Acute and subchronic (28-day) oral toxicity study in rats fed with novel surfactants
- 1 June 2004
- journal article
- Published by Springer Science and Business Media LLC in AAPS PharmSci
- Vol. 6 (2), 7-16
- https://doi.org/10.1208/ps060214
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
This publication has 7 references indexed in Scilit:
- Selective transfer of a lipophilic prodrug of 5-fluorodeoxyuridine from immunoliposomes to colon cancer cellsBiochimica et Biophysica Acta (BBA) - Biomembranes, 1999
- Controlled destabilization of a liposomal drug delivery system enhances mitoxantrone antitumor activityNature Biotechnology, 1999
- Poly(ethylene glycol)Published by American Chemical Society (ACS) ,1997
- Liposome circulation time and tumor targeting: implications for cancer chemotherapyAdvanced Drug Delivery Reviews, 1995
- Therapeutic effect of adriamycin encapsulated in long-circulating liposomes on meth-a-sarcoma-bearing miceInternational Journal of Cancer, 1994
- Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes.1994
- Liposomes disposition in vivo V. Liposome stability in plasma and implications for drug carrier functionBiochimica et Biophysica Acta (BBA) - General Subjects, 1982