This study aimed to assess the cytotoxic effect of low molecular weight components (LMWC) and conventional silicone oils (SOs) 1000 cSt with different degree of purification (raw, intermediate, and purified) using in vitro cytotoxicity tests. Direct contact cytotoxicity tests were performed in BALB 3T3 and human retinal pigment epithelial cells (ARPE-19) using quantitative and qualitative evaluation according to the ISO 10993-5 (2009) standards. Conventional SOs 1000 cSt in form of raw, intermediate (intermediate product obtained during distillation process), and purified SO (final product after distillation) and a concentrate of LMWC (including siloxane chains with molecular weight up to 1557 g/mol) were directly applied to 100% of cell layer area for 24 h. Cell viability was quantified using 3-(4,5-dimethylthiazole-2-yl)-2,5-28 diphenyltetrazolium bromide (MTT) and neutral red uptake assays in ARPE-19 and BALB3T3, respectively. All tested samples, including the concentrate of LMWC, resulted to be not cytotoxic according to ISO 10993-5 in both qualitative and quantitative evaluations. However, the cellular viability was significantly higher in the intermediate and purified SO compared with the raw SO in ARPE-19 cells. No reduction in cell viability was detected by LMWC. The absence of cytotoxicity was observed for all tested samples in both BALB3T3 and ARPE-19 after 24 h of application. A direct cytotoxic effect is not likely to be involved in the potential complications related to SO and LMWC. Long-term potential adverse effects of SO could be related to the raw material and to different concentrations of LMWC.

中文翻译：

---

硅油作为眼内医疗设备的安全性：一项体外细胞毒性研究。

这项研究旨在通过体外细胞毒性试验评估具有不同纯化度（原始，中间和纯化）的低分子量成分（LMWC）和常规硅油（SOs）1000 cSt的细胞毒性作用。根据ISO 10993-5（2009）标准，使用定量和定性评估方法对BALB 3T3和人视网膜色素上皮细胞（ARPE-19）进行直接接触细胞毒性测试。直接应用粗制，中间体（蒸馏过程中获得的中间产物），纯化的SO（蒸馏后的最终产物）和LMWC浓缩物（包括分子量最高为1557 g / mol的硅氧烷链）形式的常规SOs 1000 cSt至细胞层面积的100％，持续24小时。使用3-（4,5-二甲基噻唑-2-基）-2定量细胞活力 在ARPE-19和BALB3T3中分别进行了5-28溴化二苯基四唑鎓（MTT）和中性红吸收测定。根据ISO 10993-5的定性和定量评估，所有测试的样品（包括LMWC的浓缩物）均无细胞毒性。但是，与ARPE-19细胞中的原始SO相比，中间和纯化SO中的细胞活力明显更高。LMWC未检测到细胞活力的降低。施用24小时后，在BALB3T3和ARPE-19中，所有测试样品均未观察到细胞毒性。与SO和LMWC相关的潜在并发症可能不涉及直接的细胞毒性作用。SO的长期潜在不利影响可能与原料和不同浓度的LMWC有关。