A subchronic toxicity study of dunaliella carotene in F344 rats.
Dunaliella carotene, extracted from dunaliella alga (Dunaliella bardawil or Dunaliella salina), for use as a food-coloring agent, has beta-carotene as its mainly constituent. As there have been no reports of toxicological evaluation, a 90-day subchronic toxicity study was here performed in F344 rats at dose levels of 0 (control), 0.63%, 1.25%, 2.5% and 5% in powdered basal diet. The average daily intakes of dunaliella carotene were 352, 696, 1420 and 2750 mg/kg/day, respectively, for males, and 370, 748, 1444 and 2879 mg/kg/day for females. No mortality or treatment-related clinical signs were observed throughout the experimental period in any of the groups. Body weight gain was slightly but significantly (p < 0.05) reduced from week 5 to the end of the experiment in 2.5% and 5% males. Increased PLT were observed in 1.25% and 5% males, and 2.5% and 5% females. Significant elevations or tendencies for increase in serum T. Cho and Ca were observed in all treated males and females, with clear dose-dependence in males. Organ weight measurement and histopathological observation revealed no toxicological changes. Based on growth suppression, no-observed-adverse-effect-levels (NOAELs) were estimated to be 1.25% (696 mg/kg/day) for males and 5% (2879 mg/kg/day) for females. As increases in serum Ca were observed in the lowest group in both sexes, a no-observed-effect level (NOEL) could not be determined in this study.
Kuroiwa
Y
Y
Division of Pathology, National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.
Nishikawa
A
A
Imazawa
T
T
Kitamura
Y
Y
Kanki
K
K
Ishii
Y
Y
Umemura
T
T
Hirose
M
M
D000284:Administration, Oral; D000818:Animals; D001792:Blood Platelets / Q000187:drug effects; D002118:Calcium / Q000097:blood; D000460:Chlorophyta / Q000737:chemistry*; D002784:Cholesterol / Q000097:blood; D004305:Dose-Response Relationship, Drug; D005260:Female; D005505:Food Coloring Agents / Q000032:analysis / Q000633:toxicity*; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D010936:Plant Extracts / Q000032:analysis / Q000633:toxicity; D010976:Platelet Count; D051381:Rats; D011916:Rats, Inbred F344; D018675:Toxicity Tests; D015430:Weight Gain / Q000187:drug effects; D019207:beta Carotene / Q000032:analysis / Q000633:toxicity*
D005505:Food Coloring Agents; D010936:Plant Extracts; D019207:beta Carotene; D002784:Cholesterol; D002118:Calcium