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日用化学工业（中英文）

日用化学工业 ›› 2022, Vol. 52 ›› Issue (5): 529-533.doi: 10.3969/j.issn.1001-1803.2022.05.010

• 开发与应用 • 上一篇    下一篇

基于BioOcullar®模型的清洁类化妆品眼刺激性评价方法的建立

何立成1,2,孙叶丹1,2,朱社敏1,2,匡荣1,2,*()   

  1. 1.浙江省食品药品检验研究院 国家药品监督管理局化妆品动物替代试验技术重点实验室,浙江 杭州 310052
    2.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室,浙江 杭州 310052
  • 收稿日期:2021-07-30 修回日期:2022-04-29 出版日期:2022-05-22 发布日期:2022-05-24
  • 通讯作者: 匡荣
  • 基金资助:
    浙江省药品监督管理局系统科技计划项目(2021024)

Establishment of an evaluation method for eye irritation of cleansers based on BioOcullar® model

He Licheng1,2,Sun Yedan1,2,Zhu Shemin1,2,Kuang Rong1,2,*()   

  1. 1. NMPA Key Laboratory for Animal Alternative Testing Technology of Cosmetics, Zhejiang Institute for Food and Drug, Hangzhou, Zhejiang 310052, China
    2. Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Zhejiang Institute for Food and Drug, Hangzhou, Zhejiang 310052, China
  • Received:2021-07-30 Revised:2022-04-29 Online:2022-05-22 Published:2022-05-24
  • Contact: Rong Kuang

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摘要：

旨在建立基于重建人角膜样上皮模型BioOcullar®的清洁类化妆品眼刺激性评价方法,其原理是在模型表面涂抹受试物,暴露一定时间后根据角膜细胞的存活率来评价受试物眼刺激性程度。用3批已知刺激性（家兔法）的清洁类化妆品对该方法的相关条件进行探索,选择合适的暴露时间和后孵育时间,结果表明暴露60 min无后孵育时间最为合适。另取12批已知刺激性（家兔法）的清洁类化妆品对该方法进行验证并确定判定标准,根据三次评价结果确定判定标准为：无刺激性：存活率≥60%;轻刺激性：15%≤存活率<60%;刺激性：存活率<15%。最后用该方法对12批未知刺激性的清洁类化妆品进行预测,并与家兔法结果进行比较,结果显示体内外一致率为91.7%（11/12）。结果表明本研究建立的评价方法能较好地区分清洁类化妆品的眼刺激性。

关键词: 清洁类化妆品, 眼刺激性, BioOcullar®

Abstract:

Cleansers are essential daily basic cosmetics, and these products contain a high level of surfactants, which have a certain degree of eye irritation. When evaluating the eye irritation of cosmetics using the Draize test, such samples can cause hyperemia and edema of conjunctiva and changes of cornea opacity of rabbits. In order to reduce the harm to rabbits, an in vitro evaluation method was established. BioOcullar® is the first commercially available reconstructed human cornea-like epithelium model developed by a Chinese company. This model has been identified as a useful tool for the testing of irritancy. The test protocol has also been developed for chemicals. However, this protocol is not suitable for cosmetic formulations, therefore in this study a method for evaluating the eye irritation of cleansers was established based on BioOcullar®. The chemicals under test were applied to three tissues, and the tissue viability was measured after exposure and a post-treatment incubation period. Firstly, the exposure time and post-incubation time should be optimized according to the barrier function of the tissue. Secondly, the acceptance criteria should also be considered. Three batches of cleansers with known irritation （Draize test） were used to explore the relevant conditions of the method and to select the appropriate exposure time and post-treatment incubation period. The results showed that, 60 min of exposure was the most suitable, and the presence of post-treatment incubation period could reduce the sensitivity of the method. Another 12 batches of cleansers with known irritation （Draize test） were used to validate the method and determine the criteria. According to the evaluation results for three times, the acceptance criteria were: no irritation: viability≥60%; mild irritation: 15%≤viability<60%; irritation: viability<15%. Finally, the method was used to predict 12 batches of cleansers with unknown irritation and compared with the results of the Draize test with an in vitro/in vivo agreement rate of 91.7% （11/12）. The results indicate that the evaluation method established in this study can differentiate the eye irritation of cleansers.

Key words: cleanser, eye irritation, BioOcullar®

中图分类号: 

  • TQ658