To study the efficacy of lip moisturizing cosmetics and explore the methods for evaluating their efficacy.The claimed efficacy and number of claimed efficacy of 44 lip moisturizing cosmetics were investigated,and a co...To study the efficacy of lip moisturizing cosmetics and explore the methods for evaluating their efficacy.The claimed efficacy and number of claimed efficacy of 44 lip moisturizing cosmetics were investigated,and a combination of in vitro and human testing was used to evaluate the efficacy of the lip moisturizing cosmetics.The efficacy claims of lip cosmetics mainly included 4 categories of moisturizing,repairing,soothing and anti-wrinkle,with 79.55%of the products claiming 3~4 categories of efficacy.In the in vitro test,the cell morphology of the skin damage model improved and the secretion of pro-inflammatory factors decreased significantly.In the human trial,the water content,skin softness and brightness L value of the cuticle of the lips increased significantly in 31 subjects,and the transepidermal water loss,redness a value,and the area and volume of lip wrinkles decreased significantly;the dryness of the lip skin and the uniformity of the skin texture improved significantly.The dryness of lip skin and the uniformity of skin texture were significantly improved.The results show that the moisture content of the stratum corneum can be used to evaluate the moisturizing efficacy of lip products.The transepidermal water loss,skin color,skin softness and expert assessment can be used to evaluate the repairing efficacy.The observation of cell morphology of skin damage models and the detection of pro-inflammatory factor content can be used to evaluate the soothing efficacy.The area and volume of lip wrinkles can be used to evaluate the anti-wrinkle efficacy of products.展开更多
In vitro skin sensitization testing methods based on the adverse outcome pathway(AOP)were used to evaluate the skin sensitization potencies of 5 commonly used preservatives.According to the“2 out of 3”principle of t...In vitro skin sensitization testing methods based on the adverse outcome pathway(AOP)were used to evaluate the skin sensitization potencies of 5 commonly used preservatives.According to the“2 out of 3”principle of the integrated approaches to testing and assessment(IATA)the direct peptide reactivity assay(DPRA)and the human cell line activation test(h-CLAT)were used to detect the preservatives commonly used in cosmetics,including phenoxyethanol.methyl paraben,propyl paraben,imidazolidinyl urea and DMDM hydantoin.The DPRA and the h-CLA were carried out according to the OEC442C and 442E guidelines,respectively.The results show that.phenoxyethanol and methyl paraben are both negative in DPRA and h-CLAT while imidazolidinyl urea and DMDM hydantoin are both positive in these two tests.Propyl paraben has negative result in DPRA but positive result in h-CLAT.Therefore,imidazolidiny urea and DMDM hydantoin are sensitizers,while phenoxyethanol and methylparaben are non-sensitizers.Taken animal and human data into consideration,it is predicted that propyl paraben should be a non-sensitizer.The combination of DPRA and h-CLAT can make up for the limitations of using a single method,and it is suitable for the preliminary screening of cosmetic raw materials according to skin sensitization.展开更多
In this paper, instrumental analysis techniques for hair fibers and biological models for scalp were introduced as in vitro techniques applied for the efficacy evaluation of hair cosmetics. This review aimed to provid...In this paper, instrumental analysis techniques for hair fibers and biological models for scalp were introduced as in vitro techniques applied for the efficacy evaluation of hair cosmetics. This review aimed to provide reference and guidance for the selection of appropriate in vitro methods to substantiate the performance of various hair cosmetics. The current status and development trends of in vitro evaluation technology for hair cosmetics were summarized and prospected.展开更多
The concept, basic elements, and basic principles of experimental design ofcosmetics human efficacy evaluation were summarized.The commonly used types and key points of experimental design were introduced. The new ide...The concept, basic elements, and basic principles of experimental design ofcosmetics human efficacy evaluation were summarized.The commonly used types and key points of experimental design were introduced. The new idea of the design of cosmetics human efficacy evaluation protocol was proposed to improve the ability of researchers to make a reliable experiment protocol.展开更多
This study evaluated the effect of a fresh-milk cream on reducing skin erythema response in 30 subjects(23.87±0.34 years)by objective instrumental method.The model of skin erythema was established by tape strippi...This study evaluated the effect of a fresh-milk cream on reducing skin erythema response in 30 subjects(23.87±0.34 years)by objective instrumental method.The model of skin erythema was established by tape stripping and histamine stimulation.Herein the skin erythema index(EI),skin sensitivity value and skin images of subjects were measured.The data was statistically analyzed by SPSS software.The results showed that the fresh-milk cream could continuously decrease the value of the histamine-stimulated area’s erythema index and skin sensitivity,and relieve the skin redness.It indicated that the fresh-milk cream had the functions of reducing skin erythema response and soothing the skin sensitivity.展开更多
It reviewed the backgrounds, contents and other aspects of several important cosmetic regulations issued recently, including the Filing of Non-special use Cosmetics in China, Integration of Whitening Cosmetics into Sp...It reviewed the backgrounds, contents and other aspects of several important cosmetic regulations issued recently, including the Filing of Non-special use Cosmetics in China, Integration of Whitening Cosmetics into Specialuse Cosmetics Administration, Inventory of Existing Cosmetic Ingredient in China, Safety and Technical Standards for Cosmetics, Guidance for Safety Risk Assessment of Cosmetics, and Cosmetic Production License Administration, to provide technical support for healthy and ordedy development of the cosmetic industry.展开更多
This paper introduced the development of Technical Safety Standards for Cosmetics(TSSC). It explained changes in TSSC in detail and put forward related suggestions for implementation.
