Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay

Prediction of ocular irritancy of prototype shampoo formulations by the isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay
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DOI:
10.1016/s0887-2333(00)00060-6
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发表时间:
2001-04-01
影响因子:
3.2
通讯作者:
Raabe, H
Raabe, H
中科院分区:
医学3区
文献类型:
--
作者:
Cooper, KJ;Earl, LK;Raabe, H

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评价了离体兔眼(IRE)试验和牛角膜混浊和渗透性(BCOP)试验预测一系列洗发剂配方(其中一些含有已知为眼刺激物的新型非表面活性剂成分)的眼刺激潜力的能力。将角膜肿胀和组织学检查的额外终点纳入标准BCOP方案。几种制剂的历史Draize数据可用作参考。当暴露时间为10分钟和60分钟(分别用于未稀释和10%稀释的洗发剂)时,标准BCOP测定(无组织学)无法区分低刺激性和高刺激性洗发剂,并且体外评分将大多数制剂归类为轻度。将组织学终点纳入BCOP方案允许区分不同刺激性的制剂,应纳入以增强标准BCOP方案。然而,角膜肿胀值与测试的洗发水的刺激性潜力无关。包括角膜肿胀和组织病理学评分终点的IRE产生的刺激性分类与体内数据相当一致,并区分了高刺激性和低刺激性洗发水。(C)2001爱思唯尔科技有限公司版权所有。
The isolated rabbit eye (IRE) test and bovine corneal opacity and permeability (BCOP) assay were evaluated for their ability to predict the eye irritation potential of a range of hair shampoo formulations, some containing a novel non-surfactant ingredient known to be an ocular irritant. The additional endpoints of corneal swelling and histological examination were incorporated into the standard BCOP protocol. Historic Draize data were available for several of the formulations and served as a reference. The standard BCOP assay (without histology) failed to distinguish between shampoos of low and high irritant potential, when exposure times of 10 and 60 min were employed (for undiluted and 10% dilution of the shampoos, respectively) and the in vitro score classified the majority of formulations as mild. The incorporation of the histological endpoint to the BCOP protocol allowed discrimination between formulations of differing irritancy, and should be included to augment the standard BCOP protocol. Corneal swelling values did not, however, correlate with the irritant potential of the shampoos tested. The IRE which includes the endpoints of corneal swelling and histopathological scoring produced classifications of irritancy that were fairly consistent with in vivo data and distinguished between the high and low irritant potential shampoos. (C) 2001 Elsevier Science Ltd. All rights reserved.