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EC number: 256-062-6
CAS number: 43048-08-4
Table 1. Hematology data
White blood cells (G/L)
Red blood cells (T/L)
Packed cell volume (L/L)
Table 2. Blood biochemistry data
Table 3. Main organ weight changes (in
Exam. animals / Num. of animals
significant from controls: *: p<0.05, **: p<0.01.
significance concerned the organ weights values and not the percentages.
Table 4.Test item-related microscopic
finding in liver (incidence and severity)
Examined animals / Total number of animals
Increased vacuolation; hepatocytes
. grade 1
. grade 2
The objective of this study was to
evaluate the potential toxicity of the test
item,Tricyclodecane dimethanol diacrylate, following daily oral
administration (gavage) to rats for 4 weeks,according to OECD (No. 407,
3rd October 2008) and EC (No. 440/2008, B7, 30th May 2008) guidelines.
The study was conducted in compliance
with the principles of Good Laboratory Practice Regulations.
Three groups of five male and five
female Sprague-Dawley rats received the test item, Tricyclodecane
dimethanol diacrylate, by daily oral administration for 28 days at
dose-levels of 100, 300 or 1000 mg/kg/day. The test item was
administered as a solution in the vehicle (corn oil) at a constant
dosage-volume of 5 mL/kg/day. A control group of five males and five
females received the vehicle alone under the same experimental
Test item concentrations were checked
on formulations used in Weeks 1 and 4.
The animals were checked at least
twice daily during the dosing period for mortality and morbidity and
once daily for clinical signs. In addition, detailed clinical
examinations were performed at least once weekly. Body weight was
recorded once before the beginning of the treatment period, and then at
least once a week during the study as food consumption. Towards the end
of the dosing period, a Functional Observation Battery including motor
activity measurement, and hematology, blood biochemistry and urinalysis
were performed on all animals.
On completion of the treatment period,
the animals were euthanized and submitted to a full macroscopic post-mortem
examination. Designated organs were weighed and selected tissues
were preserved. A microscopic examination was performed on selected
tissues from control- and high-dose animals sacrificed at the end of the
treatment period and on all macroscopic lesions.
The test item concentrations in the
administered dose formulations analyzed in Weeks 1 and 4 were within the
acceptance criteria (± 10% of the nominal values).
There were no unscheduled deaths, no
test item-related clinical signs or effects at the Functional
Observation Battery including motor activity. There were no
toxicologically significant effects on mean body weight, mean body
weight change or mean food consumption.
Males treated at 1000 mg/kg/day had a
mean neutrophil count and a mean urine pH lower than controls (0.91vs.
1.54 G/L and 6.0 vs. 6.7, respectively, p<0.05) that were
considered to be of limited toxicological significance.
In females treated at 1000 mg/kg/day,
mean glucose and cholesterol levels were higher than in controls (6.85 vs.
6.02 mmol/L and 1.80 vs. 1.45 mmol/l, respectively, p<0.05)
which were considered to be of minimal toxicological significance.
Increased absolute and
relative-to-body liver weights were seen in females at 100, 300, and
mostly at 1000 mg/kg/day. These differences correlated with microscopic
non adverse increased vacuolation of periportal hepatocytes noted in
these females at 100, 300 and 1000 mg/kg/day. Vacuolated hepatocytes
were also observed in two males given 1000 mg/kg/day.
Under the experimental conditions of this
study, following daily administration of the test item for 4 weeks by
oral route to male and female Sprague-Dawley rats at dose levels of 100,
300 or 1000 mg/kg/day in corn oil, the No Observed Adverse Effect Level
(NOAEL) was considered to be at 1000 mg/kg/day in absence of adverse
effects at this dose.
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