Product Description

Phototoxicity is a critical safety concern for cosmetics and pharmaceuticals exposed to UV light. Regulatory authorities (NMPA, OECD, EMA, ICH) require phototoxicity data, and the 3T3 NRU assay is the first in vitro alternative validated by ECVAM and adopted as OECD TG 432, replacing traditional animal tests.

The assay measures cytotoxicity of test compounds with and without UV irradiation on BALB/c 3T3 fibroblasts. Cell viability is quantified by neutral red uptake, and the Photoirritation Factor (PIF) and Mean Photo Effect (MPE) are calculated using Phototox 2.0 to classify phototoxic potential per OECD criteria.

ScreeNingBio (SNB) has established and validated this assay in full compliance with OECD 432 and INVITTOX 78, using the recommended cell line (ATCC CCL‑163), solar simulator, and strict quality controls (chlorpromazine as positive control). Our platform delivers robust, reproducible, and traceable results, supporting regulatory submissions for cosmetic ingredients, finished products, and drug candidates worldwide.