166 JOURNAL OF COSMETIC SCIENCE Interestingly, a shorter duration test, such as the five-day test presented in Table III, may be adequate to provide a quick indication of mildness differences to aid in decisions during product formulation. Although the five-day test did not yield significant dif- ferences for all endpoints, the results demonstrated directional differences. Most of these experiments used both visual and instrumental scoring methods. This provided an opportunity to compare the ability to detect differences when visual scoring was used versus instrumental scoring. In all cases, visual scoring was qualitatively similar to instrumental scoring, indicating that instrumental scoring may not be necessary to provide an indication of the relative mildness differences between products. This would be particularly useful for quick screening studies, where a complete understanding of mildness and irritating effects is not necessary. CONCLUSIONS ß A modified FCAT has been developed that can consistently detect differences in mildness for baby wipe products under hydrated skin conditions such as those found in the diaper area. The test should be of nine days' duration, and use 60-80 female panelists. Washing cycles in the modified FCAT should be conducted four times daily for six to eight consecutive days, and twice on the final day. The washing cycles should be of 15-second duration except for the final washing cycle on each day, which should be 40 seconds. Hydration can be achieved with nightly patches consisting of the J&J bandage with gauze, reinforcing tape, and 10 ml of distilled water. No conditioning or pretreatment period is necessary. Four endpoints should be evaluated: TEWL, redness by chromameter, and erytherna and dryness by visual scoring on seven-point scales. ß This method has applicability for wipes intended for other uses where mildness and irritation are critical considerations, such as wipes intended for cosmetic removal. ß Subjective measurements provide adequate endpoints in the absence of instrumental measurements. Significant differences among visual scores were very consistent with those observed with the instrumental scores. ß An abbreviated test design of five days' duration using visual scoring alone would be a cost-effective approach toward providing an indication of mildness differences to aid in formulation decisions. This abbreviated test can be followed by the more extensive study design given above for a complete understanding of mildness differences and for product claim support. ACKNOWLEDGMENTS The author is grateful to Ms. Sandy Meyer and Ms. Debbie Gilpin for their excellent technical support, to Sue Baldwin, PhD, for her scientific input into this program, to Celeste Kuta, PhD, for her technical input and review of the manuscript, and to Terresa L. Nusair, PhD, of Risk Assessment and Toxicology Services, Inc. (Cincinnati, Ohio) for the preparation of this manuscript. REFERENCES (1) D.J. Kooyman and F. H. Snyder, Tests for mildness of soap, Arch. Dermato/., 46, 846-855 (1942).
MODIFIED FCAT 167 (2) M. Hannuksela and H. Salo, The repeated open application test (ROAT), Contact Dermatitis, 14, 221-227 (1986). (3) D.D. Stube, S.W. Koontz, R. I. Murahata, and R. F. Theiler, The flex wash test: A method for evaluating the mildness of personal washing products, J. Sac. Cosmet. Chem., 40, 297-306 (1989). (4) M. F. Lukacovic, F. E. Dunlap, D. E. Michaels, M. O. Visscher, and D. D. Watson, Forearm wash test to evaluate the clinical mildness of cleansing products, J. Sac. Cosmet. Chem., 39, 355-366 (1988). (5) K.D. Ertel, B. H. Keswick, and P. B. Bryant, A forearm controlled application technique for esti- mating the relative mildness of personal cleansing products, J. Soc. Cosmet. Chem., 46, 67-76 (1995). (6) L. Phillips, M. Steinberg, H. I. Maibach, and W. A. Akers, A comparison of rabbit and human skin response to certain irritants, Toxicol. AppL Pharmacol., 21, 369-382 (1972). (7) J. Stotts, "Planning, Conduct and Interpretation: Human Predictive Sensitization Patch Tests," in Current Concepts in Cutaneous Toxicity, V. A. Drill and P. Lazar, Eds. (Academic Press, New York, 1980), pp. 41-53. (8) J. Pinnagoda, R. A. Tupker, T. Agner, and J. Serup, Guidelines for transepidermal water loss (TEWL) measurements: A report from the standardization group of the European Society of Contact Dermatitis, Contact Dermatitis, 22, 164-178 (1990). (9) S. W. Babulak, L. A. Rhein, D. D. Scala, F. A. Simion, and G. L. Grove, Quantitations of erythema in a soap chamber test using the Minolta Chroma (Reflectance) Meter: Comparisons of instrumental results with visual assessments, J. Sac. Cosmet. Chem., 37, 475-479 (1986).
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