VALIDATION OF HUMAN SKIN MODELS FOR SKIN CORROSIVITY TESTS IN JAPAN.
This study by scientists at NIHS, Nihon Nohyaku Co., Ltd., Nippon Soda Co., Ltd., The Inst. Of Environmental Toxicology, Nippon Menard Cosmetic Co., Ltd., Sumitomo Chemical Co., Ltd., Kyoto University, and Tokyo University demonstrated that MatTek’s EpiDerm in vitro human skin tissue equivalent can be used to reliably determine the dermal corrosivity potential of chemicals. As a validation trial of alternatives for skin corrosivity testing in Japan, scientists at NIHS, Nihon Nohyaku Co., Ltd., Nippon Soda Co., Ltd., The Inst. Of Environmental Toxicology, Nippon Menard Cosmetic Co., Ltd., Sumitomo Chemical Co., Ltd., Kyoto University, and Tokyo University performed a validation study of EPI-200 (EpiDerm™), a 3-dimensional cultured epidermal model and Vitrolife-Skin™, a 3-dimensional cultured skin model. In this validation study, 6 laboratories took part excluding the kit suppliers (Kurabo Industries Ltd. and GUNZE Co., Ltd.). Participants performed the pre-test and main trial and obtained cut-off percentage cell viability values (viability after 3 minutes or 1 hour exposure) over a three month period from February to April 2004. Twelve chemicals were selected and coded, then 10 chemicals were supplied to each laboratory. As a result, most chemicals did not show any great differences in scores on tests repeated at each laboratory. Inter-laboratory variation was significant in Sulfuric acid alone, and the feasibility of using EPI-200 and Vitrolife-Skin was suggested through the experiment. Furthermore, we compared the validation testing data and in vivo database in ECVAM. Comparing corrosivity data, the consistency rate of tests using EpiDerm EPI-200 was 81.7%. The chemicals showing false positives were 5% Potassium hydroxide and Lactic acid, but Sulfuric acid alone showed a false negative response. On comparison of the consistency rate of tests using Vitrolife-Skin showed 83.3%, the chemicals showing false positives were 5% Potassium hydroxide and Lactic acid, whereas none of the chemical showed a false negative response. These data showed that the reliability of these two models was similar to the results obtained on the ECVAM validation.
3-dimensional cultured skin models, Corrosivity Tests, ECVAM, EPI-200, EpiDerm, OECD guidelines, Transcutaneous electrical resistance (TER) test
4-Amino-1,2,4-triazole, Chromium trioxide, Isopropanol (2-propanol), L-Lactic acid, Octanoic (Caprylic) acid, Phenol, Phosphoric acid, Potassium hydroxide, Sodium hydroxide, Sodium perborate, Sulfuric acid, Tetrachloroethylene
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