title: Reproduction studies in the rat with shea oleine and hardened shea oleine.
abstract: Shea oleine is an oil fraction derived from the nut of the tree Butyrospermum parkii, which grows in central and western Africa. There are several uses of shea oleine including its use as a frying oil and, after hardening, in margarine and toffee fat. This investigation was performed to examine the toxicity of 7 or 15% hardened shea oleine in comparison with 7 or 15% unhardened shea oleine and various commercially available materials, sheanut and palm oils, cocoa butter and toffee powder following dietary administration to rats during pre-mating, mating, pregnancy and offspring weaning in two separate investigations. Reproduction was assessed using number of litters and pups born plus survival and body weights at birth and at weaning on day 21. Skeletal evaluation using X-ray, clinical pathology and a macroscopic examination were also performed for F1 rats. Study measures for parent animals comprised evaluation of body weight, food consumption, clinical pathology, organ weights and macroscopic examination. Fatty acids and hydrocarbon levels were measured and an evaluation for lipogranulomata was made for various tissues. Results showed that shea oleine, whether unhardened or hardened, produced no evidence of reproduction toxicity and gave a similar profile to the other commercially available materials used in this study in the rat. Minor findings with shea oleine were not related to reproduction performance but comprised slightly reduced body weight gain and reduced cholesterol and raised alkaline phosphatase levels. None of the findings in this study were considered to be of toxicological significance. Thus, no evidence of reproduction toxicity was seen for both unhardened and hardened shea oleine in this investigation in the rat at levels equating to greater than 7.5 g/kg/day.
authors.affiliation: Consultancy & Regulatory Services, Covance Laboratories Ltd, Otley Road, North Yorkshire HG3 1PY, Harrogate, UK.
authors.forename: P
authors.initials: P
authors.lastname: Baldrick
authors.forename: J A
authors.initials: JA
authors.lastname: Robinson
authors.forename: P A
authors.initials: PA
authors.lastname: Hepburn
mesh_terms: D000469:Alkaline Phosphatase / Q000097:blood; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D004041:Dietary Fats / Q000633:toxicity; D004435:Eating; D005260:Female; D008098:Litter Size / Q000187:drug effects; D008297:Male; D009754:Nuts / Q000737:chemistry*; D009829:Oleic Acids / Q000633:toxicity*; D009929:Organ Size / Q000187:drug effects; D000073878:Palm Oil; D010938:Plant Oils / Q000737:chemistry / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects*; D013534:Survival; D014197:Trees / Q000737:chemistry*
chemical_list: D004041:Dietary Fats; D009829:Oleic Acids; D010938:Plant Oils; C434349:shea oleine; C052387:cocoa butter; D000073878:Palm Oil; D002784:Cholesterol; D000469:Alkaline Phosphatase