皮肤腐蚀性

 

化学品及原料测试方法（OECD测试指南431）

 

描述

根据OECD测试指南431中EpiSkinTM和SkinEthicTM RHE体外皮肤腐蚀性测试方法，基于应用表皮模型的测试结果对化学物质进行分类标签，决定包装要求。针对OECD测试指南439方法判定为皮肤刺激性的原料，也可通过该腐蚀性测试方法补充体外皮肤腐蚀性评估数据。

 

模型 

SkinEthicTM RHE 表皮模型
EpiSkinTM 表皮模型（小孔径）

 

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腐蚀性测试评估，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）皮肤腐蚀性测试方法（下载流程图）
  • SkinEthicTM RHE 表皮模型皮肤腐蚀性测试方法（下载流程图)   

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参考文献

A way forward of alternative methods in China: Implementation of skin corrosivity potential using in vitro reconstructed human epidermis.Y. Liu, N. Li, L. Chen, L. Zhong, M. Zhou, L. Pan, D. Chen, W. Gu, Y. Li, W. Wang, Y. Guo, J. Cotovio, J. Qiu, N. Alépée, Z. Cai. Toxicology in vitro, 52: 321-331, 2018.

 

The usefulness of the validated SkinEthic™ RHE test method to identify skin corrosive UN GHS subcategories. N. Alépée , C. Robert, C. Tornier, J. Cotovio. Toxicology In Vitro, 28: 616-625, 2014.

 

Sub-categorisation of skin corrosive chemicals by the EpiSkinTM reconstructed human epidermis skin corrosion test method according to UN GHS: revision of OECD Test Guideline 431. N. Alépée, M.-H. Grandidier, J. Cotovio. Toxicology In Vitro, 28: 131-145, 2014.

 

Sub-categorisation of skin corrosive chemicals by the EpiSkinTM reconstructed human epidermis skin corrosion test method according to UN GHS: revision of OECD Test Guideline 431. N. Alépée, M.-H. Grandidier, J. Cotovio. Toxicology In Vitro, 28: 131-145, 2014.

 

Adaptation of the validated SkinEthicTM Reconstructed Human Epidermis (RHE) skin corrosion test method to 0.5 cm² tissue sample. C. Tornier, M. Roquet, A. de Brugerolle de Fraissinette. Toxicology In Vitro, 24 : 1379-1385, 2010.

 

Assessment of the human epidermis model SkinEthicTM RHE for in vitro skin corrosion testing of chemicals according to new OECD TG 431. H Kandárová, M. Liebsch, H. Spielmann, E. Genschow, E. Schmidt, D. Traue, R. Guest, A. Whittingham, N. Warren, A. O. Gamer, M. Remmele, T. Kaufmann, E. Wittmer, B de Wever, M. Rosdy. Toxicology In Vitro, 20: 547-559, 2006.

 

The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the management team. J. H. Fentem, G. E. B. Archer, M. Balls, P. A. Botham, R. D. Curren, L K. Earl, D. J. Esdaile, H.-G. Holzhütter, M Liebsch. Toxicology In Vitro, 12: 483-524, 1998.