Purpose:This study was designed to determine whether a novel anti-melanogenic agent,PF3758309,has the potential to cause acute cutaneous irritation using a human skin equivalent model (HSEM).Methods:Human skin equival...Purpose:This study was designed to determine whether a novel anti-melanogenic agent,PF3758309,has the potential to cause acute cutaneous irritation using a human skin equivalent model (HSEM).Methods:Human skin equivalent was constructed through incubation of normal human derived epidermal keratinocytes (HEKs)on collagen matrix insert with proliferation media.Using constructed human skin equivalent,the irritation potential of PF3758309 were investigated whether the viability of this agent-treated HESM is under 50%(irritant)or not (non-irritant)using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT)assay after applying the agent to the epidermal surface of the HSEM.Also,the PF3758309-mediated anti-pigmentation effects were analyzed using Fontana-Masson staining in the HSEM.Results:The integrity of the constructed HSEM was confirmed using immunohistochemical staining with differentiation markers of epidermis,and observed that Keratin 5,Keratin I and Involucrin were stained in basal,supra-basal and granular layers,respectively.In vitro irritation assay showed that the mean viabilities of the PF3758309 was 83.6%,78.8%and 77.8%at the treatment doses of 0.2,0.5 and I mg,respectively;however,the mean viability of the positive control (5%sodium dodecyl sulfate)-treated HESM was 2.8%.Also,in vitro corrosion assay showed that the mean viabilities of the PF3758309 was 95.3%,95.0%and 94.2% at the treatment doses of 0.2,0.5 and 1 mg,respectively.Furthermore,using a Fontana-Masson staining assay,the melanin levels in the PF3758309-treated HSEM was significantly decreased compared with the levels in control HSEM.Conclusion: The anti-melanogenic agent,PF3758309,has no skin irritation potential under the conditions used in this study.展开更多
In order to cooperate with the implementation of the relevant cosmetic safety and efficacy evaluation as regulated according to the Regulations on the Supervision and Administration of Cosmetics, the National Medical ...In order to cooperate with the implementation of the relevant cosmetic safety and efficacy evaluation as regulated according to the Regulations on the Supervision and Administration of Cosmetics, the National Medical Products Administration has successively promulgated The Technical Guide of Safety Assessment for Cosmetics and the Standard for Evaluation of Cosmetic Efficacy Claims. This paper comprehensively summarizes the requirements and methods for the evaluation of cosmetic safety and efficacy claims under the new regulations, and puts forward suggestions for relevant enterprises and practitioners, which provides useful guidance and reference for the cosmetic safety and efficacy claim evaluation.展开更多
Regulations for the Supervision and Administration of Cosmetics was promulgated by the State Council on June 29,2020 and will take effect on January 1,2021.Compared with the previous Regulations on Health Supervision ...Regulations for the Supervision and Administration of Cosmetics was promulgated by the State Council on June 29,2020 and will take effect on January 1,2021.Compared with the previous Regulations on Health Supervision of Cosmetics,there are more items proposed for the safety of cosmetics.In this paper,the main changes of the safety supervision of cosmetics by comparing the“new”and“old”regulations were summarized with the potential influences on different groups(government,cosmetic enterprises and consumers)discussed.The important laws and regulations on cosmetic safety and risk assessment in China with recently added in vitro testing methods were summarized and the principal theory of cosmetic quantitative risk assessment was introduced.展开更多
Cosmetic safety evaluation employs a series of toxicological tests, on both qualitative and quantitative levels, to assess the potential risks for the daily use of selected cosmetic ingredients and final products. Tra...Cosmetic safety evaluation employs a series of toxicological tests, on both qualitative and quantitative levels, to assess the potential risks for the daily use of selected cosmetic ingredients and final products. Traditionally, safety evaluation of cosmetics uses animal tests. With the development of in vitro science and the 3R （Reduction, Replacement and Refinement） principle, three-dimensional reconstructed human epidermis （3D-RHE） models have been developed and widely applied in cosmetic safety evaluation. Reconstructed human skin models possess anatomy and metabolism biology similar to real human tissue. This paper reviews the current application of 3D-RHE models in the safety evaluation of skin irritation, eye irritation, phototoxicity and genotoxicity potential of cosmetic ingredients/formulas. The advantages and disadvantages of using skin models are also discussed, and comments and suggestions are given for its future development.展开更多
