Skin-on-a-Chip for Cosmetic Safety Assessment: From Reconstructed Skin Models to Regulatory Translation
- 1School of Architectural and Hydraulic Engineering, Jiujiang Polytechnic University of Science and Technology , ,
- 2School of Medicine & Nursing, Huzhou Normal University , No. 759, Erhuan East Road , ,
- 3Institute of Digital Intelligence for Public Health, Huzhou Normal University , No. 759, Erhuan East Road , ,
Abstract
Cosmetic safety assessment increasingly relies on human-relevant nonanimal methods that support mechanistic interpretation and align with a defined decision context. Reconstructed human epidermis (RhE) supports accepted irritation and corrosion procedures. Reconstructed human skin (RhS) and full-thickness equivalents provide tissue-level comparators for dermal architecture, penetration, and recovery. These models are distinct comparator classes. Rather than cataloging skin-on-a-chip (SoC) architectures, this review assigns an appropriate comparator to each cosmetic-safety question. It then defines the residual uncertainty that may justify SoC testing. It also specifies required readouts and evidence thresholds for a prespecified decision. Vascular and immune modules, controlled topical dosing, and multiorgan coupling are considered only when they address unresolved time course, exposure route, tissue context, or mechanism. Decision-ready readouts require traceable calibration, explicit units, prespecified normalization, drift control, variability estimates, comparator agreement, and quantitative acceptance criteria. No reviewed skin SoC has broad regulatory acceptance for routine cosmetic-safety decisions. Translation therefore requires four distinct stages: analytical validation, biological validation, context-of-use qualification, and regulatory acceptance. Current evidence supports SoC mainly as a higher-tier complement when established methods leave a decision-relevant uncertainty.
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BibTeX
@article{zhu2026skinonachip,
title = {{Skin-on-a-Chip for Cosmetic Safety Assessment: From Reconstructed Skin Models to Regulatory Translation}},
author = {Qian Zhu and Wenhui Liu and Xinjie Lv and Xixi Wu},
journal = {ACS Omega},
year = {2026},
month = oct,
doi = {10.1021/acsomega.6c08734},
url = {https://pubs.acs.org/acsodf/article/doi/10.1021/acsomega.6c08734/5457365/Skin-on-a-Chip-for-Cosmetic-Safety-Assessment-From},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Skin-on-a-Chip for Cosmetic Safety Assessment: From Reconstructed Skin Models to Regulatory Translation
AU - Qian Zhu
AU - Wenhui Liu
AU - Xinjie Lv
AU - Xixi Wu
PY - 2026
DA - 2026/10/23
JO - ACS Omega
DO - 10.1021/acsomega.6c08734
UR - https://pubs.acs.org/acsodf/article/doi/10.1021/acsomega.6c08734/5457365/Skin-on-a-Chip-for-Cosmetic-Safety-Assessment-From
AB - Cosmetic safety assessment increasingly relies on human-relevant nonanimal methods that support mechanistic interpretation and align with a defined decision context. Reconstructed human epidermis (RhE) supports accepted irritation and corrosion procedures. Reconstructed human skin (RhS) and full-thickness equivalents provide tissue-level comparators for dermal architecture, penetration, and recovery. These models are distinct comparator classes. Rather than cataloging skin-on-a-chip (SoC) architectures, this review assigns an appropriate comparator to each cosmetic-safety question. It then defines the residual uncertainty that may justify SoC testing. It also specifies required readouts and evidence thresholds for a prespecified decision. Vascular and immune modules, controlled topical dosing, and multiorgan coupling are considered only when they address unresolved time course, exposure route, tissue context, or mechanism. Decision-ready readouts require traceable calibration, explicit units, prespecified normalization, drift control, variability estimates, comparator agreement, and quantitative acceptance criteria. No reviewed skin SoC has broad regulatory acceptance for routine cosmetic-safety decisions. Translation therefore requires four distinct stages: analytical validation, biological validation, context-of-use qualification, and regulatory acceptance. Current evidence supports SoC mainly as a higher-tier complement when established methods leave a decision-relevant uncertainty.
SN - 2470-1343
ER -