三维重组人工皮肤模型在化妆品安全性评价中的应用
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- 英文论文题名：Safety Evaluation of Cosmetics based on In Vitro three-dimensional reconstructed human epidermis(3D-RHE) models
- 论文作者：孔雪 ; 聂鹏举 ; 何文丹 ; 唐颖
- 英文论文作者：KONG Xue ; NIE Peng-Ju ; HE Wen-Dan ; TANG Ying ; China Cosmetic Collaborative Innovation Center/Beijing Key Lab of Plant Resource Research and Development/Department of cosmetics ; School of Science ; Beijing Technology and Business University
- 年：2016
- 作者机构：中国化妆品创新协同中心/北京市植物资源研究开发重点实验室/北京工商大学理学院化妆品系;
- 论文关键词：三维重组人工皮肤模型 ; 化妆品安全 ; 体外毒理学 ; 动物替代方法
- 英文论文关键词：three-dimensional reconstructed human epidermis models ; cosmetic safety ; in vitro toxicity ; animal alternative methods
- 会议召开时间：2016-06-15
- 会议录名称：第十一届中国化妆品学术研讨会论文集
- 英文会议录名称：The Proceedings of the 11th Seminar on Cosmetic China
- 语种：中文
- 分类号：TQ658
- 学会代码：ZGXE
- 会议名称：第十一届中国化妆品学术研讨会
- 会议地点：中国上海
- 主办单位：中国香料香精化妆品工业协会
- 学会名称：中国香料香精化妆品工业协会
- 页数：8
- 文件大小：487k
- 原文格式：O
- 会议级别：全国
摘要
化妆品安全性评价是对化妆品进行从原料选用到准投放市场产品的潜在不良反应进行定性和定量的毒理学评价。传统的化妆品安全性评价主要采用动物试验,随着科学技术的发展和3R(减少、替代和优化)原则的推动,三维重组人工皮肤模型因具有与人类皮肤相似的生理结构和代谢功能而在的毒理学研究中获得了广泛的发展。本文主要综述了三维重组人工皮肤模型在化妆品皮肤刺激/腐蚀性评价、眼刺激性评价、光毒性评价和遗传毒性评价方面的应用现状,分析了皮肤模型的优缺点,并对其在化妆品安全性评价中的应用前景以及发展策略提出了意见和建议。
Cosmetics safety evaluation is employing a series of toxicological tests,on both qualitative and quantative levels,to assess the potential risks for the daily use of selected cosmetic ingredients and final products.Traditional safety evaluation is mainly using animal tests.With the development of in vitro science and 3Rs(Reduction,Replacement and Refinement) principle,three-dimensional reconstructed human epidermis models have been developed and applied in cosmetic safety evaluation.Reconstructed human skin models possess anatomy and metabolism biology similar to real human.This paper reviews the current status of three-dimensional reconstructed human epidermis models applied in skin irritation/corrosion,eye irritation,photo-toxicity and genotoxicity assessment of cosmetics.The advantages and disadvantages of using skin models are also discussed with comments and suggestions for its future development.
Cosmetics safety evaluation is employing a series of toxicological tests,on both qualitative and quantative levels,to assess the potential risks for the daily use of selected cosmetic ingredients and final products.Traditional safety evaluation is mainly using animal tests.With the development of in vitro science and 3Rs(Reduction,Replacement and Refinement) principle,three-dimensional reconstructed human epidermis models have been developed and applied in cosmetic safety evaluation.Reconstructed human skin models possess anatomy and metabolism biology similar to real human.This paper reviews the current status of three-dimensional reconstructed human epidermis models applied in skin irritation/corrosion,eye irritation,photo-toxicity and genotoxicity assessment of cosmetics.The advantages and disadvantages of using skin models are also discussed with comments and suggestions for its future development.
引文
[1]马来记,魏少敏.化妆品安全评价进展[C].2004年中国化妆品学术研讨会.2004:8~12.
[2]Pauwels M,Rogiers V.Safety evaluation of cosmetics in the EU:reality and challenges for the toxicologist[J].Toxicology letters,2004,151(1):7-17.
[3]张春晓,杜镇建,张兴民,等.3D-人造皮肤模型在化妆品安全性、功效性评价中的应用[J].中国化妆品,2014,2:38~40.
[4]Gordon S,Daneshian M,Bouwstra J,etc.Non-animal models of epithelial barriers(skin,intestine and lung)in research,industrial applications and regulatory toxicology[J].Alternatives to Animal Experimentation,2015,32(4):327-378.
