Ohuchi J, Kasai Y, Sakamoto K, Ohnuma M, Kitamura M, Kawasaki Y, Kakishima H, Suzuki K, Kuwahara H, Imanishi Y, Tatsumi H, Kotani M, Inoue K, Okumura H, Arashima M, Kurishita A, Kinoshita S, Tani N, Kojima H, Nakamura T, Suzuki K, Ishibashi T, Hori H, Takahashi H, Nishikawa T, Kitano Y, Ohno Y
Japan Cosmetic Industry Association, Hatsumei Bldg., 9-14, Toranomon, Minato-ku, Tokyo 105Japan; Biological Science Laboratories, Kao Corporation, 2606, Akabane, Ichikai-machi, Haga, Tochigi 321-34Japan.
Toxicol In Vitro. 1999 Feb;13(1):153-62. doi: 10.1016/s0887-2333(98)00069-1.
MATREX(TM) is a test system for evaluating eye irritation potential, using the living dermal model (LDM). The LDM consists of normal human dermal fibroblasts in a contracted collagen lattice, which eventually forms a three-dimensional structure. This system has several advantages. It can be applied to insoluble substances and does not require sterile conditions for operation. In the present study, MATREX was introduced as an alternative to the Draize eye irritation test (Draize test) for cosmetics ingredients. MATREX was evaluated through a three-phase series interlaboratory validation as part of a joint project of the National Institute of Health Sciences (NIHS) and Japan Cosmetic Industry Association (JCIA). Toxicity for LDM was mainly evaluated by cytotoxicity, the indicator was EC(50) (concentration that inhibits the viability of the cell to 50% of control) value. Additionally, MATREX score indicating the grade of cytotoxicity was also introduced in the third phase of the validation study. Both test procedures were controlled under the same standard operating procedure (SOP), at all the participating laboratories. A total of 39 test substances both water-soluble and -insoluble were examined. LDM was applicable to almost all substances that could be evaluated by the Draize test. Furthermore interlaboratory variance was relatively low. The correlation coefficient between the EC(50) value and the maximal average Draize total score (MAS) was -0.672. The MATREX score was closely related to the EC(50) value. Moreover, the MATREX scoring method showed a similar prediction ability for eye irritation potential to the EC(50) method. Thus, the MATREX scoring method, a simplified EC(50) method, appears to be a viable alternative to the current EC(50) measurement method. The present results demonstrate the possibility that the MATREX system would form part of a prediction system of Draize test results.
MATREX™是一种利用活体真皮模型（LDM）评估眼睛刺激潜能的测试系统。LDM由收缩胶原晶格中的正常人真皮成纤维细胞组成，最终形成三维结构。该系统有几个优点。它可应用于不溶性物质，且操作不需要无菌条件。在本研究中，MATREX被引入作为化妆品成分的兔眼刺激试验（Draize试验）的替代方法。作为国立卫生科学研究所（NIHS）和日本化妆品工业协会（JCIA）联合项目的一部分，MATREX通过三阶段系列实验室间验证进行了评估。对LDM的毒性主要通过细胞毒性进行评估，指标是EC(50)（将细胞活力抑制至对照的50%的浓度）值。此外，在验证研究的第三阶段还引入了表示细胞毒性等级的MATREX评分。在所有参与实验室中，两种测试程序均按照相同的标准操作规程（SOP）进行控制。共检测了39种水溶性和不溶性测试物质。LDM适用于几乎所有可通过Draize试验评估的物质。此外，实验室间差异相对较小。EC(50)值与最大平均Draize总分（MAS）之间的相关系数为-0.672。MATREX评分与EC(50)值密切相关。此外，MATREX评分方法对眼睛刺激潜能的预测能力与EC(50)方法相似。因此，MATREX评分方法，一种简化的EC(50)方法，似乎是当前EC(50)测量方法的可行替代方法。目前的结果表明MATREX系统有可能成为Draize试验结果预测系统的一部分。
