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
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摘要
目的探讨在染发类化妆品备案审查中,用牛角膜混浊和渗透性试验(BCOP)代替家兔法(Draize试验)进行眼刺激性评价的可能性。方法分别用BCOP与Draize试验对14种市售染发剂进行眼刺激性评价,并对评价结果进行比较。结果对14种染发剂眼刺激性检测的结果表明,Draize试验所得的刺激反应等级为微刺激性-轻刺激性,按现行评审标准,通过率为100%(14/14);BCOP所得的刺激反应等级为轻微刺激性-严重刺激性,与Draize法分类一致性达到78.6%(11/14),以体外刺激评分值(IVIS)≤25为限值,通过率为78.6%(11/14);以IVIS≤55为限值,通过率为85.7%(12/14)。结论用BCOP代替Draize试验对染发类化妆品进行眼刺激性评价可行。
OBJECTIVE To explore the feasibility of the bovine corneal opacity permeability assay instead of Draize test for eye irritation evaluation of hair dyes. METHODS Fourteen kinds of hair dyes form market were selected to predict ocular irritation by BCOP assay, the calculated in vitro irritancy score(IVIS) were compared with the results of Draize in vivo rabbit test. RESULTS The test results of fourteen kinds of hair dyes products showed that the classification results from Draize test was light-moderate irritation, the passing rate was 100%(14/14) according to current standards, the BCOP assay was slight-severe irritation, the total classification consistency of BCOP and Draize test reached 78.6%(11/14), took the IVIS≤25 as limiting value, the passing rate was 78.6%(11/14); and the passing rate was 85.7%(12/14) when the limiting value was IVIS≤55. CONCLUSION The results suggest that BCOP assay can be used in eye irritation evaluation for hair dyes.
OBJECTIVE To explore the feasibility of the bovine corneal opacity permeability assay instead of Draize test for eye irritation evaluation of hair dyes. METHODS Fourteen kinds of hair dyes form market were selected to predict ocular irritation by BCOP assay, the calculated in vitro irritancy score(IVIS) were compared with the results of Draize in vivo rabbit test. RESULTS The test results of fourteen kinds of hair dyes products showed that the classification results from Draize test was light-moderate irritation, the passing rate was 100%(14/14) according to current standards, the BCOP assay was slight-severe irritation, the total classification consistency of BCOP and Draize test reached 78.6%(11/14), took the IVIS≤25 as limiting value, the passing rate was 78.6%(11/14); and the passing rate was 85.7%(12/14) when the limiting value was IVIS≤55. CONCLUSION The results suggest that BCOP assay can be used in eye irritation evaluation for hair dyes.
引文
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[2]卫生部.化妆品卫生规范.第五:急性眼刺激性/腐蚀性试验[S].2007.
[3]ZHU S M,XIE Z,QU L J,et al.Research on eye irritation using bovine corneal opacity permeability test of hair dyes[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(8):1000-1003.
[4]ZHANG W G,YANG X F,YANG Y,et al.Preliminary study on red blood cell haemolysis assay as an alternative method for eye irritation test[J].Chin Prev Med(中国预防医学杂志),2010,11(6):544-547.
[5]EPA BRD-Final Report.Background review of an in vitro approach for EPA toxicity labeling of anti-microbial cleaning products:EPA toxicity labeling background review document[R].USA:EPA,2009.
[6]HUANG J C,QIN Y,CHRNG S J,et al.Research on eye irritation prediction using bovine corneal opacity permeability test[J].Chin J Health Lab Tec(中国卫生检疫杂志),2014,24(14):1980-1983.