title: Developmental and reproductive toxicological evaluation of arachidonic acid (ARA)-Rich oil and docosahexaenoic acid (DHA)-Rich oil.
abstract: The purpose of this study was to investigate the reproductive and developmental toxicity of dietary exposure to DHA-rich oil from Schizochytrium sp. and ARA-rich oil from Mortierella alpina. In a developmental toxicity study, pregnant Wistar rats were untreated (control) or administered corn oil (vehicle control), 1000, 2500, or 5000 mg/kg bw/day of DHA-rich oil or ARA-rich oil via gavage from gestation days 6 through 20. In the reproductive toxicity study, male and female Wistar rats were administered vehicle control (corn oil), or 1000, 2500, or 5000 mg/kg bw/day of DHA- or ARA-rich oil via gavage throughout the mating period, pregnancy, and the nursing and lactation period. Differences in the number of fetuses, fetal skeletal malformations, and external and visceral anomalies in the developmental study and mortality, clinical signs, fertility indices, physical observations, gross necropsy findings, and gestation period length in the reproductive toxicity study were not dose-related or significantly different from control groups, and were not considered to be treatment related. The no observed adverse effect level (NOAEL) for maternal toxicity and embryo/fetal development and for paternal or maternal treatment-related reproductive toxicity for the DHA-rich oil and ARA-rich oil administered by gavage, was 5000 mg/kg bw/day.
authors.affiliation: LSRO Solutions LLC, 2286 Dunster Lane, Rockville, MD 20854, United States. Electronic address: falkm@lsro.org.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Falk
authors.affiliation: Runke Bioengineering (Fujian) Co., Ltd, Zhao'an County, Zhangzhou City, Fujian Province, China.
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Zheng
authors.affiliation: Runke Bioengineering (Fujian) Co., Ltd, Zhao'an County, Zhangzhou City, Fujian Province, China.
authors.forename: Dieling
authors.initials: D
authors.lastname: Chen
authors.affiliation: Runke Bioengineering (Fujian) Co., Ltd, Zhao'an County, Zhangzhou City, Fujian Province, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: Runke Bioengineering (Fujian) Co., Ltd, Zhao'an County, Zhangzhou City, Fujian Province, China.
authors.forename: Zeshen
authors.initials: Z
authors.lastname: Liu
authors.affiliation: LSRO Solutions LLC, 2286 Dunster Lane, Rockville, MD 20854, United States.
authors.forename: Kara D
authors.initials: KD
authors.lastname: Lewis
mesh_terms: D000818:Animals; D016718:Arachidonic Acid / Q000633:toxicity*; D001835:Body Weight / Q000187:drug effects; D004281:Docosahexaenoic Acids / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D005260:Female; D007044:Hysterectomy; D008297:Male; D020094:Mortierella / Q000737:chemistry; D009821:Oils / Q000737:chemistry / Q000633:toxicity*; D011247:Pregnancy; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects*; D058009:Stramenopiles / Q000737:chemistry; D015996:Survival Rate; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D009821:Oils; D004281:Docosahexaenoic Acids; D016718:Arachidonic Acid
keywords: Arachidonic acid; Developmental; Docosahexaenoic acid; Mortierella alpina; Reproductive; Schizochytrium sp.; Toxicity