Cater Kathleen C, Harbell John W
The Dial Corporation, Scottsdale, Arizona, USA.
Cutan Ocul Toxicol. 2008;27(2):77-85. doi: 10.1080/15569520801914381.
The bovine corneal opacity and permeability (BCOP) assay can be used to predict relative eye irritation potential of surfactant-based personal care formulations relative to a corporate benchmark. The human eye sting test is typically used to evaluate product claims of no tears/no stinging for children's bath products. A preliminary investigation was conducted to test a hypothesis that the BCOP assay could be used as a prediction model for relative ranking of human eye irritation responses under conditions of a standard human eye sting test to surfactant-based formulations. BCOP assays and human eye sting tests were conducted on 4 commercial and 1 prototype body wash (BW) developed specifically for children or as mild bath products. In the human eye sting test, 10 mul of a 10% dosing solution is instilled into one eye of each panelist (n = 20), and the contralateral eye is dosed with sterile water as a control. Bulbar conjunctival erythema responses of each eye are graded at 30 seconds by an ophthalmologist. The BCOP assay permeability values (optical density at 490 nm [OD(490)]) for the 5 BWs ranged from 0.438 to 1.252 (i.e., least to most irritating). By comparison, the number of panelists exhibiting erythema responses (mild to moderately pink) ranged from 3 of 20 panelists for the least irritating BW to 10 of 20 panelists for the most irritating BW tested. The relative ranking of eye irritation potential of the 5 BWs in the BCOP assay compares favorably with the relative ranking of the BWs in the human eye sting test. Based on these findings, the permeability endpoint of the BCOP assay, as described for surfactant-based formulations, showed promise as a prediction model for relative ranking of conjunctival erythema responses in the human eye. Consequently, screening of prototype formulations in the BCOP assay would allow for formula optimization of mild bath products prior to investment in a human eye sting test.
牛角膜混浊与通透性（BCOP）试验可用于预测基于表面活性剂的个人护理配方相对于企业基准的相对眼刺激潜力。人眼刺痛试验通常用于评估儿童沐浴产品无泪/无刺痛的产品宣称。进行了一项初步调查，以检验一个假设，即BCOP试验可作为一种预测模型，用于在标准人眼刺痛试验条件下，对基于表面活性剂的配方的人眼刺激反应进行相对排名。对4种商业产品和1种专门为儿童开发或作为温和沐浴产品的原型沐浴露（BW）进行了BCOP试验和人眼刺痛试验。在人眼刺痛试验中，将10%给药溶液的10 μl滴入每位受试者（n = 20）的一只眼睛，对侧眼睛滴入无菌水作为对照。在30秒时由眼科医生对每只眼睛的球结膜红斑反应进行分级。5种BW的BCOP试验通透性值（490 nm处的光密度[OD(490)]）范围为0.438至1.252（即从刺激性最小到最大）。相比之下，出现红斑反应（轻度至中度粉红色）的受试者数量范围为，刺激性最小的BW的20名受试者中有3名，至测试的刺激性最大的BW的20名受试者中有10名。5种BW在BCOP试验中的眼刺激潜力相对排名与在人眼刺痛试验中的相对排名良好匹配。基于这些发现，如针对基于表面活性剂的配方所述，BCOP试验的通透性终点显示出有望作为人眼中结膜红斑反应相对排名的预测模型。因此，在BCOP试验中对原型配方进行筛选将允许在投入人眼刺痛试验之前对温和沐浴产品进行配方优化。
