title: A 13-week dietary toxicity study in rats of a Napin-Rich Canola Protein Isolate.
abstract: The objective was to study the safety of a Napin-Rich Canola Protein Isolate (NRCPI) fed to rats at various levels for 13-weeks. The study included four groups (20 animals/sex/group) of young Sprague Dawley rats. They were fed ad libitum with an AIN-93G based protein-free diet containing, respectively, 5%, 10% and 20% (w/w) NRCPI (test article) or 20% (w/w) vitamin-free casein (control article). Protein levels were adjusted at 18% in all groups with vitamin-free casein. Body weights, food consumption, locomotor activity and behavioral and clinical pathology parameters were recorded at various points in the study, followed by macroscopic examination, determination of organ weights and microscopic examination at termination. There were no test article-related effects on ophthalmology, functional observations, hematology, serum chemistry, urinalysis, organ weights and macroscopic or microscopic findings. Lower body weight gains were observed in the 10% NRCPI-treated males and the 20% NRCPI-treated males and females. The lower body weight gains were associated with significantly lower food consumption. Therefore, for NRCPI the No Observed Adversed Effect Level (NOAEL) was considered to be 20% (the highest fed level); equivalent to 12.46 g/kg BW/day for males and 14.95 g/kg BW/day for females. The NRCPI was considered safe under the tested conditions.
authors.affiliation: Archer Daniels Midland Company, Decatur, IL 62521-1656, USA. mejia@adm.com
authors.forename: Luis A
authors.initials: LA
authors.lastname: Mejia
authors.forename: Chandrashekhar K
authors.initials: CK
authors.lastname: Korgaonkar
authors.forename: Martin
authors.initials: M
authors.lastname: Schweizer
authors.forename: Christopher
authors.initials: C
authors.lastname: Chengelis
authors.forename: Meliton
authors.initials: M
authors.lastname: Novilla
authors.forename: Ellen
authors.initials: E
authors.lastname: Ziemer
authors.forename: Patricia S
authors.initials: PS
authors.lastname: Williamson-Hughes
authors.forename: Richard
authors.initials: R
authors.lastname: Grabiel
authors.forename: Mark
authors.initials: M
authors.lastname: Empie
mesh_terms: D055516:2S Albumins, Plant / Q000633:toxicity*; D000818:Animals; D001522:Behavior, Animal / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects*; D029688:Brassica napus / Q000737:chemistry*; D004435:Eating / Q000187:drug effects; D005260:Female; D008297:Male; D009043:Motor Activity / Q000187:drug effects; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests
chemical_list: D055516:2S Albumins, Plant; C050363:napin protein, Brassica napus