Article

AAPS PharmSci

, Volume 6, Issue 2, pp 7-16

First online:

Acute and subchronic (28-day) oral toxicity study in rats fed with novel surfactants

  • Ranjit Madhukar BidheAffiliated withIndian Institute of Toxicology
  • , Sangita GhoshAffiliated withBioZone Laboratories Inc Email author 

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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