title: Safety assessment of SDA soybean oil: results of a 28-day gavage study and a 90-day/one generation reproduction feeding study in rats.
abstract: Long chain polyunsaturated fatty acids (LC-PUFAs) in the diet reduce risk of cardiac mortality. Fish oils are a dietary source of LC-PUFAs (EPA, DHA) but intake is low in Western diets. Adding beneficial amounts of LC-PUFAs to foods is limited by their instability and potential to impart off-flavors. Stearidonic acid (SDA), a precursor of EPA in man, is more stable than EPA/DHA in food matrices. SDA is present in fish oils (0.5-4%) and in nutraceuticals (echium, borage oil). Genes for Delta6, Delta15 desaturases were introduced into soybeans that convert linoleic and alpha-linolenic acid to SDA (15-30% fatty acids). Since addition of SDA soybean oil into human foods increases SDA intake, toxicology studies were undertaken to assess its safety. In a 28-day pilot study, rats were gavaged with SDA soybean oil at dosages up to 3g/kg body weight/day; no treatment-related adverse effects were observed. A 90-day/one generation rat reproduction study was subsequently conducted where SDA soybean oil was added to diets to provide daily doses of 1.5 and 4 g/kg body weight. There were no treatment-related adverse effects on parental animals or on reproductive performance and progeny development.
authors.affiliation: Monsanto Company, 800 North Lindbergh Blvd., St Louis, MO 63167, USA. bruce.g.hammond@monsanto.com
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Hammond
authors.forename: Joan K
authors.initials: JK
authors.lastname: Lemen
authors.forename: Gulam
authors.initials: G
authors.lastname: Ahmed
authors.forename: Kathleen D
authors.initials: KD
authors.lastname: Miller
authors.forename: Jeannie
authors.initials: J
authors.lastname: Kirkpatrick
authors.forename: Tammye
authors.initials: T
authors.lastname: Fleeman
mesh_terms: D000704:Analysis of Variance; D000818:Animals; D001522:Behavior, Animal / Q000187:drug effects*; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000378:metabolism / Q000633:toxicity*; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D005333:Fetus / Q000187:drug effects; D005395:Fish Oils / Q000378:metabolism; D007441:Intubation, Gastrointestinal; D008098:Litter Size / Q000187:drug effects; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D010865:Pilot Projects; D011247:Pregnancy; D011897:Random Allocation; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects*; D012737:Sex Factors; D013024:Soybean Oil / Q000737:chemistry; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D018675:Toxicity Tests / Q000379:methods
chemical_list: D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D013024:Soybean Oil; C062895:stearidonic acid