title: KeraSkin-VM: a novel reconstructed human epidermis model for skin irritation tests.
abstract: Several alternative in vitro methods to evaluate skin irritants have been developed recently. In July 2010, OECD officially endorsed the validated reference method (VRM) that uses reconstituted human epidermis (RhE) models as replacements for the in vivo skin irritation test. This study evaluated the KeraSkin-VM model, a novel human epidermis model that was reconstructed with Asian skin tissue using 20 reference chemicals according to the OECD TG 439 performance standard. The test chemicals were applied to the epidermal surface side for 45 min and then rinsed, and then incubated for 42 h post-treatment. An overall accuracy of 80%, sensitivity of 90% and specificity of 70% were obtained when the results from KeraSkin-VM were compared with UN GHS categories, which was comparable to the EpiDerm Skin irritation test (SIT) rates. Furthermore, KeraSkin-VM demonstrated good performance in terms of within-laboratory reproducibility and predictive capacity to screen skin irritants.
authors.affiliation: Amorepacific Co. R&D Center, Yongin 446-729, Republic of Korea.
authors.forename: Kyoung-Mi
authors.initials: KM
authors.lastname: Jung
authors.affiliation: Modern Cell & Tissue Technologies Inc., Seoul 139-743, Republic of Korea.
authors.forename: Su-Hyon
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Amorepacific Co. R&D Center, Yongin 446-729, Republic of Korea.
authors.forename: Won-Hee
authors.initials: WH
authors.lastname: Jang
authors.affiliation: Modern Cell & Tissue Technologies Inc., Seoul 139-743, Republic of Korea.
authors.forename: Haeng-Sun
authors.initials: HS
authors.lastname: Jung
authors.affiliation: Department of Occupational Health, College of Natural Sciences, Catholic University of Daegu, Daegu 712-702, Republic of Korea.
authors.forename: Yong
authors.initials: Y
authors.lastname: Heo
authors.affiliation: Amorepacific Co. R&D Center, Yongin 446-729, Republic of Korea.
authors.forename: Young-Ho
authors.initials: YH
authors.lastname: Park
authors.affiliation: College of Pharmacology, Ewha Womans University, Seoul 120-808, Republic of Korea.
authors.forename: SeungJin
authors.initials: S
authors.lastname: Bae
authors.affiliation: College of Pharmacology, Ewha Womans University, Seoul 120-808, Republic of Korea. Electronic address: kmlim@ewha.ac.kr.
authors.forename: Kyung-Min
authors.initials: KM
authors.lastname: Lim
authors.affiliation: Department of Microbiology and Immunology, and Institute of Endemic Disease, Seoul National University Medical College, Seoul 110-799, Republic of Korea. Electronic address: lamseok@snu.ac.kr.
authors.forename: Seung Hyeok
authors.initials: SH
authors.lastname: Seok
mesh_terms: D004817:Epidermis / Q000187:drug effects*; D052816:Foreskin; D006801:Humans; D066298:In Vitro Techniques; D007509:Irritants / Q000633:toxicity*; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D023422:Skin Irritancy Tests / Q000379:methods*
chemical_list: D007509:Irritants
keywords: Accuracy; Keraskin™-VM; Reconstructed human skin; Sensitivity; Skin irritation; Specificity