Subchronic (13-week) toxicity and prenatal developmental toxicity studies of dietary astaxanthin in rats.
Two studies examined the effects of dietary astaxanthin on Hanlbm Wistar (SPF) rats. Male and female rats receiving astaxanthin concentrations up to 1.52% of the feed for 13 weeks showed no evidence of toxicity; no effects were noted in the offspring of female rats exposed to astaxanthin at up to 1.39% of the feed during the period of organogenesis (GD 7-16). Discoloration of the feces and yellow pigmentation of adipose tissue was seen in the 13-week study, an intrinsic property of the substance, and not a sign of toxicity. Differences between the control and astaxanthin groups, some of which reached statistical significance, were generally sporadic (i.e., transient and/or not related to astaxanthin concentration) and not considered of biological or toxicological significance. Blood cholesterol levels, for example, were greater in animals receiving astaxanthin for 13 weeks, but remained within the normal range. The highest dietary concentration of astaxanthin in each of the studies is proposed as a no-observable-adverse-effect level (NOAEL). Specifically, 1.52% for the 13-week study, corresponding to a mean intake of 1033 mg/kg bw/day (range: 880-1240 mg/kg bw/day), and 1.39% for the developmental toxicity study, corresponding to a mean intake of approximately 830 mg/kg bw/day (range: 457-957 mg/kg bw/day).
Intertek Scientific & Regulatory Consultancy, 100 Davidson Ave., Somerset, NJ, USA.
Katherine
K
Vega
NIC-RD/HN Toxicology and Kinetics, DSM Nutritional Products Ltd, Wurmisweg 576, 4303 Kaiseraugst, Switzerland. Electronic address: james-a.edwards@dsm.com.
James
J
Edwards
NIC-RD/HN Toxicology and Kinetics, DSM Nutritional Products Ltd, Wurmisweg 576, 4303 Kaiseraugst, Switzerland.
Paul
P
Beilstein
D000821:Animal Feed / Q000633:toxicity*; D000818:Animals; D015415:Biomarkers / Q000097:blood; D004032:Diet / Q000009:adverse effects*; D005260:Female; D005333:Fetus / Q000187:drug effects*; D005865:Gestational Age; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D038081:Organogenesis; D011247:Pregnancy; D017208:Rats, Wistar; D018570:Risk Assessment; D013997:Time Factors; D059550:Toxicity Tests, Subchronic; D024341:Xanthophylls / Q000008:administration & dosage / Q000633:toxicity
D015415:Biomarkers; D024341:Xanthophylls; C005948:astaxanthine
Astaxanthin; Developmental toxicity; Diet; Oral toxicity; Rat; Reproduction; Safety