Testing of 24 food, drug, cosmetic, and fabric dyes in the in vitro and the in vivo/in vitro rat hepatocyte primary culture/DNA repair assays.

Twenty-four dyes currently or previously used in the food, drug, cosmetic, and textile industries were tested in the in vitro rat hepatocyte primary culture/DNA repair (HPC/DR) assay and, to a limited extent, in the in vivo/in vitro HPC/DR assay. The positive control, Solvent Yellow 3 (o-aminoazotoluene), and five other dyes (4-dimethylaminobenzeneazo-1-naphthalene, 4-dimethylaminobenzeneazo-2-naphthalene, Direct Blue 53, Acid Blue 9, and 4-dimethylaminostilbene) induced DNA repair in rat hepatocytes both in vitro and in vivo, while 13 of the dyes (Food Red 1, Food Red 5, Food Orange 4, Food Red 7, Acid Red 14, Acid Red 27, Pigment Red 53, Acid Yellow 23, Food Black 1, Food Green 3, Acid Red 51, Acid Blue 74, and Natural Red 4) did not produce any detectable DNA repair in either the in vitro or in vivo/in vitro assays. Direct Blue 14 had weak activity in vitro but none was detected in vivo. In contrast, Solvent Yellow 5 was not active in vitro, but produced a weak positive response in vivo. Negative responses were also obtained for Solvent Yellow 14 and Acid Green 5 in the in vitro assay, whereas the responses produced by these dyes in the in vivo/in vitro assay were judged to be equivocal. An equivocal response was also obtained for Direct Red 28 in the in vivo/in vitro assay as well as in the in vitro assay. These findings provide information about the potential genotoxicity of a number of dyes for which previous genotoxicity data has been inconsistent or inadequate. For some dyes (eg, Solvent Yellow 5), discrepancies between the results obtained in the in vitro and in vivo/in vitro assays may implicate a role for intestinal microflora in their metabolic activation.