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2022-08-26 10:49:50

近期对眼部产品的BCOP查的比较严格的有亚马逊美国站和欧盟站点。

一五九九九五三八九四七/钟S

The BCOP (Bovine Corneal Opacity and Permeability) assay is an in vitro eye irritation test method developed by Gautheron et al. (1992), which uses living bovine corneal tissue, obtained as a by-product from abattoirs, to evaluate the potential ocular irritancy of a test article. Types of injury caused by exposure to the test article are quantitatively measured by changes in opacity and permeability to fluorescein.
牛角膜混浊和通透性试验（BCOP ）是一项体外眼刺激试验，由Gautheron et al. (1992)研究开发而来。该试验使用从屠宰场获取的新鲜牛角膜评估供试品的潜在眼刺激性。通过牛眼角膜浑浊度和对荧光素的通透性改变，定量检测供试品暴露所致的损伤类型。
The BCOP assay allows for the investigation of the mechanism of the damage caused. Corneal opacity can be caused by protein denaturation or the induction of stromal swelling, while corneal permeability reflects a loss in corneal barrier function and cell-to-cell membrane junctions of the corneal epithelium.
BCOP试验可用于研究导致损伤的机制。蛋白变性或基质肿胀可导致角膜混浊，而角膜屏障功能和角膜上皮细胞之间细胞膜的连接受损则可表现为角膜通透性改变。
An additional histological endpoint can be added to assess the corneal swelling, hydration, or morphological alterations in the cornea. This assessment evaluates the type of observed lesions and the depth of injury into the corneas.
此外，也可补充组织学终点指标，以评估角膜肿胀、脱水或形态学上的改变。组织学评估主要在于评价观察到的损伤类型以及角膜的损伤深度。

一五九九九五三八九四七/钟S
Assay Model:
Organotypic, bovine corneas (obtained as a by-product from abattoirs)
试验模型：牛眼角组织（取自屠宰场的副产品）
Endpoints:
Opacity (determined by measuring the amount of light transmitted through the cornea).
Permeability (determined by measuring the amount of fluorescein dye that penetrates through the cornea).
终点指标：
1 浊度值，通过测量角膜的透光量确定
2 通透性，通过测量渗透过角膜的荧光素染料数量确定
Each assay includes a positive and negative control.
每次试验均设置阳性对照和阴性对照。
Sensitivity
BCOP is primarily used to evaluate test materials in the moderate to extreme irritancy/corrosive range. However, exposure protocol modifications can be made to increase the sensitivity of the assay system to resolve among milder ingredients and formulations.
灵敏度
BCOP主要用于评价中重度眼刺激/腐蚀的测试物。不过，可修改暴露方案，以提高试验系统的敏感性，进而用于轻度眼刺激/腐蚀性制剂成分的评价。