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EC number: 680-378-7
CAS number: 138624-11-0
1. Mortality, Physical Signs, Body Weight, and Food Consumption
All dogs survived to the termination of the experiment. There were no
treatment-related physical signs. Emesis was seen in some drug-treated
during the recovery from anesthesia. This was not considered related to
treatment. There were no drug-related effects on body weight or food
2. Gross and Light Microscopic Changes
There were no drug-related gross or light microscopic changes in the
of dogs exposed weekly to the oral buffered formulation of alendronate
a concentration of 3.73 mg/mL. In contrast, there was gross and/or
evidence of esophageal irritation in dogs infused at the highest
(7.47 mg/mL); at necropsy, in 2 dogs, there was focal reddening of the
esophageal mucosa and histologically there was very slight to moderate
esophagitis (erosive or ulcerative) in all dogs.
This study has demonstrated that the oral buffered formulation of
alendronate sodium, at a concentration of 3.73 mg/mL, is not irritating
to the esophageal mucosa in dogs. At the highest concentration (7.47
mg/mL) studied, there was gross and light microscopic evidence of
esophageal irritation in dogs after weekly exposure for 4 weeks.
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