Me-too validation study for in vitro skin irritation test with a reconstructed human epidermis model, KeraSkin™ for OECD test guideline 439

Juhee Han, Seolyeong Kim, Su Hyun Lee, Jin Sik Kim, Yu Jin Chang, Tae Cheon Jeong, Mi Jeong Kang, Tae Sung Kim, Hae Seong Yoon, Ga Young Lee, Seung Jin Bae, Kyung Min Lim

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish
Article number104725
JournalRegulatory Toxicology and Pharmacology
Volume117
DOIs
StatePublished - Nov 2020

Keywords

  • KeraSkin
  • OECD TG 439
  • Predictive capacity
  • Reconstructed human epidermis
  • Reproducibility
  • Skin irritation

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