| Safety studies | Formulation nominal % | Concentration or dosage concentration | Result |
| 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 | 10% beadlet | 0, 0.2, and 20 for zeaxanthin or lutein | NOAEL, high dose | Reproductive studies | | | | Teratology oral (admix) in rats | 10% beadlet | 0, 250, 500, and 1000 | NOAEL, high dose | Teratology oral (gavage) in rabbits | Crystalline in oil | 0, 100, 200, and 400 | NOAEL, high dose | Two generations (admix) in rats | 10% beadlet | 0, 0, 50, 150, and 500 | NOAEL, high dose |
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