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Me-too validation study for in vitro skin irritation test with a reconstructed human epidermis model, KeraSkin™ for OECD test guideline 439
- Title
- Me-too validation study for in vitro skin irritation test with a reconstructed human epidermis model, KeraSkin™ for OECD test guideline 439
- Authors
- Han J.; Kim S.; Lee S.-H.; Kim J.-S.; Chang Y.J.; Jeong T.-C.; Kang M.-J.; Kim T.-S.; Yoon H.S.; Lee G.Y.; Bae S.; Lim K.-M.
- Ewha Authors
- 배승진; 임경민
- SCOPUS Author ID
- 배승진; 임경민
- Issue Date
- 2020
- Journal Title
- Regulatory Toxicology and Pharmacology
- ISSN
- 0273-2300
- Citation
- Regulatory Toxicology and Pharmacology vol. 117
- Keywords
- KeraSkinTM; OECD TG 439; Predictive capacity; Reconstructed human epidermis; Reproducibility; Skin irritation
- Publisher
- Academic Press Inc.
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- Abstract
- We conducted a me-too validation study to confirm the reproducibility, reliability, and predictive capacity of KeraSkin™ skin irritation test (SIT) as a me-too method of OECD TG 439. With 20 reference chemicals, within-laboratory reproducibility (WLR) of KeraSkin™ SIT in the decision of irritant or non-irritant was 100%, 100%, and 95% while between-laboratory reproducibility (BLR) was 100%, which met the criteria of performance standard (PS, WLR≥90%, BLR≥80%). WLR and BLR were further confirmed with intra-class correlation (ICC, coefficients >0.950). WLR and BLR in raw data (viability) were also shown with a scatter plot and Bland-Altman plot. Comparison with existing VRMs with Bland-Altman plot, ICC and kappa statistics confirmed the compatibility of KeraSkin™ SIT with OECD TG 439. The predictive capacity of KeraSkin™ SIT was estimated with 20 reference chemicals (the sensitivity of 98.9%, the specificity of 70%, and the accuracy of 84.4%) and additional 46 chemicals (for 66 chemicals [20 + 46 chemicals, the sensitivity, specificity and accuracy: 95.2%, 82.2% and 86.4%]). The receiver operating characteristic (ROC) analysis suggested a potential improvement of the predictive capacity, especially sensitivity, when changing cut-off (50% → 60–75%). Collectively, the me-too validation study demonstrated that KeraSkin™ SIT can be a new me-too method for OECD TG 439. © 2020
- DOI
- 10.1016/j.yrtph.2020.104725
- Appears in Collections:
- 약학대학 > 약학과 > Journal papers
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