Choice of vehicle for three-month continuous intravenous toxicology studies in the rat: 0.9% saline versus 5% glucose.
A study to assess the toxic potential of a candidate-drug administered to unrestrained rats as 1-h infusions thrice daily for 3 months, using 5% glucose as vehicle, had to be aborted on day 34 because of poor physical status and mortalities in all groups, including controls receiving the vehicle alone. Investigation demonstrated an opportunistic infection, probably secondary to the glucose present in the intravenous formulation. A second study using 0.9% saline solution as a vehicle, was successfully completed.
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Rhone-Poulenc Rorer SA, Drug Safety Department, Vitry, France.
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D000818:Animals; D001835:Body Weight / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D005260:Female; D005947:Glucose / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous / Q000662:veterinary; D008297:Male; D009894:Opportunistic Infections / Q000209:etiology / Q000662:veterinary*; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage* / Q000009:adverse effects; D051381:Rats; D017207:Rats, Sprague-Dawley; D012376:Rodent Diseases / Q000209:etiology*; D012965:Sodium Chloride / Q000008:administration & dosage* / Q000009:adverse effects; D013047:Specific Pathogen-Free Organisms; D018675:Toxicity Tests / Q000379:methods*; D014682:Vena Cava, Inferior / Q000382:microbiology / Q000473:pathology
D014677:Pharmaceutical Vehicles; D012965:Sodium Chloride; D005947:Glucose