A 91-day feeding study in rats with caprenin.
Caprenin, a randomized triglyceride primarily comprising caprylic (C8:0), capric (C10:0), and behenic (C22:0) acids, was administered in a semi-purified diet to weanling Sprague-Dawley rats (25/sex/group) at dose levels of 5.23, 10.23 or 15.00% (w/w) for 91 days. Corn oil was added at 8.96, 5.91 and 3.00%, respectively, to provide essential fatty acids and digestible fat calories. Corn oil alone (12.14%) and a blend of medium-chain triglyceride (MCT) oil plus corn oil (11.21 and 3.13%, respectively) served as controls. All diets were formulated to provide about 4000 kcal/kg of diet and 26.8% of digestible calories from fat by assuming that corn oil, MCT oil, and caprenin provided 9, 7 and 5 kcal/g, respectively. Survival, clinical signs, body weight, feed consumption, feed efficiency, organ weights, organ-to-body-weight ratios, organ-to-brain-weight ratios, haematological values and clinical chemistry parameters were evaluated in all groups. Histopathology of a full complement of tissues was evaluated in the corn oil and MCT oil control groups as well as the high-dose caprenin group. Additional rats (n = 5/sex/group) were included in the study to determine whether there was marked storage of C22:0 in heart, liver or perirenal fat at the end of the 91-day feeding period. No significant differences in body weight gain were measured with the balanced caloric diets, although feed conversion efficiency was reduced in the high-dose caprenin group. No adverse effects from the ingestion of caprenin were detected, nor were significant amounts of C22:0 present in the fat extracted from the selected fat depot sites. These results establish a no-observable-adverse-effect level (NOAEL) of more than 15% (w/w) caprenin in the diet (or more than 83% of total dietary fat), which is equal to a mean exposure level of more than 13.2 g/kg/day for male rats and more than 14.6 g/kg/day for female rats.
Webb
D R
DR
Procter & Gamble Company, Cincinnati, OH 45224-1703.
Wood
F E
FE
Bertram
T A
TA
Fortier
N E
NE
D000273:Adipose Tissue / Q000737:chemistry; D000284:Administration, Oral; D000821:Animal Feed; D000818:Animals; D001774:Blood Chemical Analysis; D002210:Caprylates / Q000633:toxicity*; D003106:Colon / Q000187:drug effects; D003314:Corn Oil / Q000008:administration & dosage; D003652:Decanoic Acids / Q000633:toxicity*; D004041:Dietary Fats / Q000008:administration & dosage / Q000633:toxicity*; D004355:Drug Stability; D004435:Eating / Q000187:drug effects; D004909:Erythrocyte Indices; D005227:Fatty Acids / Q000032:analysis / Q000633:toxicity*; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D007668:Kidney / Q000187:drug effects / Q000473:pathology; D008099:Liver / Q000187:drug effects; D008297:Male; D009929:Organ Size / Q000187:drug effects; D011897:Random Allocation; D051381:Rats; D017207:Rats, Sprague-Dawley; D014280:Triglycerides / Q000008:administration & dosage / Q000633:toxicity*; D015430:Weight Gain / Q000187:drug effects
D002210:Caprylates; D003652:Decanoic Acids; D004041:Dietary Fats; D005227:Fatty Acids; D006454:Hemoglobins; D014280:Triglycerides; C085281:caprenin; D003314:Corn Oil; C007547:behenic acid