INTER-LABORATORY VALIDATION STUDY OF THE SKIN^2 DERMAL MODEL ZK1100 AND MTT CYTOTOXICITY ASSAY KITS

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An inter-laboratory validation study was conducted to evaluate the potential of 4 chemicals to cause irritation with utilizing the Skin^2 Dermal Model ZK1100 kit developed by Advanced Tissue Sciences, Inc. (formerly Marrow-Tech, Inc., La Jolla, California, USA). The chemicals tested were sodium dodecyl sulfate (SDS), 1-n-hexadecyl-pyridinium chloride monohydrate (CC), ethanol (EtOH), and dimethyl sulfoxide (DMSO). Eleven Japanese insititutions participated in this validation research to evaluate the usefulness of the Skin^2 Model ZK1100 kit in accordance with an identical protocol. None of the participating laboratories had previously used the Skin^2 Model ZK1100 kit. The MTT-50 value obtained in the individual institutions was 42 to 91 μg/ml for SDS, 2.7 to 8.6 μg/ml for CC, 2.0 to 9.3% for EtOH, and 11.5 to 21.9% for DMSO. Reproducibility was reasonably good as noted when one test chemical was repetitively tested by the same investigator. MTT-50 values obtained with the present method correlated with DS20 values obtained with Draize's method (r=0.9881) in one of the participant institutions. The irritation study using the Skin^2 Model ZK1100 kit was easy to perform and generated quantitative data. When the test was repeated, reproducibility was demonstrated with a variation of less than 2 6. These data suggested that this newly developed in vitro method would be useful in toxicity screening studies in terms of both time and cost, and would serve as a useful alternative to the conventional methods of the eye irritation study.
日本トキシコロジー学会の論文
1994-02-25

INTER-LABORATORY VALIDATION STUDY OF THE SKIN^2 DERMAL MODEL ZK1100 AND MTT CYTOTOXICITY ASSAY KITS

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