2016, Vol.10, No.1

Journal of Alternatives to Animal Experiments 2023 KCI Impact Factor : 0.07

pISSN : 1975-9657
https://journal.kci.go.kr/ksaae

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.

Human reconstituted epidermis models have been widely used in evaluating phototoxicity. However, human reconstituted epidermis models made in Korea have not been employed to assess phototoxicity. In this study, we conducted an in vitro phototoxicity test with Neoderm® -E, human reconstituted epidermis model from Korea, in order to see if the model could be used for the evaluation of phototoxicity. Firstly, we performed an UVA sensitivity test and selected 6 J/cm^2 for an UVA irradiation dose. Chlorpromazine as a positive control was then tested to confirm that the substance induces phototoxicity in this model. Afterwards, 3 phototoxins and 2 non-phototoxins were tested using Neoderm® -E and Epiderm TM , a generally used phototoxicity test model, to compare prediction results for each chemical. The results indicated that all those 5 chemicals were correctly predicted with Neoderm® -E, which was accordant with the phototoxic information on them. However, only 3 chemicals were correctly predicted with Epiderm TM . Consequently, the predictive capacity of the test with Neoderm® -E could be higher than that using Epiderm TM . Overall, we reached the conclusion that Neoderm® -E could be used in evaluating phototoxicity.

Various guidelines of alternative test have been published following increased interest in alternative test. Among these guidelines, in vitro skin irritation test is composed of applying a test substance on an artificial human skin model and determining skin irritation measured by cell viability assay using MTT test method. To perform this test to become objectively and reliably, we built all the test procedures following Good Laboratory Practice (GLP). This paper introduces the in vitro skin irritation test method using a human skin model and describes the process how researcher have been through to comply with GLP.