[5]程树军,焦红.实验动物替代方法原理与应用[M].北京:科学出版社,2010:188~340.
[6]安子扬.皮肤模型的构建及在检测药物化妆品中的应用[D].河北农业大学硕士论文,2013.
[7]Kandarova H,Hayden P,Klausner M,etc.An In Vitro Skin Irritation Test(SIT)using the EpiDerm Reconstructed Human Epidermal(RHE)Model[J].Electrophoresis,2009,(29):1366.
[8]Kaluzhny Y,Kandarova H,Hayden P,etc.Development of the EpiOcular~(TM)Eye Irritation Test(EpiOcular-EIT)for hazard identification and labelling of eye irritating chemicals in response to the requirements of the cosmetics directive and REACH legislation[J].Alternatives to laboratory animals,2015,43(2):101-127.
[9]JírováD,KejlováK,BendováH,etc.Phototoxicity of bituminous tars—correspondence between results of 3T3 NRU PT,3D skin model and experimental human data[J].Toxicology in Vitro,2005,19(7):931-934.
[10]Reus AA,Reisinger K,Downs TR,etc.Comet assay in reconstructed 3D human epidermal skin models—investigation of intra-and inter-laboratory reproducibility with coded chemicals[J].Mutagenesis,2013,28(6):709-720.
[11]Bernhofer LP,Seiberg M,Martin KM.The influence of the Response of skin equivalents systems to topically applied consumer Products by epithelial mesenchymal interaction[J].Toxicology in Vitro,1999,13:219-229.
[12]中华人民共和国卫生部.化妆品安全技术规范[S].2015.
[13]Test No.404:Acute Dermal Irritation/Corrosion[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-13.
[14]Test No.439:In Vitro Skin Irritation:Reconstructed Human Epidermis Test Method[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-18.
[15]Costin GE,Raabe H,Curren R.In Vitro Safety Testing Strategy for Skin Irritation Using The 3D Reconstructed Human Epidermis[J].Romanian Journal of Biochemistry,2009,46(2):165-186.
[16]Spiekstra SW,Dos Santos GG,Scheper RJ,etc.Potential method to determine irritant potency in vitro-Comparison of two reconstructed epidermal culture models with different barrier competency[J].Toxicology In vitro,2009,23(2):349-355.
[17]Test No.492:Reconstructed human Cornea-like Epithelium(RhCE)test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage[J].OECD Guidelines for the Testing of Chemicals,2015:1-27.
[18]Test No.437:Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-18.
[19]Test No.438:Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants[S].OECD Guidelines for the Testing of Chemicals,2010,1:1-18.
[20]European Union Reference Laboratory for Alternatives to Animal Testing(EUAL ECVAM):Validation®ulatory acceptance:Topical toxicity:Eye Irritation.
[21]Test No.460:Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants[S].OECD Guidelines for the Testing of Chemicals,2012,1:1-16.
[22]Kaluzhny Y,Kandarova H,d'Argembeau-Thornton L,etc.Eye Irritation Test(EIT)for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial(RhCE)Tissue Model[J].Journal of Visualized Experiments,2015(102):e52979-e52979.
[23]Pfannenbecker U,Bessou-Touya S,Faller C,etc.Cosmetics Europe multi-laboratory pre-validation of the EpiOcular?reconstituted human tissue test method for the prediction of eye irritation[J].Toxicology In Vitro,2013,27(2):619-626.
[24]Alepee N,Bessou-Touya S,Cotovio J,etc.Cosmetics Europe multi-laboratory pre-validation of the SkinEthic~(TM)reconstituted human corneal epithelium test method for the prediction of eye irritation[J].Toxicology in Vitro,2013,27(5):1476-1488.
[25]Test No.432:In Vitro 3T3 NRU Phototoxicity Test[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-15.
[26]邹运动,曹玉萍,郑洪艳,等.基于组织工程皮肤的化学品光毒性检测[J].中国组织工程研究与临床康复,2009,13(11):2147~2150.
[27]Lee JH,Kim JE,Kim BJ,etc.In vitro phototoxicity test using artificial skin with melanocytes[J].Photodermatology Photoimmunology&Photomedicine,2007;23(2-3):73-80.
[28]Lelievre D,Justine P,Christiaens F,etc.The EpiSkin phototoxicity assay(EPA):development of an in vitro tiered strategy using 17 reference chemicals to predict phototoxic potency[J].Toxicology In vitro,2007,21(6):977-995.
