The OECD Test Guideline (TG) 498 on In Vitro Phototoxicity – Reconstructed Human Epidermis (RhE) Phototoxicity test method was adopted in 2021, including Epiderm RhE model as its Validated Reference Methods (VRM). Document containing Performance Standards based on the VRM was published in 2022 to allow for future inclusion of similar methods (“me-too” methods) in TG 498.
The project to include KeraSkinTM Phototoxicity Assay as a me-too method in TG 498 was included in OECD TG Programme Work Plan in 2024 based on a proposal from Korea. The assay was developed with KeraSkinTM RhE model, which is also already included as a “me-too” method in OECD TG 439 on In Vitro Skin Irritation: RhE Test Method. KoCVAM developed the KeraSkinTM Phototoxicity Assay and coordinated its validation study.
The draft updated Test Guideline 498 is currently under a commenting round by the Working Party of the National Coordinators of the Test Guidelines Programmes and open for comments from the public at the same time. Interested parties are invited to contact their National Coordinators at least a week before 27 January 2026.
