什么是BCOP?

化妝品BCOP測(cè)試報(bào)告/牛角膜混濁和通透性試驗(yàn)

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.

牛角膜混濁和通透性試驗(yàn)（BCOP ）是一項(xiàng)體外眼刺激試驗(yàn)，由Gautheron et al. (1992)研究開(kāi)發(fā)而來(lái)。該試驗(yàn)使用從屠宰場(chǎng)獲取的新鮮牛角膜評(píng)估供試品的潛在眼刺激性。通過(guò)牛眼角膜渾濁度和對(duì)熒光素的通透性改變，定量檢測(cè)供試品暴露所致的損傷類(lèi)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試驗(yàn)可用于研究導(dǎo)致?lián)p傷的機(jī)制。蛋白變性或基質(zhì)腫脹可導(dǎo)致角膜混濁，而角膜屏障功能和角膜上皮細(xì)胞之間細(xì)胞膜的連接受損則可表現(xiàn)為角膜通透性改變。

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，也可補(bǔ)充組織學(xué)終點(diǎn)指標(biāo)，以評(píng)估角膜腫脹、脫水或形態(tài)學(xué)上的改變。組織學(xué)評(píng)估主要在于評(píng)價(jià)觀察到的損傷類(lèi)型以及角膜的損傷深度。

網(wǎng)絡(luò)圖片（侵刪）

Assay Model:
Organotypic, bovine corneas (obtained as a by-product from abattoirs)

試驗(yàn)?zāi)Ｐ停号Ｑ劢墙M織（取自屠宰場(chǎng)的副產(chǎn)品）

Endpoints:

1. Opacity (determined by measuring the amount of light transmitted through the cornea).

2. Permeability (determined by measuring the amount of fluorescein dye that penetrates through the cornea).

終點(diǎn)指標(biāo)：

1 濁度值，通過(guò)測(cè)量角膜的透光量確定

2 通透性，通過(guò)測(cè)量滲透過(guò)角膜的熒光素染料數(shù)量確定

Each assay includes a positive and negative control.

每次試驗(yàn)均設(shè)置陽(yáng)性對(duì)照和陰性對(duì)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.

靈敏度

BCOP主要用于評(píng)價(jià)中重度眼刺激/腐蝕的測(cè)試物。不過(guò)，可修改暴露方案，以提高試驗(yàn)系統(tǒng)的敏感性，進(jìn)而用于輕度眼刺激/腐蝕性制劑成分的評(píng)價(jià)。

Test Material Compatibility
The assay is compatible with both water soluble and insoluble formulations. Both solid and liquid test materials can be tested. Since test materials are topically applied, the test system is suitable for creams, pastes, highly viscous materials, and powders.

測(cè)試物的兼容性

本試驗(yàn)可用于水溶性制劑，也可用于不可溶制劑；可測(cè)試固體測(cè)試物，也可測(cè)試液體測(cè)試物。由于測(cè)試物是局部給藥，因此本試驗(yàn)系統(tǒng)也適用于乳劑、糊劑、高粘性物質(zhì)和粉末。

Alternate Endpoints
BCOP’s multiple endpoints allow the investigations of mechanism of action. An additional histological endpoint can be added to assess the types of observed lesions and the depth and degree of injury. Based upon the work of Maurer and Jester (2002), the depth and degree of injury may be used to predict the severity and outcome of the corneal injury.
Test article concentrations and exposure times may be adjusted as necessary to accommodate specific physical characteristics or client needs.

備選終點(diǎn)

BCOP有多個(gè)終點(diǎn)指標(biāo)，可進(jìn)行機(jī)制研究。此外，可補(bǔ)充組織學(xué)終點(diǎn)指標(biāo)，以評(píng)價(jià)觀察到的損傷類(lèi)型和深度?；贛aurer and Jester (2002)的研究工作，損傷的深度和程度可用于預(yù)測(cè)嚴(yán)重程度和角膜損傷的結(jié)局。

必要時(shí)，可調(diào)整供試品濃度和暴露時(shí)間，使之適應(yīng)于特定的物理性質(zhì)或客戶(hù)需求。

Validation

• In the US and in Europe, the BCOP assay has been approved for identification of corrosive substances and those chemicals not requiring classification according to UN GHS.

• OECD Test Guideline was adopted (TG437) in 2009 and revised in 2013.

• The US EPA accepts the BCOP assay as part of a tiered strategy for the labeling of cleaning products with anti-microbial claims.

有效性

在US和歐洲，BCOP已獲批用于鑒別腐蝕性物質(zhì)和鑒別按UN GHS無(wú)需分類(lèi)的化學(xué)物

OECD指導(dǎo)原則 (TG437)已于2009年被采納，并在2013年接受了修訂

US EPA 接受采用BCOP試驗(yàn)作為給清潔用品貼簽抗菌聲稱(chēng)的分級(jí)策略之一。

HISTOLOGY

組織學(xué)

The results of a histological evaluation may be used in several ways depending on the study goals. It may be used to confirm the level of corneal irritation predicted by the opacity and permeability values. In other cases, it is helpful to understand the types of lesions and the depth of injury that a material might induce in the cornea.

根據(jù)研究目的，可能會(huì)采取多種方式運(yùn)用組織學(xué)評(píng)價(jià)結(jié)果。組織學(xué)結(jié)果可用于確認(rèn)濁度值和通透率預(yù)測(cè)得到的角膜刺激性級(jí)別。另外，其還可用于闡釋測(cè)試物導(dǎo)致角膜損傷的類(lèi)型和深度。

補(bǔ)充：

BCOP試驗(yàn)過(guò)程

簡(jiǎn)圖如下，具體參見(jiàn)SN/T 4153-2015 化學(xué)品 牛角膜混濁和通透性試驗(yàn)?和?OECD437

Costin, Gertrude-Emilia et al, PROTOCOL REFINEMENT OF THE BOVINE CORNEAL AND OPACITY PERMEABILITY (BCOP) TEST FOR EYE IRRITATION

局限性

BCOP方法的局限性主要表現(xiàn)在沒(méi)有考慮受試物對(duì)虹膜和結(jié)膜的刺激作用，某些物質(zhì)可能對(duì)結(jié)膜有損傷，但對(duì)于角膜的作用不明顯，如果只采用BCOP方法可能只反應(yīng)了化合物的角膜損傷作用而忽視對(duì)結(jié)膜的可能作用。

費(fèi)用是多少？

4K-6K（具體根據(jù)產(chǎn)品判斷詳情詢(xún)）

周期有多長(zhǎng)？

5-7個(gè)工作日(可加急)