[29]卢永波,张荣芳,许珊珊,等.一种用于体外测试的中国汉族人表皮替代模型[J].中国药理学与毒理学杂志,2013,27(S1):310~310.
[30]Park YH,Jeong SH,Yi SM,etc.Analysis for the potential of polystyrene and TiO2 nanoparticles to induce skin irritation,phototoxicity,and sensitization[J].Toxicology in Vitro,2011,25(8):1863-1869.
[31]Bernard FX,Barrault C,Deguercy A,etc.Development of a highly sensitive in vitro phototoxicity assay using the SkinEthic~(TM)reconstructed human epidermis[J].Cell Biology and Toxicology.2000,16(6):391-400.
[32]Pfuhler S,Kirst A,Aardema M,etc.A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics:Genotoxicity.A COLIPA analysis[J].Regulatory Toxicology and Pharmacology.2010,57(2-3):315-324.
[33]Kirkland D,Aardema M,Henderson L,etc.Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens:I.Sensitivity,specificity and relative predictivity[J].Mutation Research,2005,584(1-2):1-256.
[34]Pfuhler S,Fautz R,Ouedraogo G,etc.The cosmetics Europe strategy for animal-free genotoxicity testing:project status up-date[J].Toxicology in Vitro,2014,28(1):18-23.
[35]Mun GC,Aardema MJ,Hu T,etc.Further development of the EpiDerm 3D reconstructed human skin micronucleus(RSMN)assay[J].Mutation Research/Genetic Toxicology and Environmental Mutagenesis,2009,673(2):92-99.
[36]Hu T,Kaluzhny Y,Mun GC,etc.Intralaboratory and interlaboratory evaluation of the EpiDermTM3D human reconstructed skin micronucleus(RSMN)assay[J].Mutation Research,2009,673(2):100-108.
[2]Pauwels M,Rogiers V.Safety evaluation of cosmetics in the EU:reality and challenges for the toxicologist[J].Toxicology letters,2004,151(1):7-17.
[3]张春晓,杜镇建,张兴民,等.3D-人造皮肤模型在化妆品安全性、功效性评价中的应用[J].中国化妆品,2014,2:38~40.
[4]Gordon S,Daneshian M,Bouwstra J,etc.Non-animal models of epithelial barriers(skin,intestine and lung)in research,industrial applications and regulatory toxicology[J].Alternatives to Animal Experimentation,2015,32(4):327-378.
[5]程树军,焦红.实验动物替代方法原理与应用[M].北京:科学出版社,2010:188~340.
[6]安子扬.皮肤模型的构建及在检测药物化妆品中的应用[D].河北农业大学硕士论文,2013.
[7]Kandarova H,Hayden P,Klausner M,etc.An In Vitro Skin Irritation Test(SIT)using the EpiDerm Reconstructed Human Epidermal(RHE)Model[J].Electrophoresis,2009,(29):1366.
[8]Kaluzhny Y,Kandarova H,Hayden P,etc.Development of the EpiOcular~(TM)Eye Irritation Test(EpiOcular-EIT)for hazard identification and labelling of eye irritating chemicals in response to the requirements of the cosmetics directive and REACH legislation[J].Alternatives to laboratory animals,2015,43(2):101-127.
[9]JírováD,KejlováK,BendováH,etc.Phototoxicity of bituminous tars—correspondence between results of 3T3 NRU PT,3D skin model and experimental human data[J].Toxicology in Vitro,2005,19(7):931-934.
[10]Reus AA,Reisinger K,Downs TR,etc.Comet assay in reconstructed 3D human epidermal skin models—investigation of intra-and inter-laboratory reproducibility with coded chemicals[J].Mutagenesis,2013,28(6):709-720.
[11]Bernhofer LP,Seiberg M,Martin KM.The influence of the Response of skin equivalents systems to topically applied consumer Products by epithelial mesenchymal interaction[J].Toxicology in Vitro,1999,13:219-229.
[12]中华人民共和国卫生部.化妆品安全技术规范[S].2015.
[13]Test No.404:Acute Dermal Irritation/Corrosion[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-13.
[14]Test No.439:In Vitro Skin Irritation:Reconstructed Human Epidermis Test Method[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-18.
