FIRST PHASE INTER-LABORATORY VALIDATION OF THE IN VITRO EYE IRRITATION TESTS FOR COSMETIC INGREDIENTS: (1) OVERVIEW, ORGANIZATION AND RESULTS OF THE VALIDATION STUDY
YASUO OHNO1, TOYOZO KANEKO2, TOSHIAKI KOBAYASHI3,4, TOHRY INOUE5, YUKIO KUROIWA6, TAKEMI YOSHIDA6, JUNKO MOMMA2, MAKOTO HAYASHI7, JUNICHI AKIYAMA3,8, TAKAMASA ATSUMI3,9, KATSUYOSHI CHIBA3,10, TAKASHI ENDO3,11, AKIO FUJII3,12, HIROSHI KAKISHIMA3,11, HAJIME KIOJIMA3,14, YUKIMITSU MASAMOTO3,15, MITSUTERU MASUDA3,16, KYOJI MATSUKAWA3,17, KENJI OHKOSHI3,18, JOSHIN OKADA3,19, KAZUTAMI SAKAMOTO3,20, KATSUHIRO TAKANO3, TOSHIRO SUZUKI21, AKIRA TANAKA1
1Div. of Phamacology, Biological Safety Resource Center (BSRC), Mitamura Building, 26-1 Kaitaicho, Shinjuku-ku, Tokyo 112-0012 Japan 1-18-1, Kamiyoga, Setagaya-ku, Tokyo 158, Japan;
2Div. of Toxicology, BSRC, NlHS. 1-18-1, Kamiyoga, Setagaya-ku, Tokyo 158, Japan;
3Japan Cosmt. Industry Assoc. (JCIA), Hatsumei Bldg., 9-14, Toranomon, 2-chome, Minato-ku, Tokyo 105, Japan;
4Shiseido Safety & Analytical Research Center, 1050 Nippa-cho, Kohoku-ku. Yokohama 223, Japan;
5Div. of Pathology, School of Med., Yokohama City University, 3-9 Fukuuru, Kanazawa-ku, Yokohama 236, Japan;
6Div. of Toxicology, School of Pharm. Sci., Showa Univ., 1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142, Japan;
7Div. of Genetics and Mutugenicity, BSRC, NIHS, 1-18-1, Kamiyoga, Setagaya-ku, Tokyo 158, Japan;
8Kaminomoto Co., Ltd., 3-3-35, Kumochibashidori, Chuo-ku, Kobe 658, Japan;
9Shiga Central Research Laboratory, NOEVIR Co. Ltd., 112-1, Okada-cho, Yokaichi-shi, Shiga 527, Japan;
10Safety Research Center, Yakult Central Institute for Microbiological Research, 1796 Yuo, Kunitachi-shi, Tokyo 186, Japan;
11Procter & Gamble Far East Inc., JHQ/TC 17, Koyo-cho Naka I-chome, Higashinada-ku, Kobe 658, Japan;
12POLA Corporation, 560 Kashio-cho, Totsuka-ku, Yokohama 244, Japan;
13Kanebo Cosmetic Laboratory, 3-28, 5-chome, Kotobuki-cho, Odawara-shi, Kanagawa 256, Japan;
14Biochemical Research Institute, Nippon Menard Cosmetic Co Ltd., 4-66, Asakusa, Ohgaki-shi, Gifu 503, Japan;
15SUNSTAR Inc., 3-1 Asahi-machi, Takatsuki-shi, Osaka 569, Japan;
16Human Safety Evaluation Center, Lion Corporation, 100 Tajima, Odawara-shi, Kanagawa 256, Japan;
17OPPEN Cosmetic Co. Ltd., 2-28-2 Shinaike, Setsu-shi, Osaka 569, Japan;
18Div. Fundamental Research, KOSE Corporation, 1-18-4 Azusawa, Itabushi-ku, Tokyo 174, Japan;
19KAO Corp. Tochigi Biological Sciences, 2606 Akabane, Ichikai, Haga, Tochigi 321-34, Japan;
20Applied Research Laboratories, Central Research Laboratories, Ajinomoto Co. Inc., 1-1 Suzuki-cho, Kawasuki-ku, Kawasaki 210, Japan;
21Japan Seigiken Research Center Co. Ltd., 95-10 Aoimachi, Hamamutsu-shi, Shizuoka 433, Japan.
Regular Article :AATEX 3(4):123-136
Preliminary validation studies on twelve methods proposed as alternatives to the Draize eye irritation test using nine coded surfactants and physiological saline solution were conducted by twenty laboratories including a National Health Institute, universities, kit suppliers, and cosmetic companies. The results indicated that:
intra-and interlaboratory variations were generally small excepting the study of hemolysis by Tween 20;
rank order of the cytotoxicity potentials of Triton X-100 by cultured cell methods with serum differed greatly from those without serum;
correlation coefficients between the results of in vitro method and in vivo Draize test are higher than 0.8 for HET-CAM-trypan blue staining method and cultured cell methods with serum. Rank order correlation coefficients between them were higher than 0.9;
correlation coefficients among cultured cell methods using serum were also high (r=0.92-O.99).
These preliminary results suggest that several of the in vitro methods evaluated in this report may be useful for the prediction of eye irritancy potential of cosmetic ingredients. However, further validation studies using a wider range of chemicals are necessary.
Key words: validation study, Draize eye irritation test, alternatives, surfactant, in vitro.