Zeaxanthin: Review of Toxicological Data and Acceptable Daily Intake
Table 2
List of genotoxicity, repeat dose, and reproductive safety studies conducted with DSM-manufactured synthetic zeaxanthin based on international regulatory study designs.
Safety studies
Formulation nominal %
Concentration or dosage
Result
Concentration
Genotoxicity in vitro
Ames, S. typhimurium mutation assay
Crystalline
0, 2.4–1500 g/plate
Negative
Gene mutation in V79 cells
Crystalline
0, 1–16 g/mL
Negative
Unscheduled DNA Synthesis (UDS) in rat hepatocytes
Crystalline
0.1–16 g/mL
Negative
Human lymphocytes
Crystalline
0, 60, and 120 g/mL
Negative
Dose (mg/kg bw/day)
Genotoxicity assays in vivo
Mouse micronucleus
10% beadlet
0, 44.5, 89, and 178
Negative
Subchronic and chronic
13-week oral (admix) in mice
10% beadlet
0, 0, 250, 500, and 1000
NOAEL, high dose
13-week oral (admix) in rats
10% beadlet
0, 0, 250, 500, and 1000
NOAEL, high dose
13-week oral (feed cubes) in dogs
10% beadlet
0, 123, 204, and 422 males : 0, 104, 238, and 442 females
NOAEL, high dose
1-year oral (gavage) in monkeys zeaxanthin or lutein