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EC number: 254-996-9
CAS number: 40601-76-1
This report presents the results of a very minimal, "range-finding"
study that was undertaken to provide a basis for establishing dietary
levels for a full-scale, 90-day study.
The test material was administered daily for 30 days to rats by dietary
admixture at concentrations of 0.5, 1.0 and 2.0%. There ware no deaths
in any of the control or treatment groups. Food consumption, body weight
gain, and organ weight (liver and kidneys) were slighlty affected by the
The only significant observation seen at necropsy was discoloration of
the liver. Histopathological examination of liver sections from 4 high
dose rats whoed no effects that could be attributed to the
administration of the test substance. Thus, this liver discoloration is
Sprague-Dawley rats were used in this study. 20 males and 20 females
were assigned to control, and to each of the test groups (25, 100 and
400 mg/kg). The length of the treatment period was 90 days.
There were no specific effects noted on the reproductive organs of the
rats. Therefore it is concluded that the test material did not affect
adversely those organs after 90 days of administration at the highest
dose tested. The NOEL is 400 mg/kg bw.
One animal in the mid-dose group (100 mg/kg) died after 12 days of
treatment but was an isolated case and so not related to administration
of test material. Animals were generally healthy during the study, but
exhibited alopecia around the nares and paws, diarrhea, watery eyes
(animals that were bled, only) and encrustment around the nares. These
signs were attributed to ingestion of a powdered food and were not
considered to be related to test material.
Food intake was measured weekly, other than a random week where a
particular test group ate less food than comparable test groups or
control groups, there was no significant difference in food intake
between control and test animals in any sex grouping. Animals were
weighed initially and then weekly thereafter. Weight gains were
essentially comparable in treated and control groups with only a sex
difference noted; males gained more weight than females.
Gamma-glutamyl transpeptidase (GGTP), glutamix-oxaloacetic
transpeptidase, glutamic-pyruvic transaminase and urea were measured at
90 days in 5 males and 5 females from each test group. GGTP values were
variable within the different dose groups but were within the values
usually observed in this strain of rat. Glucose levels of treated
animals were lower than controls but were within the range of normal
values reported for this strain of rat. Since there were not
statistically significant differences between the means of treated
animals, the significant difference between the high-dose females and
their control was considered to be a result of some unusually high
values among the controls and was not considered to be the result of
administering the test material. Glutamic-oxaloacetic transaminase,
Glutamic-pyruvic transaminase and urea were unaffected by the treatment.
At 45 days, no changes in erythrocyte counts were noted. At 90 days,
there was a trend toward increased red blood cells in low and mid-dose
animals; however, counts in high dose animals were similar to controls.
Since the increase was not dose-related, this observation was thought to
be artifactual in nature and not related to administration of test
material. There were no changes in hematocrit, hemoglobin, leukocyte
count, platelet estimate and erythrocyte morphology.
There was no effect of treatment on urinalysis, organ weights, or gross
pathology. One of the males with a high GGTP value had focal
perivascular and periductal mononuclear leukocyte infiltration in the
liver, but the other animal did not demonstrate any liver pathology.
Livers of other males in the high dose group had histopathology similar
to that of controls. Other mild inflammatory lesions characterized by
leukocytic infiltration also occurred in the lungs, liver and kidneys of
a few animals in each group. All changes were considered to be
spontaneous and not related to administration of test material.
Therefore it is concluded that the test material did not affect
adversely the rats after 90 days of administration at the highest dose
tested. The NOAEL is 400 mg/kg bw.
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