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EC number: -
CAS number: -
Tallow Tripropylenetetramine was
administered by daily oral gavage to male and female Wistar Han rats at
dose levels of 0, 30, 100 or 300 mg/kg/day. The males were exposed for 2
weeks prior to mating, during mating, and up to termination (for at
least 28 days). The females were exposed for 42-54 days, i.e. 2 weeks
prior to mating, during mating, during post-coitum, and at least 4 days
Formulation analysis showed that the
formulations were prepared accurately, were homogeneous and were stable
for at least 6 hours at room temperature.
All animals at 300 mg/kg were killed in
extremis on Day 10 of treatment. Microscopic findings in the stomach
(including ulcers and erosions, corresponding to irregular surface of
the forestomach at necropsy) were considered to have contributed to the
moribundity. Prior to death these animals primarily showed hunched
posture and piloerection, along with notable weight loss (up to 13%) and
reduced food intake. At necropsy, all sacrificed animals showed
yellowish contents of the gastro-intestinal tract, irregular surface of
the forestomach, dilation of the small intestines or caecum and reduced
size of the thymus. Histopathological changes other than stomach effects
noted at 300 mg/kg/day included hypertrophy of the epithelium of the
duodenum, jejunum, ileum and caecum with or without foamy macrophages in
the villi, foamy macrophages in the mesenteric lymph nodes, and lymphoid
atrophy of the thymus, corresponding to dilation of the small intestines
or caecum and reduced size of the thymus at necropsy.
At 100 mg/kg, one male and one female were
killed in extremis on Day 27 and 38 of treatment, respectively. For one
of these animals findings in the stomach (including an ulcer) were
considered to have contributed to the moribundity, whilst for the other
animal no clear cause of moribundity was established
histopathologically. Clinical signs at 100 mg/kg/day primarily consisted
of piloerection among females. In addition, lower absolute body weights
and body weight gain were recorded during the Repro period for males and
females, and for females also during post-coitum and lactation. Also,
absolute and relative food consumption of females was lower than
controls during the premating phase, and remained lower during the
post-coitum period, but not during lactation. Clinical biochemistry
changes in males and/or females consisted of higher alanine and
aspartate aminotransferase activity, lower total protein and albumin
levels, and higher total bilirubin, urea, cholesterol and bile acid
levels. Haematological changes were confined to a higher relative and/or
absolute neutrophil count, and higher platelet counts. Necropsy revealed
lower liver, spleen, prostate, heart and thymus weight in males and/or
females, which may at least in part be explained by the lower terminal
body weights. Histopathological changes among the surviving animals
consisted of hypertrophy of the epithelium and/or foamy macrophages in
the villi of the duodenum, jejunum, ileum and caecum, lymphoid atrophy
of the thymus and macrophage foci in the mesenteric lymph node.
At 30 mg/kg/day, a lower body weight gain
was recorded for males during the Repro period without changes in food
intake. Haematology showed a higher relative neutrophil count in
females, but absolute neutrophil counts remained similar to controls.
Clinical biochemistry parameters remained unaffected. Histopathological
changes consisted of foamy macrophages in the villi of the ileum and
jejunum, hypertrophy of the epithelium of the caecum and macrophage foci
in the mesenteric lymph node.
No treatment-related changes were noted
during functional observation tests at any dose level.
No toxicologically relevant differences in
reproductive/developmental parameters occurred up to 100 mg/kg/day. No
potential effect on reproductive/developmental parameters could be
determined at 300 mg/kg since all animals were sacrificed at this dose
Since all animals were sacrificed at 300
mg/kg/day, and hence no potential effect on reproductive/developmental
parameters could be determined at this dose level, the reproductive and
developmental NOAEL was established to be 100 mg/kg/day.
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