IJT - CIR - February 2024 - 106S

106S
International Journal of Toxicology 43(Supplement 1)
Table 6. Repeated Dose Toxicity Studies.
Ingredient
tricaprylyl/
capryl
trimellitate
Sprague-Dawley
rats, 5M/5F
Dose/
Animals/Group Study Duration Vehicle
28-day, with 2-wk
high-dose and
control
recovery
groups
corn
oil
Concentration
ORAL
0, 100, 300, or
1000 mg/kg/day
by gavage
All animals survived until study
termination
Treatment-related effects were
observed in males and, to a minor
extent in females, of the high dose
group included hair loss in 6/10
females; a decrease in mean body
weights that continued until the end
of the recovery period; reversible,
slight but statistically significant
increases in absolute and relative liver
weights in males and females and a
reversible increase in the absolute
and relative adrenal weights in males;
and reversible microscopic changes
in the adrenal glands of high dose
males. No microscopic changes were
observed in the reproductive organs
NOAEL was 300 mg/kg/day
tricaprylyl/
capryl
trimellitate
Sprague-Dawley
rats, 10M/10F;
5M/5F
recovery
animals
13 wk, with 4-wk
high-dose and
control
recovery
groups
corn
oil
0, 50, 200, or 500
mg/kg/day, by
gavage
Clinical and neurobehavioral
observations, body wts and feed
consumption were recorded, clinical
chemistry, hematology, and urinalysis
parameters were measured, vaginal
smears were taken from wk 12 until
study termination, a detailed
evaluation of testes was performed
on all control and high dose males,
including an examination of the
spermatogenic cycle, and gross and
microscopic examinations at
necropsy, including microscopic
examination of the testes,
epididymides, and seminiferous
epithelium; any observed changes,
including wt and microscopic changes
in the liver, were fully reversible and
therefore not considered
toxicologically significant
NOAEL was 500 mg/kg/day
triethylhexyl
trimellitate
Fischer F344 rats,
5M/5F
21-day
corn
oil
0, 200, 700, or
2000 mg/kg/day
No effect on feed consumption or body
weight gains.
A statistically significant, non-dose
related, increase in relative liver
weights was observed in females of all
dose groups; no effect on relative
liver weights was observed in the
males of any dose group; only
remarkable microscopic effects in the
livers was a reduction in the quantity
of neutral lipids
(continued)
29
29
Results
Reference
39,40

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