【摘要】 目的分别使用3D皮肤模型和皮肤致敏性替代法及传统动物实验研究纳米铜的皮肤刺激性和致敏性。方法采用Epi Kutis 3D皮肤模型研究纳米铜的皮肤刺激性。皮肤致敏性替代法采用小鼠局部淋巴结试验:LLNA:Brd UELISA方法和LLNA:DA方法研究纳米铜的致敏性;同时根据GB/T 21604-2008和GB/T 21608-208化学品皮肤刺激性和致敏试验方法研究纳米铜应用液的皮肤刺激性和致敏性。结果 3D皮肤模型皮肤刺激性试验结果表明1%纳米铜应用液(69 mg/L)和0.25%纳米铜应用液(17.2 mg/L)ET50值均大于24 h,两者均无刺激性。纳米铜应用液(6.9 g/L)的ET50值为14.86 h(ET50值为12~24 h之间),刺激性属于非常温和。LLNA:Brd U试验结果表明:纳米铜组小鼠耳肿胀、耳重、淋巴结重量和Brd U标记指数与对照组比较差异均无统计学意义(P>0.05),表明纳米铜应用液刺激性为阴性。SI值为1.3<1.6,为致敏性阴性。LLNA:DA试验结果表明:纳米铜组小鼠耳肿胀、耳重、淋巴结重量和ATP发光值与对照组比较差异均无统计学意义(P>0.05),表明纳米铜应用液刺激性为阴性。SI值为1.3<1.8,致敏性阴性。传统家兔皮肤刺激性和致敏性试验结果表明,6.9 g/L纳米铜应用液无刺激性。结论 3D皮肤模型皮肤刺激性试验和皮肤致敏性替代法与传统皮肤刺激性和致敏试验结果一致,可对本试验中纳米材料刺激性和致敏性做出较好评价。更多还原

【Abstract】 Objective To study the skin irritation and sensitization of copper nanoparticles liquid applied to textiles by a 3 D reconstructed human skin model,alternative method of skin sensitization test and traditional animal tests. Methods An Epi Kutis 3 D reconstructed human skin model was used to study the skin irritation of copper nanoparticles liquid. LLNA: DA and LLNA: Brd U-ELISA were used to study the skin sensitization of copper nanoparticles liquid. According to "Test method of skin irritation for chemicals( GB/T21604-2008) "and"Test method of skin sensitization for chemicals( GB/T 21608-2008) ",the skin irritation and sensitization of copper nanoparticles liquid were researched. Results The 3 D skin model irritation test showed that the ET50 values of 69 mg/L and 17. 2 mg/L of copper nanoparticles liquid were both greater than 24 h and could be classified as"non-irritant". The ET50 value of copper nanoparticles liquid( 6. 9 g/L) was 14. 86 h and could be classified as "mild". LLNA: Brd U assay result had shown that the parameters of mice in the copper nanoparticles liquid group compared with these in the control group had no statistical difference( P > 0. 05). The irritation of copper nanoparticles liquid was negative. The SI value was 1. 3 < 1. 6 and sensitization of copper nanoparticles was negative too. LLNA: DA assay result had shown that the parameters in the copper nanoparticles liquid group compared with these in the control group had no statistical difference( P > 0. 05) either. The irritation of copper nanoparticles liquid was negative. The SI value was 1. 3 < 1. 8 and sensitization of copper nanoparticles was negative too. Traditional chemical skin irritation and sensitization test result showed that the copper nanoparticles liquid( 6. 9 g/L) was"non-irritant"and"non-sensitized"Conclusion The result showed in the new method 3 D reconstructed human skin model and "Test method of skin irritation for chemicals( GB/T 21604-2008) "are consistent. The copper nanoparticles liquid( 6. 9 g/L)was "non-irritant". The result showed in alternative method of skin sensitization test and "Test method of skin sensitization for chemicals( GB/T 21608-2008) "are consistent.更多还原