文摘To study the efficacy of lip moisturizing cosmetics and explore the methods for evaluating their efficacy.The claimed efficacy and number of claimed efficacy of 44 lip moisturizing cosmetics were investigated,and a combination of in vitro and human testing was used to evaluate the efficacy of the lip moisturizing cosmetics.The efficacy claims of lip cosmetics mainly included 4 categories of moisturizing,repairing,soothing and anti-wrinkle,with 79.55%of the products claiming 3~4 categories of efficacy.In the in vitro test,the cell morphology of the skin damage model improved and the secretion of pro-inflammatory factors decreased significantly.In the human trial,the water content,skin softness and brightness L value of the cuticle of the lips increased significantly in 31 subjects,and the transepidermal water loss,redness a value,and the area and volume of lip wrinkles decreased significantly;the dryness of the lip skin and the uniformity of the skin texture improved significantly.The dryness of lip skin and the uniformity of skin texture were significantly improved.The results show that the moisture content of the stratum corneum can be used to evaluate the moisturizing efficacy of lip products.The transepidermal water loss,skin color,skin softness and expert assessment can be used to evaluate the repairing efficacy.The observation of cell morphology of skin damage models and the detection of pro-inflammatory factor content can be used to evaluate the soothing efficacy.The area and volume of lip wrinkles can be used to evaluate the anti-wrinkle efficacy of products.
文摘In vitro skin sensitization testing methods based on the adverse outcome pathway(AOP)were used to evaluate the skin sensitization potencies of 5 commonly used preservatives.According to the“2 out of 3”principle of the integrated approaches to testing and assessment(IATA)the direct peptide reactivity assay(DPRA)and the human cell line activation test(h-CLAT)were used to detect the preservatives commonly used in cosmetics,including phenoxyethanol.methyl paraben,propyl paraben,imidazolidinyl urea and DMDM hydantoin.The DPRA and the h-CLA were carried out according to the OEC442C and 442E guidelines,respectively.The results show that.phenoxyethanol and methyl paraben are both negative in DPRA and h-CLAT while imidazolidinyl urea and DMDM hydantoin are both positive in these two tests.Propyl paraben has negative result in DPRA but positive result in h-CLAT.Therefore,imidazolidiny urea and DMDM hydantoin are sensitizers,while phenoxyethanol and methylparaben are non-sensitizers.Taken animal and human data into consideration,it is predicted that propyl paraben should be a non-sensitizer.The combination of DPRA and h-CLAT can make up for the limitations of using a single method,and it is suitable for the preliminary screening of cosmetic raw materials according to skin sensitization.
基金supported by the National Natural Science Foundation of China (51403006)the Support Project of High-level Teachers in Beijing Municipal Universities in the Period of 13th Five–year Plan (CIT&TCD 201704043)
文摘In this paper, instrumental analysis techniques for hair fibers and biological models for scalp were introduced as in vitro techniques applied for the efficacy evaluation of hair cosmetics. This review aimed to provide reference and guidance for the selection of appropriate in vitro methods to substantiate the performance of various hair cosmetics. The current status and development trends of in vitro evaluation technology for hair cosmetics were summarized and prospected.
文摘The concept, basic elements, and basic principles of experimental design ofcosmetics human efficacy evaluation were summarized.The commonly used types and key points of experimental design were introduced. The new idea of the design of cosmetics human efficacy evaluation protocol was proposed to improve the ability of researchers to make a reliable experiment protocol.
