In Vitro Assessment of Skin Irritation Potential of Surfactant-based Formulations by Using a 3-D Skin Reconstructed Tissue Model and Cytokine Response

Russel M. Walters, Lisa Gandolfi, M. Catherine Mack, Michael Fevola, Katharine Martin, Mathew T. Hamilton, Allison Hilberer, Nicole Barnes, Nathan Wilt, Jennifer R. Nash, Hans A. Raabe and Gertrude-Emilia Costin Johnson & Johnson

Summary — The personal care industry is focused on developing safe, more efficacious, and increasingly milder products, that are routinely undergoing preclinical and clinical testing before becoming available for consumer use on skin. In vitro systems based on skin reconstructed equivalents are now established for the preclinical assessment of product irritation potential and as alternative testing methods to the classic Draize rabbit skin irritation test. We have used the 3-D EpiDerm™ model system to evaluate tissue viability and primary cytokine interleukin-1α release as a way to evaluate the potential dermal irritation of 224 nonionic, amphoteric and/or anionic surfactant-containing formulations, or individual raw materials. As part of our testing programme, two representative benchmark materials with known clinical skin irritation potential were qualified through repeated testing, for use as references for the skin irritation evaluation of formulations containing new surfactant ingredients. We have established a correlation between the in vitro screening approach and clinical testing, and are continually expanding our database to enhance this correlation. This testing programme integrates the efforts of global manufacturers of personal care products that focus on the development of increasingly milder formulations to be applied to the skin, without the use of animal testing.


EPI-200, IL-1a, Skin irritation, rinse-off products, skin-care cleansing formulations, baby wash, baby shampoo, adult facial cleanser, adult body wash, adult shampoo

Materials Tested

alpha olefin sulphonate, sodium lauroyl isethionate, sodium cocoyl glycinate, coco-betaine, sodium cocoyl glutamate, sodium cocoyl isethionate, capryloyl methyl glucamide, caproyl methyl glucamide, lauroyl methyl glucamide, cocamidopropyl betaine, sodium laureth-13 carboxylate, cocoyl methyl glucamide, coco-glucoside, polyglycerol-10 laurate, SH potato starch dodecenylsuccinate, lauroyl methyl glucamide (C16-C18), polyglycerol, polyethylene oxide, SLS, glycinate, ethanol

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