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Chung, Hyewon,Quan, Hailian,Jung, Daun,Ravi, Gautam,Cho, Ahrang,Kang, Mi Jeong,Kim, Eunju,Che, Jeong-Hwan,Lee, Eung-Seok,Jeong, Tae Cheon,Heo, Yong,Seok, Seung Hyeok Elsevier 2018 Toxicology in vitro Vol.46 No.-
<P><B>Abstract</B></P> <P>Due to considerable constraints in using animals for risk assessment, much effort has been directed at developing non-animal test methods. Developing assays for skin sensitization, the leading cause of contact dermatitis, is particularly important, but there are currently no <I>in vitro</I> skin sensitization tests that completely replace animal tests.</P> <P>HaCaSens, a simple skin sensitization test using non-transformed HaCaT cells, predicts keratinocyte activation by skin sensitizers with 75% sensitivity, 83% specificity and 77% accuracy in a previous study using 22 coded substances. Although the data show promising results, the number of tested substances is insufficient to prove predictive capacity. Moreover, reproducibility among different laboratories has not been studied.</P> <P>Here, three laboratories participated in a validation in order to assess HaCaSens feasibility for official validation. To examine transferability, intra- and inter-lab reproducibility and predictive capacity, HaCaSens was assessed on a set of 30 test substances coordinated by the Validation Management Team (VMT). The results showed satisfactory transferability as well as intra- and inter-laboratory reproducibility. Further assessment of its predictive capacity on 20 test substances demonstrated a sensitivity of 81.8% (18/22), specificity of 87.5% (7/8), and accuracy of 83.3% (25/30) in identifying skin sensitizers, which is comparable with presently validated assays, KeratinoSens™ and LuSens.</P> <P>This validation study shows that the HaCaSens assay is easily transferable, reproducible and highly predictable for identifying skin sensitizers.</P> <P><B>Highlights</B></P> <P> <UL> <LI> HaCaSens assay is performed in three laboratories with a set of 30 test substances. </LI> <LI> Intra- and inter-laboratory validation shows satisfactory accuracy over 83%. </LI> <LI> Compared with other similar assays, the HaCaSens acquired better accuracy. </LI> <LI> This study can be a reliable support for proposing HaCaSens as a promising assay. </LI> </UL> </P>
오한슬 ( Hanseul Oh ),김시윤 ( C-yoon Kim ),한주희 ( Ju-hee Han ),김진 ( Jin Kim ),이은혜 ( Eunhye Lee ),전혜련 ( Hailian Quan ),석승혁 ( Seung Hyeok Seok ),정초록 ( Cho-rok Jung ),박재학 ( Jae-hak Park ) 한국동물실험대체법학회 2016 동물실험대체법학회지 Vol.10 No.1
The global cosmetic market in 2014 was estimated to be worth to about 250 billion USD and has continued to grow. In particular, stem-cell based cosmetics, which can be used to repair skin and protect it from aging, have become recently trendy. However, the questionable safety issue of commercial stem-cell cosmetics has become a hot issue. Cosmetics consumers may buy a product without any information about the safety of products whose ingredients may have less than 10 years of commercial history. For the safety verification of cosmetics and ingredients, the classification for eye irritation needs to be conducted essentially. The Bovine Corneal Opacity & Permeability test (BCOP) is recommended as a validated alternative method for eye irritation by the Organization for Economic Co-operation and Development (OECD). Thus, in this study, we evaluated the eye irritation potential of commercial stem-cell based cosmetics by the BCOP assay, Hens Egg Test on the Chorio-Allantoic Membrane (HET-CAM) assay, and Human Umbilical Vein Endothelial cell (HUVEC) test. Our results showed that all 8 test substances were not classified as eye irritants which could cause serious eye damage according to the BCOP assay associated with histopathology and the HET-CAM assay. But four test substances showed to be mild irritants in the HUVEC test. To the best of our knowledge, our results are the first reported data about the classification of the potential eye irritation of stem-cell based cosmetics, and demonstrate that the validated BCOP assay combined with other alternative tests such as the HET-CAM assay and the HUVEC test, may be able to indicate mild to serious eye irritants.