FIRST PHASE INTER-LABORATORY VALIDATION OF THE IN VITRO EYE IRRITATION TESTS FOR COSMETIC INGREDIENTS: (5) EVALUATION OF SKIN2TM DERMAL MODEL ZK1100

AKIHIRO KURISHITA1,2, TOSHINORI KATO1,2, TSUTOMU FURUMOTO1,2, TOYOZO KANEKO3, KAORI INOUE1,4, YUUKO OKAMOTO1,5, HAJIME KOJIMA1,6, MINORU KATAGIRI7, HIROYUKI UEDA7, YASUO OHNO7 and AKIRA TAKANAKA8
1Japan Cosmetic Industry Assoc. (JCIA), 4th floor Hatsumei Bldg., 9-14, Tranomon, 2-chome, Minato-ku, Tokyo 105, Japan; 2Procter & Gamble Far East Inc., JHQ/TC 17, Koyo-cho Naka I-chome, Higashinada-ku, Kobe 658, Japan; 3Div. of Toxicology, Mitamura Building, 26-1 Kaitaicho, Shinjuku-ku, Tokyo 112-0012 Japan 1-18-1, Kamiyoga, Setagaya-ku, Tokyo 158, Japan; 4Shiseido Safety & Analytical Research Center, 1050 Nippa-cho, Kohoku-ku. Yokohama 223, Japan; 5Div. Fundamental Research, KOSE Corporation, 1-18-4 Azusawa, Itabushi-ku, Tokyo 174, Japan; 6Biochemical Research Institute, Nippon Menard Cosmetic Co Ltd., 4-66, Asakusa, Ohgaki-shi, Gifu 503, Japan; 7Oriental Yeast Co., Ltd., 3-6-10 Azusawa, Itabashi-ku, Tokyo 174, Japan; 8Div. of Phamacology, Mitamura Building, 26-1 Kaitaicho, Shinjuku-ku, Tokyo 112-0012 Japan 1-18-1, Kamiyoga, Setagaya-ku, Tokyo 158, Japan

Regular Article :AATEX 3(4):162-167

Abstract
A collaborative validation study with laboratories was conducted to evaluate three-dimensional cultured cell method, SKINTM Model ZK1000R (SKIN2), as an alternative to the Draize rabbit eye irritation test (Draize test) using physiological saline and 9 surfactants. MTT (3-[4,5-dimethylthiazole-2-yl]-2,5-diphenyl tetrazolium bromide)-50 values. indicating the concentration of test materials which reduce cells survive to 50% of control, were compared to the results of the Draize test. Physiological saline (S-1) and POE hydrogenated castor oil (S-2) had MTT-50 values greater than 10,000ug/ml and were classified as non-irritants, which coincided with the classication by the Draize test. Correlation coefficients for comparison of the MTT-50 values for the other eight surfactants with the maximum average Draize total score (MAS), the score at 24-hours, and the area under the Draize score-time curve (AUC) were -0.92, -0.91, and -0.91, respectively. Higher correlations with cornea and conjunctive scores were noted. Interlaboratory differences in the results were not significant. These results indicate that SKIN2 test is promising as a useful and reliable alternative method to the Draize test.

Key words: validation study, Draize eye irritation test, alternatives, surfactant, dermal model, in vitro, MTT, 3D-culture.


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