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International Research and Development Corporation
Page 1
I.
SYNOPSIS
In a 90-day oral toxicity study ^———ttwas fed 7 days each week
to male and female beagle dogs at dietary levels of 100, 500 or 2500
ppm. After 35 days of feeding, the 500 ppm. and 2500 ppm. dietary
levels were increased to 1000 ppm. and 5000 ppm., respectively for
the duration of the 90 days of treatment.
No pharmacodynamic and/or gross toxic signs were observed.
Detailed physical examination revealed all dogs to be essentially
normal.
No adverse body weight changes occurred among any dogs used for
this study.
Food consumption values remained relatively constant,
and average daily water intake and urine output were not meaningfully
different from values obtained in the control period.
No alterations in hematologic parameters were observed which
could be related to feeding the test compound.
No biologically meaningful changes occurred with respect to plasma
glucose, protein, albumin, urea nitrogen or albumin-to-globulin ratios.
A
biologically significant increase in plasma cholesterol was
found for 5-of-6 dogs at the 2500 ppm.
dietary level.
Prothrombin time determinations and serum glutamic pyruvic transaminase
(SGPT) and serum glutamic oxalacetic transaminase (SGOT)
B
activities remained within the usual ranges at all periods of measure¬
ment.
Alkaline phosphatase activities exhibited an upward trend in
2
of 6 dogs at the high dietary level.
Urinalysis did not reveal compound-related changes at any period
of examination.
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