Lack of developmental toxicity of D-003: a mixture of long-chain fatty acids in rats

• Published in: Food and chemical toxicology 2003, Vol.41 (1), p.89-93
• Main Authors: Rodrı́guez, M.D, Gámez, R, González, J.E, Garcı́a, H, Acosta, C.P, Goicochea, E
• Format: Article
• Language: English
• Subjects: Abnormalities, Drug-Induced; Administration, Oral; adverse effects; animal models; Animals; bioactive properties; Biological and medical sciences; Body Weight - drug effects; Bone and Bones - abnormalities; Bone and Bones - drug effects; Cyclophosphamide - toxicity; developmental toxicity; Developmental toxicity in rats; dosage; dose response; Dose-Response Relationship, Drug; Embryonic and Fetal Development - drug effects; embryotoxicity; Fatty acids; Fatty Acids - toxicity; Female; Food toxicology; Male; Medical sciences; Mutagens - toxicity; No-Observed-Adverse-Effect Level; oral administration; organogenesis; Pregnancy; Pregnancy Rate; Random Allocation; Rats; Rats, Sprague-Dawley; reproductive efficiency; Sex Ratio; sugar products; teratogenicity; toxicity testing; Toxicology; waxes; Weight Gain - drug effects
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/S0278-6915(02)00217-X

D-003 is a mixture of long-chain fatty acids isolated and purified from sugar cane wax, the major component of which is 1-octacosanoic acid and which possesses effective antiplatelet, antithrombotic and cholesterol-lowering effects. D-003 was suspended in 1% acacia gum solution, and given daily by gavage to rats at dose levels of 5, 100 and 1000 mg/kg/day on days 6 through 15 of gestation. Cyclophosphamide, serving as a positive control, was given at the dose of 50 mg/kg/day on day 15 of gestation. Evidence of maternal or developmental toxicity was not observed in the groups treated with D-003. Maternal clinical signs of toxicity were not observed and the analysis of initial body weight and the body weight gain during the treatment period was comparable among the groups treated with D-003 and control. As expected, cyclophosphamide caused both embryotoxic and teratogenic effects in rats. Meanwhile, no adverse effects on reproductive performance, or on embryonic or fetal development, including visceral and skeletal examination, were seen in any of the groups administered D-003. It is concluded that D-003 administered up to 1000 mg/kg/day did not induce any evidence of developmental toxicity.