title: Safety assessment of Apoaequorin, a protein preparation: subchronic toxicity study in rats.
abstract: Apoaequorin, a calcium-binding protein originally isolated from jellyfish is available commercially as a dietary supplement. The objective of the present study was to investigate potential adverse effects, if any, of Apoaequorin, a recombinant protein preparation, in rats following subchronic administration. For this study, Sprague-Dawley (Hsd:SD) rats (10/sex/group) were administered via oral gavage 0 (control), 92.6, 462.9, and 926.0mg/kg body weight (bw)/day of Apoaequorin preparation, for 90 days. The corresponding amount of Apoaequorin protein was 0, 66.7, 333.3 and 666.7 mg/kg bw/day, respectively. Administration of the Apoaequorin preparation did not result in any mortality. There were no clinical or ophthalmological signs, body weight, body weight gain, food consumption, food efficiency, clinical pathology or histopathological changes attributable to administration of Apoaequorin. Any changes noted were incidental and in agreement with those historically observed in the age and strain of rats used in this study. Based on the results of this study, the No Observed-Adverse-Effect Level (NOAEL) for Apoaequorin was determined as 666.7 mg/kg bw/day, the highest dose tested.
authors.affiliation: Quincy Bioscience, 301 S. Westfield Road, Suite 200, Madison, WI 53717, USA.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Moran
authors.forename: Palma Ann
authors.initials: PA
authors.lastname: Marone
authors.forename: Mark R
authors.initials: MR
authors.lastname: Bauter
authors.forename: Madhu G
authors.initials: MG
authors.lastname: Soni
mesh_terms: D000284:Administration, Oral; D000331:Aequorin / Q000008:administration & dosage / Q000633:toxicity*; D000818:Animals; D001059:Apoproteins / Q000008:administration & dosage / Q000633:toxicity*; D001835:Body Weight / Q000187:drug effects; D019587:Dietary Supplements / Q000633:toxicity; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005123:Eye / Q000187:drug effects; D005260:Female; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D017207:Rats, Sprague-Dawley; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000633:toxicity; D059550:Toxicity Tests, Subchronic / Q000379:methods
chemical_list: D001059:Apoproteins; D011994:Recombinant Proteins; C060014:apoaequorin; D000331:Aequorin