title: Evaluation of the in vivo genotoxicity of Allura Red AC (Food Red No. 40).
abstract: Allura Red AC (Food Red No. 40) is a red azo dye that is used for food coloring in beverage and confectionary products. However, its genotoxic properties remain controversial. To clarify the in vivo genotoxicity, we treated mice with Allura Red AC and investigated the induction of DNA damage (liver, glandular stomach), clastogenicity/anuegenicity (bone marrow), and mutagenicity (liver, glandular stomach) using Comet assays, micronucleus tests, and transgenic gene mutation assays, respectively. All studies were conducted in accordance with the Organization for Economic Co-operation and Development (OECD) guideline. Although Allura Red AC was administered up to the maximum doses recommended by the OECD guideline, no genotoxic effect was observed in any of the genotoxic endpoints. These data clearly show no evidence of in vivo genotoxic potential of Allura Red AC administered up to the maximum doses in mice.
authors.affiliation: Division of Genetics and Mutagenesis, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan. Electronic address: honma@nihs.go.jp.
authors.forename: Masamitsu
authors.initials: M
authors.lastname: Honma
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001391:Azo Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D020552:Comet Assay; D003433:Crosses, Genetic; D004249:DNA Damage; D005505:Food Coloring Agents / Q000008:administration & dosage / Q000009:adverse effects*; D007564:Japan; D008297:Male; D051379:Mice; D008815:Mice, Inbred Strains; D008817:Mice, Mutant Strains; D008822:Mice, Transgenic; D015162:Micronucleus Tests; D009152:Mutagenicity Tests
chemical_list: D001391:Azo Compounds; D005505:Food Coloring Agents; C005915:Allura Red AC Dye
keywords: Allura Red AC (Food Red No. 40); Comet assay; Micronucleus test; OECD guidelines; Transgenic gene mutation assay