[15]Costin GE,Raabe H,Curren R.In Vitro Safety Testing Strategy for Skin Irritation Using The 3D Reconstructed Human Epidermis[J].Romanian Journal of Biochemistry,2009,46(2):165-186.
[16]Spiekstra SW,Dos Santos GG,Scheper RJ,etc.Potential method to determine irritant potency in vitro-Comparison of two reconstructed epidermal culture models with different barrier competency[J].Toxicology In vitro,2009,23(2):349-355.
[17]Test No.492:Reconstructed human Cornea-like Epithelium(RhCE)test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage[J].OECD Guidelines for the Testing of Chemicals,2015:1-27.
[18]Test No.437:Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-18.
[19]Test No.438:Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants[S].OECD Guidelines for the Testing of Chemicals,2010,1:1-18.
[20]European Union Reference Laboratory for Alternatives to Animal Testing(EUAL ECVAM):Validation®ulatory acceptance:Topical toxicity:Eye Irritation.
[21]Test No.460:Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants[S].OECD Guidelines for the Testing of Chemicals,2012,1:1-16.
[22]Kaluzhny Y,Kandarova H,d'Argembeau-Thornton L,etc.Eye Irritation Test(EIT)for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial(RhCE)Tissue Model[J].Journal of Visualized Experiments,2015(102):e52979-e52979.
[23]Pfannenbecker U,Bessou-Touya S,Faller C,etc.Cosmetics Europe multi-laboratory pre-validation of the EpiOcular?reconstituted human tissue test method for the prediction of eye irritation[J].Toxicology In Vitro,2013,27(2):619-626.
[24]Alepee N,Bessou-Touya S,Cotovio J,etc.Cosmetics Europe multi-laboratory pre-validation of the SkinEthic~(TM)reconstituted human corneal epithelium test method for the prediction of eye irritation[J].Toxicology in Vitro,2013,27(5):1476-1488.
[25]Test No.432:In Vitro 3T3 NRU Phototoxicity Test[S].OECD Guidelines for the Testing of Chemicals,2010,1(4):1-15.
[26]邹运动,曹玉萍,郑洪艳,等.基于组织工程皮肤的化学品光毒性检测[J].中国组织工程研究与临床康复,2009,13(11):2147~2150.
[27]Lee JH,Kim JE,Kim BJ,etc.In vitro phototoxicity test using artificial skin with melanocytes[J].Photodermatology Photoimmunology&Photomedicine,2007;23(2-3):73-80.
[28]Lelievre D,Justine P,Christiaens F,etc.The EpiSkin phototoxicity assay(EPA):development of an in vitro tiered strategy using 17 reference chemicals to predict phototoxic potency[J].Toxicology In vitro,2007,21(6):977-995.
[29]卢永波,张荣芳,许珊珊,等.一种用于体外测试的中国汉族人表皮替代模型[J].中国药理学与毒理学杂志,2013,27(S1):310~310.
[30]Park YH,Jeong SH,Yi SM,etc.Analysis for the potential of polystyrene and TiO2 nanoparticles to induce skin irritation,phototoxicity,and sensitization[J].Toxicology in Vitro,2011,25(8):1863-1869.
[31]Bernard FX,Barrault C,Deguercy A,etc.Development of a highly sensitive in vitro phototoxicity assay using the SkinEthic~(TM)reconstructed human epidermis[J].Cell Biology and Toxicology.2000,16(6):391-400.
[32]Pfuhler S,Kirst A,Aardema M,etc.A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics:Genotoxicity.A COLIPA analysis[J].Regulatory Toxicology and Pharmacology.2010,57(2-3):315-324.
[33]Kirkland D,Aardema M,Henderson L,etc.Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens:I.Sensitivity,specificity and relative predictivity[J].Mutation Research,2005,584(1-2):1-256.
[34]Pfuhler S,Fautz R,Ouedraogo G,etc.The cosmetics Europe strategy for animal-free genotoxicity testing:project status up-date[J].Toxicology in Vitro,2014,28(1):18-23.
[35]Mun GC,Aardema MJ,Hu T,etc.Further development of the EpiDerm 3D reconstructed human skin micronucleus(RSMN)assay[J].Mutation Research/Genetic Toxicology and Environmental Mutagenesis,2009,673(2):92-99.
[36]Hu T,Kaluzhny Y,Mun GC,etc.Intralaboratory and interlaboratory evaluation of the EpiDermTM3D human reconstructed skin micronucleus(RSMN)assay[J].Mutation Research,2009,673(2):100-108.