摘要: |
采用标准化的眼刺激性测试替代方法牛角膜浑浊和渗透性实验(bovine corneal opacit y and
permeability, BCOP)用于化学品和个人护理产品的分类标识、危害识别、市场监督管理和产品
评价;同时通过增加测试参数、改变暴露时间等方式建立特殊方案的BCOP,并将其用于原料筛
选和安全浓度的确定、配方优化、特殊人群产品测试和口腔黏膜刺激性的评估。结果表明BCOP
方法可以单独使用或者作为整合测试策略的核心方法用于区分刺激性/非刺激性和严重刺激/腐蚀
性,采用特殊方案还可以满足产品差异化、温和宣称的需要。 |
关键词: 个人护理产品 牛角膜浑浊和渗透性实验 替代方法 案例分析 |
DOI:10.13222/j.cnki.dc.2017.03.004 |
分类号: |
基金项目: |
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Case analysis of BCOP in evaluation of personal care products |
QIN Yao1, KE Yi- Hui, CHENG Shu-Jun2, JIN Wei-Hua, HUANG Jian-cong, CHEN Zhi-Jie
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1.Chn-Alt Center for Alternatives Research and Evaluation;2.Guangdong Inspection and Quarantine Technology Center
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Abstract: |
Bovine corneal opacity and permeability (BCOP), a standardized in vitro method for eye irritation, can be used in
classification & labeling, hazard identification, supervision & administration and the evaluation for chemicals and cosmetic products.
Special procedures of BCOP were established by adding testing parameters, changing the exposure time, etc. These modified methods
were used for ingredient selection, safe concentration determination, formulation optimization, product testing for special population
groups and assessment of oral mucous membrane irritation. The results showed that, BCOP could not only be used solely but also as
a core method in the integration testing strategy for distinguishing irritation/ non-irritation and serious irritation/ corrosion. Specially
designed BCOP could also meet the needs for product differentiation and mildness claimed. |
Key words: personal care product BCOP alternative method case analysis |