Assessment of human epidermal model LabCyte EPI-MODEL for in vitro skin irritation testing according to European Centre for the Validation of Alternative Methods (ECVAM)-validated protocol
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概要
- 論文の詳細を見る
A validation study of an in vitro skin irritation testing method using a reconstructed human skin model has been conducted by the European Centre for the Validation of Alternative Methods (ECVAM), and a protocol using EpiSkin (SkinEthic, France) has been approved. The structural and performance criteria of skin models for testing are defined in the ECVAM Performance Standards announced along with the approval. We have performed several evaluations of the new reconstructed human epidermal model LabCyte EPI-MODEL, and confirmed that it is applicable to skin irritation testing as defined in the ECVAM Performance Standards. We selected 19 materials (nine irritants and ten non-irritants) available in Japan as test chemicals among the 20 reference chemicals described in the ECVAM Performance Standard. A test chemical was applied to the surface of the LabCyte EPI-MODEL for 15min, after which it was completely removed and the model then post-incubated for 42hr. Cell viability was measured by MTT assay and skin irritancy of the test chemical evaluated. In addition, interleukin-1 alpha (IL-1α) concentration in the culture supernatant after post-incubation was measured to provide a complementary evaluation of skin irritation. Evaluation of the 19 test chemicals resulted in 79% accuracy, 78% sensitivity and 80% specificity, confirming that the in vitro skin irritancy of the LabCyte EPI-MODEL correlates highly with in vivo skin irritation. These results suggest that LabCyte EPI-MODEL is applicable to the skin irritation testing protocol set out in the ECVAM Performance Standards.
- 日本トキシコロジー学会の論文
- 2009-06-01
著者
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Katoh Masakazu
Japan Tissue Engineering Co. Ltd. R&d Department
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Hata Kenichiro
Japan Tissue Engineering Co. Ltd. R&d Department
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Hamajima Fumiyasu
Japan Tissue Engineering Co. Ltd. R&d Department
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Ogasawara Takahiro
Japan Tissue Engineering Co. Ltd. R&d Department
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Katoh Masakazu
R & D Department, Japan Tissue Engineering Co., Ltd.
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Hamajima Fumiyasu
R & D Department, Japan Tissue Engineering Co., Ltd.
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Ogasawara Takahiro
R & D Department, Japan Tissue Engineering Co., Ltd.
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Hata Ken-ichiro
R & D Department, Japan Tissue Engineering Co., Ltd.
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