A 13-week dietary toxicity study in rats of a Napin-Rich Canola Protein Isolate.

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.

A 13-week sub-chronic dietary toxicity study of a cruciferin-rich canola protein isolate in rats.

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.