文摘This study evaluated the effect of a fresh-milk cream on reducing skin erythema response in 30 subjects(23.87±0.34 years)by objective instrumental method.The model of skin erythema was established by tape stripping and histamine stimulation.Herein the skin erythema index(EI),skin sensitivity value and skin images of subjects were measured.The data was statistically analyzed by SPSS software.The results showed that the fresh-milk cream could continuously decrease the value of the histamine-stimulated area’s erythema index and skin sensitivity,and relieve the skin redness.It indicated that the fresh-milk cream had the functions of reducing skin erythema response and soothing the skin sensitivity.
文摘It reviewed the backgrounds, contents and other aspects of several important cosmetic regulations issued recently, including the Filing of Non-special use Cosmetics in China, Integration of Whitening Cosmetics into Specialuse Cosmetics Administration, Inventory of Existing Cosmetic Ingredient in China, Safety and Technical Standards for Cosmetics, Guidance for Safety Risk Assessment of Cosmetics, and Cosmetic Production License Administration, to provide technical support for healthy and ordedy development of the cosmetic industry.
文摘This paper introduced the development of Technical Safety Standards for Cosmetics(TSSC). It explained changes in TSSC in detail and put forward related suggestions for implementation.
文摘Purpose:This study was designed to determine whether a novel anti-melanogenic agent,PF3758309,has the potential to cause acute cutaneous irritation using a human skin equivalent model (HSEM).Methods:Human skin equivalent was constructed through incubation of normal human derived epidermal keratinocytes (HEKs)on collagen matrix insert with proliferation media.Using constructed human skin equivalent,the irritation potential of PF3758309 were investigated whether the viability of this agent-treated HESM is under 50%(irritant)or not (non-irritant)using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT)assay after applying the agent to the epidermal surface of the HSEM.Also,the PF3758309-mediated anti-pigmentation effects were analyzed using Fontana-Masson staining in the HSEM.Results:The integrity of the constructed HSEM was confirmed using immunohistochemical staining with differentiation markers of epidermis,and observed that Keratin 5,Keratin I and Involucrin were stained in basal,supra-basal and granular layers,respectively.In vitro irritation assay showed that the mean viabilities of the PF3758309 was 83.6%,78.8%and 77.8%at the treatment doses of 0.2,0.5 and I mg,respectively;however,the mean viability of the positive control (5%sodium dodecyl sulfate)-treated HESM was 2.8%.Also,in vitro corrosion assay showed that the mean viabilities of the PF3758309 was 95.3%,95.0%and 94.2% at the treatment doses of 0.2,0.5 and 1 mg,respectively.Furthermore,using a Fontana-Masson staining assay,the melanin levels in the PF3758309-treated HSEM was significantly decreased compared with the levels in control HSEM.Conclusion: The anti-melanogenic agent,PF3758309,has no skin irritation potential under the conditions used in this study.
文摘In order to cooperate with the implementation of the relevant cosmetic safety and efficacy evaluation as regulated according to the Regulations on the Supervision and Administration of Cosmetics, the National Medical Products Administration has successively promulgated The Technical Guide of Safety Assessment for Cosmetics and the Standard for Evaluation of Cosmetic Efficacy Claims. This paper comprehensively summarizes the requirements and methods for the evaluation of cosmetic safety and efficacy claims under the new regulations, and puts forward suggestions for relevant enterprises and practitioners, which provides useful guidance and reference for the cosmetic safety and efficacy claim evaluation.
文摘Regulations for the Supervision and Administration of Cosmetics was promulgated by the State Council on June 29,2020 and will take effect on January 1,2021.Compared with the previous Regulations on Health Supervision of Cosmetics,there are more items proposed for the safety of cosmetics.In this paper,the main changes of the safety supervision of cosmetics by comparing the“new”and“old”regulations were summarized with the potential influences on different groups(government,cosmetic enterprises and consumers)discussed.The important laws and regulations on cosmetic safety and risk assessment in China with recently added in vitro testing methods were summarized and the principal theory of cosmetic quantitative risk assessment was introduced.
文摘Cosmetic safety evaluation employs a series of toxicological tests, on both qualitative and quantitative levels, to assess the potential risks for the daily use of selected cosmetic ingredients and final products. Traditionally, safety evaluation of cosmetics uses animal tests. With the development of in vitro science and the 3R （Reduction, Replacement and Refinement） principle, three-dimensional reconstructed human epidermis （3D-RHE） models have been developed and widely applied in cosmetic safety evaluation. Reconstructed human skin models possess anatomy and metabolism biology similar to real human tissue. This paper reviews the current application of 3D-RHE models in the safety evaluation of skin irritation, eye irritation, phototoxicity and genotoxicity potential of cosmetic ingredients/formulas. The advantages and disadvantages of using skin models are also discussed, and comments and suggestions are given for its future development.
