Mesoporous silica (MS) particles have been explored for various healthcare applications, but universal data about their safety and/or toxicity are yet to be well-established for clinical purposes. Information about general toxicity of hollow MS (HMS) particles and about immunotoxicity of MS particles are significantly lacked. Therefore, acute toxicity and immunotoxicity of HMS particles were experimentally evaluated. A systematic and objective literature study was parallelly performed to analyze the published in vivo toxicity of MS particles. Lethal acute toxicity of MS particles is likely to arise from their physical action after intravenous and intraperitoneal administrations, and only rarely observed after subcutaneous administration. No clear relationship was identified between physicochemical properties of MS particles and lethality as well as maximum tolerated dose with some exceptions. At sub-lethal doses, MS particles tend to accumulate mainly in lung, liver, and spleen. The HMS particles showed lower inflammation-inducing ability than polyinosinic-polycytidylic acid and almost the same allergy-inducing ability as Alum. Finally, the universal lowest observed adverse effect levels were determined as 0.45, 0.81, and 4.1 mg/kg (human equivalent dose) for intravenous, intraperitoneal, and subcutaneous administration of MS particles, respectively. These results could be helpful for determining an appropriate MS particle dose in clinical study.

介孔二氧化硅 (MS) 颗粒已被探索用于各种医疗保健应用，但有关其安全性和/或毒性的通用数据尚未完全确定用于临床目的。关于空心 MS (HMS) 颗粒的一般毒性和 MS 颗粒的免疫毒性的信息非常缺乏。因此，对HMS颗粒的急性毒性和免疫毒性进行了实验评估。同时进行了系统客观的文献研究，以分析已发表的 MS 颗粒的体内毒性。MS 颗粒的致命急性毒性很可能是由于它们在静脉内和腹腔内给药后的物理作用引起的，并且在皮下给药后很少观察到。除了一些例外，在 MS 颗粒的物理化学性质和致死率以及最大耐受剂量之间没有明确的关系。在亚致死剂量下，MS 颗粒倾向于主要积聚在肺、肝和脾中。HMS颗粒显示出比聚肌苷-聚胞苷酸更低的炎症诱导能力和与明矾几乎相同的过敏诱导能力。最后，对于 MS 颗粒的静脉内、腹膜内和皮下给药，普遍观察到的最低不良反应水平分别确定为 0.45、0.81 和 4.1 mg/kg（人体当量剂量）。这些结果可能有助于在临床研究中确定合适的 MS 颗粒剂量。HMS颗粒显示出比聚肌苷-聚胞苷酸更低的炎症诱导能力和与明矾几乎相同的过敏诱导能力。最后，对于 MS 颗粒的静脉内、腹膜内和皮下给药，普遍观察到的最低不良反应水平分别确定为 0.45、0.81 和 4.1 mg/kg（人体当量剂量）。这些结果可能有助于在临床研究中确定合适的 MS 颗粒剂量。HMS颗粒显示出比聚肌苷-聚胞苷酸更低的炎症诱导能力和与明矾几乎相同的过敏诱导能力。最后，对于 MS 颗粒的静脉内、腹膜内和皮下给药，普遍观察到的最低不良反应水平分别确定为 0.45、0.81 和 4.1 mg/kg（人体当量剂量）。这些结果可能有助于在临床研究中确定合适的 MS 颗粒剂量。