ORIGINAL ARTICLE
The Japanese Ring Study of a Human Cell Line Activation Test (h-CLAT) for Predicting Skin Sensitization Potential (7th Report): Evaluation of Volatile, Poorly Soluble Fragrance Materials

Sakiko Sono1, Makoto Mizuno2, Nanae Kosaka3, Kenji Okamoto4,Yoshinao Kato5, Hiroyuki Inaba6, Tsuneaki Nakamura6, Masataka Kishi5, Hirofumi Kuwahara4, Hitoshi Sakaguchi3, Yuko Okamoto2, Takao Ashikaga1 and Yasuo Ohno7

1Shiseido Co., Ltd., Kanagawa, Japan; 2KOSÉ Corporation, Tokyo, Japan; 3Kao Corporation, Tochigi, Japan; 4Kanebo Cosmetics Inc., Kanagawa, Japan; 5Nippon Menard Cosmetic Co., Ltd., Aichi, Japan; 6LION Corporation, Kanagawa, Japan; 7National Institute of Health Sciences, Tokyo, Japan

AATEX 15(2):89-96, 2010

A ring study was conducted to examine whether the human Cell Line Activation Test (h-CLAT) can predict the skin sensitization potential of fragrance materials with low solubility and high volatility. Seven fragrance materials which had previously been evaluated for skin sensitization potential in vivo (local lymph node assay; LLNA) were selected. In addition, to investigate the influence of volatility or solubility of test materials, we performed the assay with or without sealing of the plate or supersonic ultrasonic wave treatment of the sample solution. All experiments were performed independently in two laboratories.
The reproducibility between the two laboratories was 100%. The accuracy with respect to LLNA was 86%: diethyl phthalate gave a false positive in the tests of both laboratories. Sealing the plate had little effect on the CV75 (75% cell viability) or CD86/CD54 RFI (relative fluorescence intensity of CD86/54 expression) values. Ultrasonic wave treatment of the sample solution altered the turbidity and CV75 values in some cases, but did not affect the CD86/CD54 RFI values. Our results indicate that h-CLAT is useful for evaluation of the skin sensitization potential of fragrance materials.

key words: skin sensitization, alternative test, fragrance, h-CLAT

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(AATEX: Altern. Animal Test. EXperiment.: Alternatives to Animal Testing and EXperimentation)