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EC number: 609-946-4
CAS number: 41637-38-1
The objective of this study was to evaluate the potential toxicity
of the test item,Ethoxylated (3) bisphenol A dimethacrylate, following
daily oral administration (gavage) to rats for 13 weeks.
Four groups of ten male and ten female Sprague-Dawley rats received the
test item,Ethoxylated (3) bisphenol A dimethacrylate,
at dose levels of 0, 100, 300 or 1000 mg/kg/day in the vehicle (corn
oil) by the oral route (gavage) once a day for 13 consecutive weeks.
The animals were checked daily for mortality and clinical signs.
Detailed clinical observations were performed once a week. Body weight
was recorded pre-test, on the first day of treatment and then once a
week. Food consumption was recorded weekly. Ophthalmological
examinations were performed on all animals before the beginning of the
study and on control- and high-dose animals in Week 13. Hematology,
coagulation, blood biochemistry investigations and urinalysis were
performed in all animals and TSH, T3 and T4 hormone levels were
determined in Week 13. On completion of the treatment period, all
animals were euthanized and a full macroscopic post-mortem examination
was performed. Designated organs were weighed and selected tissues
were preserved. A microscopic examination was performed on designated
tissues from animals in the control and high-dose groups and on all
macroscopic lesions, liver and kidneys from all low- and
No unscheduled deaths occurred during the study. The test item was well
tolerated with no relevant clinical signs and no effects on body weight,
food consumption, ophthalmological, coagulation parameters or thyroid
Slightly lower red blood cell count, hemoglobin levels and hematocrit
were noted in males and females at all dose levels. Slightly lower white
blood cell and lymphocyte counts were observed in females at all dose
levels.These slight differences were statistically significant but
poorly dose-related and comparable to historical control data, and
therefore were considered as non adverse.
Moderately higher total cholesterol levels, including HDL and LDL
cholesterol were noted in groups treated at 300 or 1000 mg/kg/day,
higher creatinine levels at 300 mg/kg/day and higher urea and creatinine
levels were noted in females at 1000 mg/kg/day. In the absence of
associated adverse histopathological findings,these changes were
considered to be non adverse.
Test item-related increased liver weights were noted in males and/or
females at 300 and 1000 mg/kg/day, and increased kidney weights in
females at 1000 mg/kg/day. At gross examination, there were test
item-related enlargement in the liver from one female treated at 1000
mg/kg/day that correlated with slight hepatocellular hypertrophy, and
small thymus that correlated with lymphoid atrophy, in one male treated
at 300 mg/kg/day and in one male treated at 1000 mg/kg/day. Test
item-related microscopic observations included non adverse increased
severity and incidence of tubular vacuolation and dilatation in the
kidney, and hepatocellular hypertrophy in males and females treated at
all dose levels.
Ethoxylated (3) bisphenol A dimethacrylate administered daily for
13 consecutive weeks by gavage to male and females Sprague-Dawley rats
at dose levels of 100, 300 or 1000 mg/kg/day was clinically well
tolerated and did not induce adverse clinical pathology or
histopathological changes. Under the experimental conditions of the
study, the No Observed Adverse Effect Level (NOAEL) was set at 1000
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