Acute and subchronic (28-day) oral toxicity study in rats fed with novel surfactants
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The toxicity of 2 new synthetic lipids, 1,2-dioleoyl-rac-glycerol-3-dodecaethylene glycol, GDO-12 (lipid 1) and 1,2-distearoyl-rac-glycerol-3-dodecaethylene glycol, GDS-12 (lipid 2) has been evaluated in acute and subchronic toxicity studies. Acute oral toxicity studies in male and female rats documented no deaths or treatment-related signs at high doses. The lipids were individually administered (by gavage) to male and female Sprague-Dawley rats at concentrations of 250, 500, and 1000 mg/Kg bodyweight for 28 days. All animals survived the duration of the study, with no significant changes in clinical signs, hematological parameters, organ weights, ophthalmology evaluations, or histopathological findings. These studies establish that both GDO-12 (lipid 1) and GDS-12 (lipid 2) are nontoxic in rats following oral administration. The no-observed-adverse-effect level ranged between 250 mg/Kg and 1000 mg/Kg following oral administration.
KeyWordsoral toxicity rats polyoxyethylene glycol (PEG) liposomes
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- 1.Lasic DD. Liposomes: From Physics to Applications. Oxford, UK: Elsevier Science Ltd; 1993.Google Scholar
- 8.Food and Agriculture Organization (FAO). Principles for the Safety Assessment of Food Additives and Contaminant in Food International Programme on Chemical Safety (IPCS) in co-operation with the project FAO/WHO expert committee on food additives (JECFA). Rome, Italy: Food and Agriculture Organization; 1987. Environmental Health Criteria 70.Google Scholar
- 9.Dacie VJ, Lewis SM. Practical Haematology. International student ed. Oxford, UK: Churchill Livingstone; 1984.Google Scholar
- 10.Brij MM, Rawnsley HM. Clinical, Biochemical and Hematological Reference Values in Normal Experimental Animals. Masson: New York; 1977.Google Scholar
- 12.Lasic DD, Martin FJ. Stealth Liposomes. Boca Raton: CRC Press; 1995.Google Scholar
- 13.Keller BC, Lasic DD. Self-forming, thermodynamically stable liposomes and their applications. US patent 6 610 322, August 26, 2003.Google Scholar