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EC number: 822-547-1
CAS number: 906673-54-9
The objective of this study was to determine the potential toxicity of
PF-06932437, when given orally by gavage for 7daysto Wistar rats. In
addition,a No Observed Adverse Effect Level (NOAEL) was evaluated.
The following parameters and end points were evaluated in this study:
clinical signs, body weights, food consumption, clinical pathology
parameters (hematology, coagulation, clinical chemistry), gross necropsy
findings, organ weights, and histopathologic examinations. Test
item-related higher liver weights were observed in malesand
femalesstarting at 150 mg/kg, which correlated with microscopic
centrilobular hypertrophy in both sexes at 1000 mg/kg. Centrilobular
hypertrophy and the liver weight increase wasinterpreted as nonadverse
based on the low severity, absence of degeneration or necrosis and
absence of significant changed serum liver enzymes. Test item-related
higher adrenal and lower thymus weights were observed in females at 300
and 1000 mg/kg, which were considered non-adverse due to the lack of
histologic correlation and low magnitude of the change. Accumulation of
hyaline droplets was observed in the kidney of males at 1000 mg/kg.
This is a common spontaneous background change, however this wasnot
noted in the concurrent controls and treatment with the test item may be
associated with an increased incidence/severity of this change. The
increased kidney weights noted at males at 1000 mg/kg may correlate with
this histological finding. The accumulation of hyaline droplets and the
increased kidney weight were considered non-adverse based on the low
severity. No toxicologically significant changes were noted in any of
the remainingparameters investigated in this study(i.e.clinical
appearance, body weight, food consumption, clinical laboratory
investigationsand macroscopic examination). In conclusion,
administration of PF-06932437 by once daily oral gavage was well
tolerated in rats at levels of 1000 mg/kg. Based on these results, the
no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg.
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