皮肤刺激性

化学品及原料测试方法(OECD测试指南439

 

描述 

根据OECD测试指南439中EpiSkinTM和SkinEthicTM RHE的体外皮肤刺激性测试方法,基于应用表皮模型的测试结果对化学物质进行分类。如果被测物质的分类结果为刺激性,可根据需求进一步测试体外皮肤腐蚀性。

 

模型 

EpiSkinTM 表皮模型(小孔径)

SkinEthicTM RHE表皮模型

 

操作原则

EpiSkinTM表皮模型(小孔径)和SkinEthicTM RHE 表皮模型均可以用于体外皮肤刺激性测试评估,应遵循相应的SOP操作规范。 

 

详细测试步骤 

  • EpiSkinTM 表皮模型(小孔径)皮肤刺激性测试方法(下载流程图
  • SkinEthicTM RHE 表皮模型皮肤刺激性测试方法(下载流程图

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参考文献

In vitro skin irritation assessment becomes a reality in China using areconstructed human epidermis test method. N. Li, Y. Liu, J. Qiu, L. Zhong, N. Alépée, J. Cotovio, Z. Cai. Toxicology in Vitro, 41:159-167, 2017.

 

Use of HPLC/UPLC-spectrophotometry for detection of formazan in in vitro Reconstructed human Tissue (RhT)-based test methods employing the MTT-reduction assay to expand their applicability to strongly coloured test chemicals. N. Alépée, J. Barroso, A. De Smedt, B. De Wever, J. Hibatallah, M. Klaric, K. R. Mewes, M. Millet, U. Pfannenbecker, M. Tailhardat, M. Templier, P. McNamee. Toxicology In Vitro, 29: 741-761, 2015.

 

A catch-up validation study on reconstructed human epidermis (SkinEthicTM RHE) for full replacement of the Draize skin irritation test. N. Alépée, C. Tornier, C. Robert, C. Amsellem, M.-H. Roux, O. Doucet, J. Pachot, M. Meloni, A. de Brugerolle de Fraissinette. Toxicology In Vitro, 24: 257-266, 2010.

 

The ECVAM international validation study on in vitro tests for acute skin irritation: report on the validity of the EPISKIN and EpiDerm Assays and on the Skin Integrity Function Test. H. Spielmann, S. Hoffmann, M. Liebsch, P. Botham, J. H. Fentem, C. Eskes, R. Roguet, J. Cotovio, T. Cole, A. Worth, J. Heylings, P. Jones, C. Robles, H. Kandárová, A. Gamer, M. Remmele, R. Curren, H. Raabe, A. Cockshott, I. Gerner, V. Zuang. Alternatives To Laboratory Animals, 35: 559-601, 2007.