牛角膜浑浊和渗透性试验方法结合组织病理学对化妆品眼刺激性的预测价值

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Abstract Objective To establish a method for evaluating cosmetic eye irritation with bovine corneal opacity and permeability (BCOP) combined with corneal epithelial histological score. Methods BCOP method was used for nine commercial body wash and dye hair cosmetics eye irritation test, at the same time to make HE dyeing from corneal histology slice, the histopathological changes of the cornea and histopathological changes of epithelial score (H) were observed, on the basis of the BCOP test results, corneal epithelium histological grading and Draize test results, prediction model was established. Results The non-irritating substance was that IVIS≤3 and H=0; the slightly irritating substance was that IVIS≤6 and H≤1; and the light irritating substance was that 6<IVIS< 25, and the corneal stroma and endothelium were not abnormal. Conclusion BCOP method combined with histopathological assessment of corneal epithelial injury can improve its predictability and is suitable for the evaluation of cosmetic eye irritation.

Key words： Cosmetic products Eye irritation Bovine corneal opacity and permeability Corneal epithelium Histopathology

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	XIE Zhen CHEN Shuhuai LIU Lu HE Licheng ZHU Shemin KUANG Rong

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XIE Zhen CHEN Shuhuai LIU Lu HE Licheng ZHU Shemin KUANG Rong. Predictive value of bovine corneal opacification and permeability test in combination with histopathology in eye irritation of cosmetic products[J]. 中国医药导报, 2021, 18(4): 14-17.

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http://www.yiyaodaobao.com.cn/EN/ OR http://www.yiyaodaobao.com.cn/EN/Y2021/V18/I4/14

[1] 张劲松，桑晶，匡荣，等.BioOcularTM角膜上皮模型ET50法在化妆品体外眼刺激评价中的应用[J].中国现代应用药学，2017，34（6）：846-848.
[2] 桑晶，张劲松，徐玲燕，等.三维重组眼角膜上皮模型法与兔眼刺激法对洗发水眼刺激性的比较与评价[J].中国现代应用药学，2017，34（5）：662-665.
[3] 程树军，秦瑶，柯逸晖，等.替代方法在化妆品检测中的应用分析[J].中国比较医学杂志，2017，27（10）：101-106.
[4] 罗飞亚，王刚力，邢书霞，等.化妆品安全性评价替代试验的研究进展及思考[J].中国医药生物技术，2016，11（5）：470-476.
[5] 李小林，王伟，奚杰，等.欧盟化妆品实验动物禁令对上海化妆品出口企业影响的调查[J].检验检疫学刊，2017， 27（2）：69-72.
[6] 国家食品药品监督管理总局.化妆品安全技术规范[S].2015年版.2015.
[7] 谢珍，刘璐，瞿霖吉，等.牛角膜混浊和渗透性试验方法与家兔法评价染发类化妆品眼刺激性的比较研究[J].中国现代应用药学，2017，34（7）：1025-1028.
[8] OECD. OECD guideline for testing of chemicals No.437：Bovine Corneal Opacity and Permeability Test Method for Identifying i） Chemicals Inducing Serious Eye Damage and ii） Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage [S]. Paris：OECD，2017.
[9] Andreda WM，da Ailva ACG，Valadares MC. Corneal histomorphometric analysis：The depth of damage induced in the bovine cornea correlates with the severity of the ocular toxicity [J]. Toxicol In Vitro，2019，61：104593.
[10] Lotz C，Kiesewetter L，Schmid FF，et al. Replacing the Draize eye test：Impedance spectroscopy as a 3R method to discriminate between all GHS categories for eye irritation [J]. Sci Rep，2018，8（1）：15049.
[11] Oliveira GA，Ducas Rdo N，Teixeira GC，et al. Short Time Exposure（STE）test in conjunction with Bovine Corneal Opacity and Permeability （BCOP） assay including hist-opathology to evaluate correspondence with the Globally Harmonized System（GHS）eye irritation classification of textile dyes [J]. Toxicol In Vitro，2015，29（6）：1283-1288.
[12] Furukawa M，Sakakibara T，Itoh K，et al. Suggestion of the updated IVIS cut-off values for identifying nonocular irritants in the bovine corneal opacity and permeability（BCOP） assay [J]. Toxicol In Vitro，2017，45（pt 1）：19-24.
[13] Kolle SN，Sauer UG，Moreno MC，et al. Eye irritation testing of nanomaterials using the EpiOcularTM eye irritation test and the bovine corneal opacity and permeability assay [J]. Part Fiber Toxicol，2016，13：18.
[14] 陈彧，喻欢，程树军，等.结合组织学评分的牛角膜浑浊和渗透性方法研究[J].日用化学工业，2016，46（2）：106-110.
[15] OECD. OECD guideline for testing of chemicals No.437：Bovine Corneal Opacity and Permeability Test Method for Identifying i）Chemicals Inducing Serious Eye Damage and ii）Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage[S]. Paris：OECD，2013.
[16] Bukowiecki A，Hos D，Cursiefen C，et al. Wound-Healing Studies in Cornea and Skin：Parallels，Differences and Opportunities [J]. Int J Mol Sci，2017，18（6）：1257.
[17] Dua HS，Gomes JA，Singh A，et al. Corneal epithelial wound healing [J]. Br J Ophthalmol，1994，78（5）：401-408.
[18] Furukawa M，Sakakibara T，Itoh K，et al. Histopathological evaluation of the ocular-irritation potential of shampoos，make-up removers and cleansing foams in the bovine corneal opacity and permeability assay [J]. J Toxicol Pathol，2015，28（4）：243-248.
[19] Wilson SL，Ahearne M，Hopkinson A. An overview of current techniques for ocular toxicity testing [J]. Toxicology，2015，327：32-46.
[20] Cater KC，Harbell JW. Prediction of eye irritation potential of liquid and granular laundry detergent formulas using the bovine corneal opacity and permeability（BCOP）assay [J]. Cutan Ocul Toxicol，2013，32（3）：210-221.
[21] Verstraelen S，Maglennon G，Hollanders K，et al. CON4EI：Bovine Corneal Opacity and Permeability（BCOP）Test for Hazard Identification and Labelling of Eye Irritating Chemicals [J]. Toxicol In Vitro，2017，44：122-133.
[22] Furukawa M，Sakakibara T，Itoh K，et al. Suggestion of the updated IVIS cut-off values for identifying nonocular irritants in the bovine corneal opacity and permeability(BCOP) assay [J]. Toxicol In Vitro，2017，45（pt 1）：19-24.
[23] 何立成，朱社敏，谢珍，等.鸡胚绒毛膜尿囊膜血管试验法用于评价化妆品眼刺激性的可行性研究[J].中国现代应用药学，2017，34（8）：1158-1162.