title: A 13-week sub-chronic dietary toxicity study of a cruciferin-rich canola protein isolate in rats.
abstract: The objective was to evaluate the safety of a cruciferin-rich canola protein isolate (Puratein) when fed as a protein source at various dietary levels to rats 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-93 G based protein-free diet added respectively with 5%, 10% and 20% (w/w) Puratein (test article) or 20% (w/w) vitamin-free casein (control article). Protein levels were adjusted in all groups at 18% using vitamin-free casein. Body weights, food consumption, locomotor activity and behavioral and clinical pathology parameters were recorded at various points of the study, followed by macroscopic examination, determination of organ weights and microscopic tissue examination. There were no test article-related effects on body weight, food consumption, clinical observations, functional observational battery, motor activity, clinical pathology, or ophthalmic examinations. A slightly higher thyroid/parathyroid weight (g/100g BW) noted in the 20% Puratein group was not correlated with histopathological changes. The no-observed-effect-level (NOEL) was 10%, whereas the no-observed-adverse-effect-level (NOAEL) was the highest fed level of 20%, equivalent to 11.24 g/kg BW/day for males and 14.11 g/kg BW/day for females. The cruciferin-rich canola protein isolate (Puratein) was considered safe under the conditions tested.
authors: Archer Daniels Midland Company, Decatur, IL 62521-1656, USA. mejia@adm.com
authors: Luis A
authors: LA
authors: Mejia
authors: Chandrashekhar K
authors: CK
authors: Korgaonkar
authors: Martin
authors: M
authors: Schweizer
authors: Christopher
authors: C
authors: Chengelis
authors: Gary
authors: G
authors: Marit
authors: Ellen
authors: E
authors: Ziemer
authors: Richard
authors: R
authors: Grabiel
authors: Mark
authors: M
authors: Empie
mesh_terms: D000821:Animal Feed; D000818:Animals; D052179:Antigens, Plant / Q000032:analysis / Q000633:toxicity*; D001522:Behavior, Animal / Q000187:drug effects; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D029688:Brassica napus / Q000737:chemistry*; D004032:Diet; D004435:Eating / Q000187:drug effects; D005260:Female; D006403:Hematologic Tests; D008136:Longevity / Q000187:drug effects; D008297:Male; D009043:Motor Activity / Q000187:drug effects; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D010280:Parathyroid Glands / Q000187:drug effects / Q000473:pathology; D051381:Rats; D017207:Rats, Sprague-Dawley; D055314:Seed Storage Proteins / Q000032:analysis / Q000633:toxicity*; D013961:Thyroid Gland / Q000187:drug effects / Q000473:pathology; D018675:Toxicity Tests / Q000379:methods; D016482:Urinalysis
chemical_list: D052179:Antigens, Plant; D055314:Seed Storage Proteins; C059777:cruciferin protein, Brassica napus