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EC number: 203-052-4
CAS number: 102-77-2
No compound related signs were noted for any animal in the test group
during the study.
A number of incidental and spontaneous signs were noted for a few
rabbits in the control and test groups. These observations included:
clear and purulent nasal discharge, clear and purulent ocular doscharge,
no stool in pan, soft stool, diarrhea, mucoid diarrhea, yellow mucoid
diarrhea, possible anorexia and emaciation. One male of the 125 mg/kg
bw/d group exhibited possible anorexia, hyperactivity and soft stool
prior to being found dead. One female of the 500 mg/kg bw/d group
appeard normal prior to death. One male of the 2000 mg/kg bw/d group was
noted as having possible anorexia, no stool in pan, and was emaciated
prior to death. One female of the control group, exhibited possible
anorexia, emaciation, mucoid diarrhea, purulent ocular discharge,
prostration, hypothermia, bradypnea, ataxia and hypoactivity prior to
being sacrificed. There were no remarkable differences in the incidence
of animals exhibiting anorexia among the control and test groups.
No treatment related death was noted, 1/5 male 125 mg/kg bw/d (abraded
skin) was found dead on study day 10; 1/5 female of the 500 mg/kg bw/d
group 8intact skin) was found dead on day 14 and 1/5 male of the 2000
mg/kg bw/d group (intact skin) was found dead on study day 8.
The majority of the rabbits in both the control and test groups (abraded
and intact skin) exhibited no dermal irritation during the study period
except for a frw rabbits in the control group which exhibited very
slight desquamation. Some rabbits also exhibited red raised areas on the
shaved back. In the three test articel groups 125, 500 and 2000 mg/kg
bw/d, a few rabbits exhibited very slight to slight erythema, edema and
desquamation during the study period. No eschar or exfoliation was
observed in any group.
No statistically significant differences were seen in group mean body
Clinical laboratory tests
Sight decreases in hematocrit, hemoglobin and total erythrocytes were
seen for females at 2000 mg/kg bw/d.Although the means of these values
for the females receiving 2000 mg/kg bw/d were statistically significant
lower (p<0.05) than the mean of the control females the actual
differences were slight. In the absence of any changes for males
reveiving 2000 mg/kg bw/d it was considered that this decrease in
hematologic parameters for females receiving 2000 mg/kg bw/d was not
related to the test substance.
Lactic dehydrogenase (LDH) activity was lower and cholesterol values
werehigher for males at 2000 mg/kg bw/d when compared to control.
Cholesterol values also were higher for males at 500 mg/kg bw/d. These
differences were not statistically significant, and because of the wide
range of these values, the authors considered these differences (LDH and
cholesterol) as not related to the test substance.
Incidental findings included a decreased potassium level for one male at
500 mg/kg bw/d and moderate to market increases in creatinine and blood
urea nitrogen levels and decrease in serum calcium for one female at
2000 mg/kg bw/d.
The skin from the application site was mostly unremarkable, three
animals of the 500 mg/kg bw/d group and two of the 2000 mg/kg bw/d group
presented prominent vessels or pinpoint hemoohagic areas subcutaneously.
The systemic observations were mainly in the lung, they were interpreted
as congestion or pneumonic areas mainly. The contents of the
gastrointestinal tract were decribed as watery in control and treated
Body and organ weights:
The body weight means of males and females of the control and treated
groups were simular. most of the absolute and relative organ weights
were within the usual range. Only relative weight mean of testes from
the 125 mg/kg bw/d group were increased. The author stated that the
biological significance of this increase is unknown.
The skin from the site of application of the males presented mainly
hyperkeratosis, acanthosis, and infiltration of inflammatory cells in
the dermis. The incudence and severity of the lesions appears to be
greater in the control and low dose groups than in the higher dose
groups. Simular findings were noted for the site of application of the
females. The skin from the untreated site presented simular lesions.
The other organs presented cases of pneumonia, nephritis and some other
lesions which were considered unrelated to the application of the test
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