical hypersensitivity and dermatological diseases, Dermatologica, 135, 421-32 (1967). (30) Hjorth, N., Seasonal variations in contact dermatitis, Acta Dermato-Venereol., 47• 409-18 (1967). (31) BeltIcy, F. R., and Grice, K. A., The effect of sweating on patch test reactions to soap, Brit..J. Dermatol., 78, 636-9 (1966).
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