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IN VITRO ASSESSMENT OF SKIN IRRITATION POTENTIAL OF SURFACTANT BASED FORMULATIONS USING 3-D SKIN RECONSTRUCTED TISSUES AND CYTOKINE EXPRESSION ANALYSIS.

Gandolfi1, L., Tierney1, N., Johnson1, D., Walters1, R., Fevola1, M., Gunn1, E., Martin1, K., Kong2, A., Hilberer2, A., Barnes2, N., Wilt2, N., Nash2, J.R., Inglis2, H., Raabe2, H., Costin2, G-E. 1Johnson & Johnson, Skillman, NJ, United States 2Institute for In Vitro Sciences, Inc., Gaithersburg, MD, United States.
Abstract

A goal of personal care products manufacturers is to develop increasingly milder formulations. To this end, reproducible  in vitro systems can accurately assess the irritation potential of the products, thus avoiding the use of animals for  testing. The three-dimensional EpiDermTM model (MatTek Corp.) provides a testing platform for Johnson & Johnson’s  skin irritation assessment program targeting raw ingredients and final formulations. The testing program we have  developed evaluated the potential dermal irritation of over 150 amphoteric and/or anionic surfactant-containing  candidate formulations or individual raw ingredients. The formulations were diluted to 10% in water and were  applied onto the surface of the 3-D tissues for 1 h, followed by 24 h post-exposure analysis for cytokine expression.  The potential dermal irritation of the candidates was evaluated by MTT viability and IL-1α release. Another goal of  the program was to qualify two representative benchmark materials with known skin irritation potential for use as  references for the skin irritation evaluation of formulations with new surfactant ingredients. We have developed a  database and established a range of irritation responses of the benchmarks using the IL-1α endpoint. Comparison  of the potential dermal irritation of new formulations to existing mild formulations guides formulation development  for new mild cleansing products. Most recently, we have demonstrated the reliability of the test system for the  assessment of irritation potential of final formulations. We are currently expanding our database and work towards  establishing a correlation between the in vitro pre-screening approach and clinical testing. This testing platform  integrates the efforts made to meet the mildness testing needs of global manufacturers of personal care products  that focus on developing increasingly milder lines of formulations to be applied to the skin.

Keywords

Amphoteric surfactant formulations, Anionic surfactant formulations, Baby wash, Dermal irritation, EPI-200-HCF, Exaggerated patch clinical testing, Final formulations, IL-1α, Mild cleansing products, Mild skin cleansing, Rinse-off product, Skin barrier disruption, Transepidermal water loss (TEWL)

Materials Tested

Alkyl sulfate anionic surfactant, Ammonium lauryl sulfate, Baby wash formulation, Cocamidopropyl betaine, Cocoglucoside, Creamy bodywash, Decylflucoside, High foam bodywash, Men’s bodywash, Sodium alpha olefin sulfonate, Sodium cocoyl isethionate, Sodium lauryl sulfate, Sodium tridecyl sulfate

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