用于眼睛刺激性化学物质的危险识别和标签的表眼眼睛刺激试验(EIT):固体材料的方案优化和延长运输后的结果

欧盟化妆品指令的第7次修正案和欧盟REACH法规加强了对体外眼部测试方法的需求. 经体外眼毒性试验验证，可预测人体对化学物质的反应, 化妆品和其他消费品需要进行安全评估的材料故意, or inadvertently, 与眼睛接触. 表眼刺激试验(EIT), 使用正常人类细胞为基础的EpiOcular™组织模型, 是为了满足这一需求而开发的. epicular - eit能够区分, 具有较高的灵敏度和精度, 介于眼睛刺激性/腐蚀性材料和不需要标签的材料之间. 尽管最初的EpiOcular-EIT方案在国际上成功地进行了预先验证, 由COLIPA(化妆品欧洲的前身)赞助的多中心研究, 来自两项大型研究(EURL ECVAM-COLIPA验证研究和BASF SE的独立内部验证)的数据表明，该方案对固体的敏感性低于验证管理小组(VMG)设定的眼睛刺激接受标准, 并指出该方法对固体的敏感性有待提高. 通过将固体材料的曝光时间从90分钟增加到6小时, 优化后的EpiOcular-EIT方案达到了100%的灵敏度, 68.4% specificity and 84.6%的准确度，从而满足VMG设定的所有验收标准. In addition, 以满足日本和太平洋地区的需求, EpiOcular-EIT方法在延长组织运输和储存(4-5天)后评估其性能。, 结果证实，该检测方法具有相似的灵敏度, 在这些情况下的特异性和重复性.

眼表刺激试验(EIT), 眼睛刺激测试(EIT), Hazard Identification,  EpiOcular (OCL-200),  Solid test articles, EURL ECVAM, protocol optimization, Long term shipping, Extended storage, Quality control, Historical QC data, assay performance, validation study

Aluminium hydroxide, 50–57%, Chlorhexidine, Quinacrine, Maneb, Phenothiazine, 二水乙二胺四乙酸二钾盐, 2-Mercaptopyrimidine, 1,3-Diiminobenz -isoindoline (f), tetra-Aminopyrimidine硫酸, 2,6-Dichloro-5-fluoro-beta-oxo-3——pyridinepropanoate, Betaine monohydrate, 1-Phenyl-3-pyrazolidinone, Chlorendic anhydride, Dibenzyl phosphate, Gluconolactone, 丙4-hydroxybenzoate, Granuform, Phenylbutazone, Tetraoctylammonium溴化, Camphen, Iminodibenzyl, 2-Aminophenol, Anthracene, 钾tetrafluoroborate, 氢氧化镁, pentahydrate, Ammonium nitrate, m-Dinitrobenzene, 2,3-Dimethyl-2,3-dinitrobutane, Dibenzoyl-L-tartaric酸, 2,4-Dichloro-5-sulphamoylbenzoic酸, 4-Formylbenzoic acid, beta-Resorcylic acid, p-Nitrobenzoic acid, 3,3-Dithiodipropionic酸, 盐酸异丙嗪, 钠monochloroacetate, N,N-Dimethylguanidine硫酸, Sodium oxalate, 4-tert-Butylphenol, Cyclohexanol, n-Hexanol, Butanol, 2-Ethyl-1-hexanol, 聚乙二醇单月桂酸酯, 1-Octanol, Isopropanol, Ethanol (100%) v/v, Ethanol (10%) v/v, 2-Methyl-1-pentanol, Glycerol, 3-Methoxy-1,2-propanediol, 氢氧化钠(1%)w/v, Diethylethanolamine, Methoxyethyl acrylate, Methyl acetate, Methyl cyanoacetate, Ethyl-2-methylacetoacetate, Ethyl acetate, n-Butyl acetate, Iso-octyl acrylate, Ethyl trimethyl acetate, Tetrahydrofuran, 3,3-Dimethylpentane, 3-Methylhexane, 2-Methylpentane, 1,9-Decadiene, Dodecane, 2,6-Dichlorobenzoyl氯, Toluene, Xylene, Methyl cyclopentane, Acetone, 甲基乙基酮(MEK), Methyl amyl ketone, Diisobutyl ketone, Methyl isobutyl ketone, Lactic acid, Triton X-100 (5%), 苯扎氯铵(10%)w/v, 苯扎氯铵(0.01%) w/v，十六烷基溴化吡啶(6%)w/v，吐温20，聚乙二醇400