Stern M, Klausner M, Alvarado R, Renskers K, Dickens M
Avon Products, Inc., Avon Place, Suffern, NY 10901, USA.
Toxicol In Vitro. 1998 Aug;12(4):455-61. doi: 10.1016/s0887-2333(98)00017-4.
Cosmetic ingredients were tested to determine the ability of the EpiOcular(TM) tissue model to predict eye irritation potential. In vitro results were compared with historical Draize eye irritation records. Forty-three samples, consisting of 40 cosmetic raw ingredients of different type and physical form (i.e. liquids, powders, gels) were evaluated. Using the MTT cytotoxicity assay, an ET(50) value (effective time of exposure to reduce tissue viability to 50%) was determined for each sample. ET(50) values were categorized into four irritation groups: (a) non-irritating/minimal; (b) mild; (c) moderate; or (d) severe/extreme. Comparison of in vitro EpiOcular(TM) and in vivo Draize classifications showed that 63% (27 of 43 samples) were classified identically. Assay performance improved to 95% (41 of 43 samples) with the addition of samples overpredicted by a single irritation class. This evaluative exercise represents a conservative safety assessment. There were no underpredictions of eye irritation for any material in this study. Based on these results, use of the EpiOcular(TM) tissue model shows promise as an in vitro assay to assess the ocular irritation potential of cosmetic ingredients.
对化妆品成分进行了测试，以确定EpiOcular™组织模型预测眼刺激性的能力。将体外实验结果与既往的Draize眼刺激记录进行比较。评估了43个样品，包括40种不同类型和物理形态（即液体、粉末、凝胶）的化妆品原料。使用MTT细胞毒性试验，确定每个样品的ET(50)值（使组织活力降低至50%的有效暴露时间）。ET(50)值被分为四个刺激等级：(a)无刺激/极小刺激；(b)轻度刺激；(c)中度刺激；或(d)重度/极重度刺激。体外EpiOcular™和体内Draize分类的比较表明，63%（43个样品中的27个）分类相同。通过加入被高估一个刺激等级的样品，检测性能提高到95%（43个样品中的41个）。这项评估工作代表了一种保守的安全性评估。本研究中没有任何材料的眼刺激被低估。基于这些结果，使用EpiOcular™组织模型作为评估化妆品成分眼刺激性的体外试验显示出前景。
