Non-animal photosafety assessment approaches for cosmetics based on the photochemical and photobiochemical properties

详细信息    查看全文

• 作者：Satomi Onoue ; Gen Suzuki ; Masashi Kato ; Morihiko Hirota ; Hayato Nishida ; Masato Kitagaki ; Hirokazu Kouzuki ; Shizuo Yamada
• 关键词：3T3 NRU PT ; 3T3 neutral red uptake phototoxicity testing ; ANOVA ; one-way analysis of variance ; CMC ; critical micelle concentration ; DMSO ; dimethyl sulfoxide ; ECVAM ; European Centre for the Validation of Alternative Methods ; ICH ; International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ; IFRA ; International Fragrance Association ; JaCVAM ; Japanese Center for the Validation of Alternative Methods ; JPMA ; Japan Pharmaceutical Manufacturers A
• 刊名：Toxicology in Vitro
• 出版年：December, 2013
• 年：2013
• 卷：27
• 期：8
• 页码：2316-2324
• 全文大小：1347 K

文摘

The main purpose of the present study was to establish a non-animal photosafety assessment approach for cosmetics using in vitro photochemical and photobiochemical screening systems. Fifty-one cosmetics, pharmaceutics and other chemicals were selected as model chemicals on the basis of animal and/or clinical photosafety information. The model chemicals were assessed in terms of photochemical properties by UV/VIS spectral analysis, reactive oxygen species (ROS) assay and 3T3 neutral red uptake phototoxicity testing (3T3 NRU PT). Most phototoxins exhibited potent UV/VIS absorption with molar extinction coefficients of over 1000 M^鈭?cm^鈭?, although false-negative prediction occurred for 2 cosmetic phototoxins owing to weak UV/VIS absorption. Among all the cosmetic ingredients, ca. 42% of tested chemicals were non-testable in the ROS assay because of low water solubility; thereby, micellar ROS (mROS) assay using a solubilizing surfactant was employed for follow-up screening. Upon combination use of ROS and mROS assays, the individual specificity was 88.2%, and the positive and negative predictivities were estimated to be 94.4% and 100%, respectively. In the 3T3 NRU PT, 3 cosmetics and 4 drugs were incorrectly predicted not to be phototoxic, although some of them were typical photoallergens. Thus, these in vitro screening systems individually provide false predictions; however, a systematic tiered approach using these assays could provide reliable photosafety assessment without any false-negatives. The combined use of in vitro assays might enable simple and fast non-animal photosafety evaluation of cosmetic ingredients.