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EC number: 601-329-8
CAS number: 114798-26-4
The objective of the study was to characterise the potential toxicity of
DuP 753, resulting from daily oral administration.
DuP 753 administered in this study was well tolerated in the dog. There
were no toxicologically significant effects of treatment on body weight,
food consumption, clinical pathology, electrocardiography, physical
examinations, ophthalmoscopic examinations, or gross microscopic
post-mortem findings. A treatment-related increase in
the incidence of vomiting and fecal abnormalities was apparent in the
125 mg/kg/day dogs. These antemortem findings and
microscopic evidence of lymphocytic infiltration in the gastric mucosa
suggested a dose-related gastrointestinal irritation. There were
clinical signs suggestive of gastrointestinal irritation, increased
salivation and emesis in the 25 mg/kg group at slightly higher frequency
than the control group. There were no other effects in this group. Based
upon the results of this study, the maxium-tolerated-dosage (MTD) for
losartan potassium, and losartan free acid by read-across was >=125
mg/kg/day, the NOAEL 25 mg/kg/day and the NOEL was 5 mg/kg/day.
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