Dataset for Hollow-fiber membrane technology: Characterization and proposed use as a potential mimic of skin vascularization towards the development of a novel skin absorption in vitro model

Historically, animal testing has been used to support risk assessment for a variety of toxicological endpoints related to cosmetic ingredients, including the local lymph node assay (LLNA) to assess the sensitization potential and potency of a chemical. However, in recent years, there has been a continuous drive to reduce the level of animal testing undertaken to support risk assessments for new cosmetic products, and a move towards a mechanistic understanding of human exposure. Consequently, the development of mechanistic/biologically relevant in vitro, in chemico or in silico models for predicting the sensitising potential and/or potency of new chemicals is necessary to generate data leading to increased confidence in predictions of in vivo scenarios. The chemical and biological events driving the induction of human skin sensitisation are now well understood and companies such as Unilever use this information in non-animal models to test the safety of new compounds. Discs of ex vivo skin (from cosmetic surgery procedures) are mounted in diffusion cells and the permeation of a test item through the skin is monitored over time. While this has proved to be an adequate model, it does not truly represent living skin. At present, little is known regarding chemical clearance via dermal capillaries, and this is a gap in our mechanistic understanding of the bioavailability of a topically applied chemical in the elicitation of skin sensitisation. The proposed capillary bed bioreactor (CBB) better replicates the in vivo environment of the skin and its blood supply by providing a bed of pseudovascularisation in the form of hollow fibre membranes. Therefore it should more accurately predict permeation of chemicals through the skin, and provide data that more closely resembles that of the in vivo scenario. The new bioreactor will be more physiologically accurate than the current model and can therefore potentially refine inputs to our mechanistic models for skin sensitisation, to give us more accurate predictions of adverse outcomes. This in turn will give greater confidence in our ability to risk assess new ingredients in the future without the requirement for animal testing.

在历史上，动物实验已被广泛应用于评估化妆品成分相关毒理学终点风险，包括局部淋巴结反应试验（LLNA），以评估化学物质的致敏潜力和效力。然而，近年来，持续推动减少为支持新化妆品产品风险评估所进行的动物实验水平，并转向对人类暴露机制的深入理解。因此，开发用于预测新化学物质致敏潜力和/或效力的机制/生物相关体外、体外化学或计算机模拟模型，以生成有助于提高体内场景预测信心的数据，变得尤为必要。目前，人类皮肤致敏诱导的化学和生物事件已被充分理解，如联合利华（Unilever）等公司即利用这些信息在非动物模型中测试新化合物的安全性。通过将来自美容手术的外植皮肤（皮肤切片）安装在扩散细胞中，并监测测试物品随时间通过皮肤的渗透情况。尽管这一模型已被证明是充分的，但它并不能真实地代表活体皮肤。目前，关于通过真皮毛细血管进行化学清除的了解甚少，这是我们对于局部外用化学物质在皮肤致敏诱发过程中的生物利用度机制理解的不足之处。所提出的毛细血管床生物反应器（CBB）通过提供由中空纤维膜构成的假血管床，更好地复制了皮肤及其血液供应的体内环境。因此，它应能更准确地预测化学物质通过皮肤的渗透，并提供更接近体内场景的数据。新的生物反应器将比当前模型更具生理准确性，从而有可能完善我们关于皮肤致敏的机制模型输入，以提供对不良结果的更精确预测。这反过来将增强我们对未来在无需动物实验的情况下进行新成分风险评估能力的信心。