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AAPS PharmSci. Jun 2004; 6(2): 7–16.
Published online Apr 7, 2004. doi:  10.1208/ps060214
PMCID: PMC2751006
Acute and subchronic (28-day) oral toxicity study in rats fed with novel surfactants
Ranjit Madhukar Bidhe1 and Sangita Ghoshcorresponding author2
1Indian Institute of Toxicology, KIM 2057, Sadashiv Peth, Vijaynagar Colony, 411 030 Pune, India
2BioZone Laboratories Inc, 94565 Pittsburg, CA
Sangita Ghosh, Phone: (925) 473-1000, Fax: (925) 473-1001, sghosh/at/biozonelabs.com.
corresponding authorCorresponding author.
Received July 8, 2003; Accepted November 17, 2003.
Abstract
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.
KeyWords: oral toxicity, rats, polyoxyethylene glycol (PEG), liposomes
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American Association of Pharmaceutical Scientists