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EC number: 203-838-7
CAS number: 111-14-8
The objective of this study was to
evaluate the potential toxicity of the test item following daily oral
administration (gavage) to rats for 13 weeks.
Three groups of ten male and ten
female Sprague-Dawley rats received the test item at dose-levels of 100,
300 or 1000 mg/kg/day (groups 2 to 4). In addition, one group of ten
males and ten females received the control item alone (corn oil) and
acted as a control group (group 1). The control and test items were
administered by oral route during a 13-week period at a constant
dosage-volume of 5 mL/kg/day.
The concentration of the dose
formulation was checked in study weeks 1, 5, 9 and 13.
The animals were checked daily for
mortality and clinical signs. Detailed clinical examinations were
performed once a week. 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. Ophthalmological examinations were
performed on all animals before the beginning of the treatment period
and in control- and high-dose groups at the end of the treatment period.
Towards the end of the dosing period, a Functional Observation Battery
including motor activity measurement, and hematology, blood biochemistry
and urinalysis investigations were performed on all animals. Estrous
cycle was monitored on all females during the last 3 weeks of the
On completion of the treatment period,
the animals were euthanized and submitted to a full macroscopic post-mortem
examination. Sperm investigations were performed at sacrifice of the
males. 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, 5, 9 and 13 were
within the acceptable range of variation when compared to the nominal
There were no heptanoic acid-related
deaths during the study and no clinical signs at 100 and 300 mg/kg/day.
At 1000 mg/kg/day, treatment-related clinical signs were limited to
ptyalism considered to be ofminimal toxicological significance. No
findings were observed at ophthalmology examination. There were no
toxicologically significant effects on mean body weight, mean body
weight change and at hematology, blood biochemistry and urinalysis
At 1000 mg/kg/day and compared to
controls, a statistically significant lower or higher mean food
consumption was observed in week 9 (female; -23% from controls) or in
weeks 12 and 13 (males; +10 and +16%) considered of limited
There were no relevant effects at the
Functional Observation Battery including motor activity and inmean sperm
parameters (epididymal motility, morphology and count, testicular sperm
count). There were no toxicologically relevant effects on mean estrous
There were no test item-related organ
weight differences or gross findings. At microscopic examination,
non-adverse findings (hyperkeratosis and hyperplasia of squamous cells)
in the forestomach were found in males and females treated at 300 or
1000 mg/kg/day. The hyperplasia of squamous cells and the hyperkeratosis
were considered as non-adverse because of their low magnitude and
because they were not associated with any degenerative or inflammatory
The test item was administered daily
to Sprague-Dawley rats, by oral route, at dose-levels of 100, 300 or
1000 mg/kg/day for 13 weeks.
There were no adverse findings in the
The test item-related hyperplasia of
squamous cells with hyperkeratosis observed in the forestomach from
males and females treated at 300 or 1000 mg/kg/day were considered as
non-adverse because of their low magnitude and because they were not
associated with any degenerative or inflammatory reaction.
Under the experimental conditions of
this study, the No Observable Adverse Effect Level (NOAEL) was
considered to be 1000 mg/kg/day.
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