Global Cosmetic Compliance
Intelligence & Solutions
Guideline on Alternative Animal Testing Methods for Skin Corrosion of Cosmetics (In Vitro Skin Corrosion Test Using Reconstructed Human Epidermis)
Local Title:
화장품 등 피부부식 동물대체시험법 가이드라인 화장품 등 피부부식 동물대체시험법 가이드라인
Country/Region:
South Korea
Competent Authority:
National Institute of Food and Drug Safety Evaluation
Type:
Regulation
Status:
In force
Release Date:
2026-04-07
Implementation Date:
2026-04-07
Document
Language Source Title Access
KO
Official Guideline on Alternative Animal Testing Methods for Skin Corrosion of Cosmetics (In Vitro Skin Corrosion Test Using Reconstructed Human Epidermis)
Guideline on Alternative Animal Testing Methods for Skin Corrosion of Cosmetics (In Vitro Skin Corrosion Test Using Reconstructed Human Epidermis)
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Summary

This guideline provides an in vitro skin corrosion test method for cosmetics and other products using a Reconstructed Human Epidermis (RhE) model. It serves as an alternative to animal testing. The method involves applying a test substance to a 3D RhE model, which mimics the human epidermis, and then measuring cell viability using the MTT assay to assess skin corrosion potential. This revised version updates the list of validated test methods, which now include those using the EpiDerm™, SkinEthic™ RHE, epiCS®, and LabCyte EPI-MODEL24 models. The revision was prompted by the discontinuation of the EpiSkin™ model.

History
2026-04-07
Guideline on Alternative Animal Testing Methods for Skin Corrosion of Cosmetics (In Vitro Skin Corrosion Test Using Reconstructed Human Epidermis)
In force
Release Date: 2026-04-07
Implementation Date : 2026-04-07
2019-10-01
User Guide