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EC number: 211-185-4
CAS number: 632-79-1
After treatment for 28 days, bromine levels
measured in skin (50, 500 mg/kg/d) and blood (500 mg/kg/d) were
statististically significantly higher when compared to the control
group. In skin, mean measured bromine levels in the control, 50 and 500
mg/kg/d groups were 39.6, 712.0 and 726.5 ppm, respectively. Similarly,
mean measured bromine levels in blood were 8.7, 10.0 and 13.3 ppm. No
statistical differences were observed between the control and 50 or 500
mg/kg/d groups in bromine levels measured in the liver, fat or kidney.
For the purposes of statistical comparison, meausrements from male and
female rabbits in each dose group were combined (n=6/group).
The test article was applied dermally at 0,
50, 500 or 5000 mg/kg/d, 5 days/week for 4 weeks. Three male and three
female rabbits were used at each dose level. The control rabbits were
treated with saline only at a volume of 12 ml on the same regimen as
treated animals. The rabbits were observed daily for changes in general
behavior and apppearance. Observations for dermal irritation were done
prior to and following the 6 hr test article administration period.
Individual body weights were recorded weekly. Once in the control group
and on study day 14 and 26, blood and urine samples were collected from
all rabbits. All rabbits were sacrificed following 28 d of treatment.
Selected tissues (approximately 28) in the control and 500 mg/kg/d
groups were examined by histopathology (paraffin embeddded, sectioned,
stained with hematoxylin and eosin). Skin, liver, kidney and bone
marrow from the 50 mg/kg/d group were also examined histologically. All
rabbits were sacrificed following 28 d of treatment. Selected tissues
(approximately 28) in the control and 500 mg/kg/d groups were examined
by histopathology (paraffin embeddded, sectioned, stained with
hematoxylin and eosin). Skin, liver, kidney and bone marrow from the 50
mg/kg/d group were also examined histologically.
Very slight to slight and occasionally
moderate erythema was noted in control rabbits and in rabbits at the 50
mg/kg/d dose. Very slight to moderate erythema was noted for rabbits at
the 500 and 5000 mg/kg/d doses. Moderate desquamation was noted for 3 of
the rabbits at the 5000 mg/kg/d dose.
One rabbit at the 5000 mg/kg/d dose showed
marked ataxia, unable to lift head or right itself and dyspnea and was
sacrificed in extremis. All of the rabbits at the 5000 mg/kg/d dose died
or were sacrificed in extremis between days 10 and 26 of the study. Body
weights were similar in control, 50 and 500 mg/kg/d groups. Rabbits at
the 5000 mg/kg/d dose lost weight prior to death. Organ weights among
groups appeared comparable. At day 14, 1 rabbit in the high dose group
had a moderate increase in BUN. At day 26, the hematology, serum
chemistry and urinalysis results in the one surviving rabbit at the high
dose were: neutrophilia with lymphopenia, nucleated erythrocytes, marked
increase in glucose and BUN, and albumin in the urine.
Deaths or declining condition necessitating
early sacrifice of all rabbits at the high dose were considered
compound-related. At necropsy, several rabbits in the high dose group
had pale livers, accentuated liver lobulation and gastric irritation.
These effects observed at necropsy may have been compound-related. No
gross lesions were observed in the low and mid-dose groups.
Microscopically, the only lesion seen in animals in the low and mid-dose
groups considered compound related was a very slight hyperkeratosis of
the application site in one rabbit in the mid-dose group.
The NOEL for mortality was 500 mg/kg/d. The
NOAEL for systemic toxicity was 500 mg/kg/d.
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