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EC number: 629-732-4
CAS number: 1224966-13-5
Tall oil fatty acids, reaction products with
polyethylenepolyamines was administered by daily oral gavage to male and
female Wistar Han rats at dose levels of 30, 100 and 300 mg/kg/day. The
males were exposed for 2 weeks prior to mating, during mating, and up to
termination (for 28 days). A total of 5 animals each of Groups 1 and 4
were allowed a 2-week recovery period. The females were exposed for at
least 42 days, i.e. 2 weeks prior to mating, during mating, during
post-coitum, and at least 4 days of lactation.
Formulation analysis showed that the
formulations were prepared accurately, were homogeneous and were stable
for at least 6 hours at room temperature.
Treatment up to 300 mg/kg/day was well
tolerated and did not result in toxicologically relevant clinical signs
or changes in body weight and food intake. A higher motor activity was
recorded for females at 300 mg/kg/day, although this was not accompanied
by supportive clinical signs (e.g. hyperactivity) or changes in
functional observation battery parameters. Therefore, this change was
not considered to be of toxicological relevance.
Clinical biochemistry measurements at the
end of treatment at 300 mg/kg/day showed notably higher alanine and
aspartate aminotransferase activity in both sexes (but without
corroborative histopathological findings, e.g. liver damage), along with
lower total protein and higher total bilirubin levels in males (within
normal range for rats of this age and strain) and higher inorganic
phosphate level in females. These changes had resolved to values
comparable to controls at the end of the recovery period for males. No
(further) changes were noted in clinical biochemistry and haematology
parameters at any dose level.
Macroscopic examination at the end of
treatment revealed a lower absolute and relative heart weight for both
sexes at 300 mg/kg/day. No histopathological correlate was found and no
such change was apparent at the end of the recovery period for males. No
(further) macroscopic abnormalities or organ weight changes were
observed at any dose level.
Histopathology showed a slight,
statistically non-significant, increase in incidence and severity of
multifocal vacuolation of the zona glomerulosa of the adrenal glands in
both sexes at 300 mg/kg/day. Following the recovery period this finding
had reverted to background incidence and severity.
No signs of parental toxicity were observed
at 30 and 100 mg/kg/day.
No reproductive/developmental toxicity was
observed at any dose level.
Overall, all parental findings observed at
the end of treatment at 300 mg/kg/day were not considered to be adverse
since these changes were generally slight and reversible in nature, and
occurred in the absence of supportive histopathological lesions.
Therefore, the parental, reproductive and developmental No Observed
Adverse Effect Level (NOAEL) of 300 mg/kg/day was derived.
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