Nomination Summary for D & C Red (no. 27 & 28) (N20102)
Nomination Date: 10/00/2000
Rationale: The FDA nominated D & C Red 27 & 28 for percutaneous absorption and subsequent photocarcinogenicity studies if percutaneous absorption is significant. Concern about photocarcinogenicity is related to the photodynamic activity of these dyes. These dyes photosensitize the formation of reactive oxygen species and also photosensitize damage to DNA. Structurally related halogenated fluorescein dyes have been found to be photogenotoxic. There is a lack of long-term phototoxicity/photocarcinogenicity data.