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EC number: 233-072-9
CAS number: 10028-22-5
was intended to evaluate NOAEL (No Observed Adverse Effect Level) on
reproduction process such as mating, conception, gestation, childbirth
and development of neonates and the effect on the whole body including
nerve and immune systems when female rats were orally dosed with Iron
dichloride (CAS No.7758-94-3) once a day up topost partumday 4
from two weeks prior to the mating and male rats were orally dosed once
a day with iron dichloride till two weeks before and after the mating.
female SD rats were dosed with the test substance (0 (Control group),
125, 250 and 500 mg/kg/day) from two weeks before mating. Male SD rates
were dosed once a day till two weeks after mating while female SD rats
were dosed once a day up topost partumday 4. A total of 42 doses
were provided for male rats while female rates had 42 to 54 dosages
depending on mating and delivery of individuals. Clinical signs and
mortality were observed and body weight and food and water consumption
were measured. In the necropsy, gross examination of organs and tests on
corpus luteum graviditatis and implantation rates were conducted. In
addition, tests for sensory and motor functions, urinalysis and
hematological and blood chemical tests were given and organ weights were
measured for five individuals randomly selected from each group.
External abnormalities, sex ratio, body weights, CRL (Crown Rump Length)
and survival rate were observed onpost partumdays 0 and 4.
observation period, the main group dosed with the substance showed signs
such as melaena (black stool) and salivation but these signs were
observed to disappear after dosing in the recovery group. There was no
mortality in male SD rats, but three mortalities took place in female
individuals at 500 mg/kg. The cause for mortalities was presumably the
gastrointestinal damage by the substance. It was found that male
individuals were more sensitive to body weight and food consumption than
female counterparts. The change by the test substance was not recognized
in mating data, sensory functions, motor functions, urine analysis and
blood test. Gastric hemorrhage with blackened liver and black
pigmentation of liver discovered in the necropsy findings was presumed
to be caused by the test substance, but it was found to improve for the
recovery period of two weeks. Weight changes in the liver and adrenal
were observed in the absolute and relative organ weights of male
individuals at 250 and 500 mg/kg and female individuals at 500 mg/kg. The
histopathological test found parenchymal hemosiderosis and hyperplasia
of adrenocortical zona fasciculate as well. It was found that the
substance had no effect on birth rate, survival rate, body weight and
CRL of neonates.
As a result
of the test using iron dichloride (CAS No.7758-94-3), the NOAEL of
repeated doses to male and female SD rats were 125 and 250 mg/kg/day,
there was no difference observed in reproductive functions of male and
female SD rates and development of neonates between the control group
and main group, NOAEL was thought to be 500 mg/kg/day. The effect of the
test substance was none on reproductive functions, sensory functions,
motor functions, urinalysis, and hematological and blood chemical
findings which showed no differences between the control group and main
group. Except the body weight change of male SD rats, clinical signs,
water consumption, organ weights, necropsy findings and
histopathological findings were reversible as they recovered after the
dosing was over.
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