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EC number: 695-097-5
CAS number: 15789-90-9
The oral administration of the test material to rats for a period of
ninety consecutive days at dose levels of 5, 30 and 500 mg/kg/day
resulted in treatment related effects in males at 500 and 30 mg/kg/day
and in females at 500 mg/kg/day. The No Observed Effect Level (NOEL) was
considered to be 30 mg/kg/day for females and 5 mg/kg/day for males.
A study was conducted to investigate the systemic toxicity of the test
material. The test material was administered by gavage to three groups,
each of ten male and ten female Sprague-Dawley Crl:CD(SD)IGS BR strain
rats for 90 consecutive days. A control group of ten males and ten
females was dosed with the vehicle alone (corn oil). The animals were
acclimatised for 6 days. At the start of treatement the males weighed
131 to 172 grams and the females weighed 122 to 155 grams. The animals
were approximately 6-8 weeks old. Animals were housed in groups of three
or four by sex in polypropylene grid-floor cages suspended over trays
lined with absorbent paper. The animals were allowed free access to food
and water. A pelleted diet (Rodent 5LF2 (Certified) Diet) was used.
Mains drinking water was supplied from polycarbonate bottles attached to
the cage. The animals were housed in a single air-conditioned room with
an air exchange rate of at least 15 air changes per hour and the low
intensity lighting was controlled to give twelve hours continuous light
and twelve hours darkness. The temperature and relative humidity were
set to achieve target values of 21 +/- 2 C and 55 +/- 15%, respectively.
Dose levels were 5, 30 and 500 mg/kg/day at a volume of 4 ml/kg. All
animals were examined for overt signs of toxicity, ill-health or
behavioural changes immediately before dosing and one and five hours
after dosing during the working week. Animals were observed immedately
before dosing and one hour after dosing at weekends. Prior to the start
of treatment and at weekly intervals thereafter, all animals were
observed for signs of functional/behavioural toxicity. Functional
performance tests were also performed on all animals during Week 12, together
with an assessment of sensory reactivity to different stimuli. Clinical
signs, functional observations, bodyweight development and food and
water consumption were monitored during the study. Haematology and blood
chemistry were evaluated for all animals at the end of the study.
Ophthalmosscopic examination was also performed on control and high dose
animals (500 mg/kg). All animals were subjected to gross necropsy
examination and histopathological evaluation of selected tissues was
performed Statistical analyses were performed.
There were no unscheduled death and no clinical sings of toxicity
observed. No adverse effects on bodyweight, dietary intake or food
efficiency and treatment-related haematology changes were detected. A
statistically significant increase in liver and kidney weights both
absolute and relative was observed in animals treated with 500 mg/kg/day
and a significant increase in plasma creatinine, total protein and
cholesterol were also observed in high-dose animals. Histopathology
revealed an enlargement of hepatocytes in the liver (generally regarded
as adaptive in nature) of animals treated with 500 mg/kg/day. Males
treated with 500 mg/kg/day also showed a significant increase in spleen
weight and in plasma albumin. No abnormalities were observed at
necropsy. A greater incidence of globular accumulations of eosinophilic
material in the kidney’s tubular epithelium was noted in males treated
with 30 and 500 mg/kg/day and a higher incidence of follicular cell
hypertrophy in thyroid and adipose infiltration of the bone marrow
(indicative of morrow hyperplasia) in males treated with 500 mg/kg/day.
The NOEL was considered to be 30 mg/kg/day for females and 5 mg/kg/day
for males. Because the kidney changes noted in male rats were consistent
with well documented changes that are peculiar to the male rat in
response to treatment with some hydrocarbons, the NOAEL for males may be
considered to be 30 mg/kg/day.
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