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EC number: 907-672-2
CAS number: -
To evaluate the subchronic toxicity of DBPP, Sprague-Dawley rats were
exposed daily to diets containing target dose levels of 5, 50 and 250 mg
of DBPP per kilogram of body weight for 91 days. Survival, clinical
signs, body weights, food consumption values, ophthalmoscopic
examination results, clinical pathology data, terminal body weights,
absolute and relative organ weights and gross and microscopic pathology
were evaluated for compound effects.
At 250 mg/kg, the high-dose level, dietary exposure to DBPP resulted in
derpessed weekly body weights and/or growth rates, as well as decreased
weekly food consumption in males and females and significantly lower
total food consumption in female rats. Inhibition of plasma, erythrocyte
and brain cholinesterase levels (females only for the brain
cholinesterase) was determined in this group of rats, with depression of
the plasma cholinesterase being most pronounced. Hematology effects
noted included depressed erythrocyte counts, hematocrits and hemoglobin
levels, as well as some slight changes in erythrocyte morphology. Total
cholesterol was increased in males only. Decreased terminal body weights
and increased absolute and relative liver weights were also noted as
treatment effects. Histopathologic changes were seen in the liver and
urinary bladder of males and females exposed to DBPP at this level.
Because the initial histopathology evaluation did not establish a
no-effect level with regard to changes in the urinary bladder, a second
pathologist reviewed the bladder slides without prior knowledge of
treatment or of the original pathologist's findings. There was a
consensus by both pathologists, and a conclustion by the coordinating
pathologist, that treatment related epithelial hyperplasia and
submucosal inflammation were present in the bladders of males and
females of the high-dose group. The liver findings were characterized by
decreased hepatocytic vacuolization in males and increased fatty change
in males and females. These liver findings are considered of
questionnable biological significance.
At 50 mg/kg, the mid-dose level, some depression of weekly body weights
and total food consumption was noted. Plasma cholinesterase levels were
inhibited in female rats only. The histomorphological changes in the
urinary bladder of epithelial hyperplasia and submucosal inflammation
were considered treatment effects in males at this level. The
coordinating pathologist drew the conclusion that in females the
incidence and severity of these bladder changes were not sufficient to
substantiate a treatment effect. Hepatocytic vacuolization in the liver
was observed in males, but again was of questionnable biological
No effects of exposure to DBPP were seen at the 5 mg/kg level. The
review of urinary bladders on a blind basis established no clear
difference in incidence or severity of urinary bladder findings between
this low-dose group and controls.
In conclusion, treatment-related effects on body weights, food
consumption, clinical pathology results, organ weights and
histopathology results were seen in males and females exposed at 250
mg/kg. Treatment-effects on body weights, food consumption, clinical
pathology results (females) and histopathology results (males) were
observed at 50 mg/kg. There were no treatment-related effects at the 5
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