Dietary lutein consumption is lower than the actual recommended allowances to prevent macular degeneration; thus dietary lutein supplements have been recommended. This study aimed to investigate potential adverse effect of lutein from Tagetes erecta in lutein-deficient (LD) male mice. Preliminary acute toxicity study revealed that the LD50 exceeded the highest dose of 10000 mg/kg BW. In a subacute study, male mice were gavaged with 0, 100, 1000 mg/kg BW/day for a period of 4 wk. Plasma lutein levels increased dose dependently (P < 0.01) after acute and subacute feeding of lutein in LD mice. Compared to the control (peanut oil without lutein) group, no treatment-related toxicologically significant effects of lutein were prominent in clinical observation, ophthalmic examinations, body, and organ weights. Further, no toxicologically significant findings were eminent in hematological, histopathological, and other clinical chemistry parameters. In the oral subacute toxicity study, the no-observed-adverse-effect level (NOAEL) for lutein in LD mice was determined as 1000 mg/kg/day, the highest dose tested.
This study showed no treatment-related toxicologically significant effects when male LD mice gavaged excessive lutein of around 1000 mg/kg BW for 4 wk. Although aspartate amino transferase and alanine amino transferase showed statistically significant increase and red blood cell count showed a significant reduction in the 1000 mg/kg BW group, the deviations observed among the groups were within the normal laboratory ranges and were not supported by other changes in clinical, hematological parameters and histopathological observations. Lutein up to 1000 mg/kg BW showed no adverse effects in male LD mice, similar to those reported in healthy rodent or mammalian models.