IJT - CIR - February 2024 - 107S

Fiume et al.
107S
Table 6. (continued)
Ingredient
triethylhexyl
trimellitate
Dose/
Crj:CD (SD) rats,
5M/5F
Animals/Group Study Duration Vehicle
28-day
corn
oil
Concentration
0, 100, 300, or
1000 mg/kg
Results
None of the animals died during the
study, and no signs of toxicity, test
article-related changes were
observed in mean body weights, feed
consumption, clinical chemistry,
hematology, or organ weights.
NOAEL was >1000 mg/kg/day in male
and female rats
triethylhexyl
trimellitate
Fischer 344 albino
rats, 5M
28-day
corn
oil
1000 mg/kg/day None of the animals died during the
study, and there were no significant
effects on body weight, absolute liver
weights, or relative liver-to-body
weight ratios. The only remarkable
effect was a significant decrease in
triglyceride values in the test animals
triethylhexyl
trimellitate
Fischer F344 rats,
5M/5F
28-day
feed 0, .2, .67, or 2.0% No statistically significant effects on feed
consumption or body weight gains
were observed. Hepatomegaly was
observed in males and females of the
mid and high dose groups; a slight
reduction in the cytoplasmic
basophilia in 2/5 females of the high
dose group the only microscopic
change reported in the livers;
NOAEL was .2%; LOAEL was .67%
triethylhexyl
trimellitate
Sprague-Dawley
rats; 10M/10F
90-day, with high
dose recovery
group
feed 0, 50, 225, or 1000
mg/kg/day
No signs of toxicity; no effect on feed
consumption or body weight gains;
dose-related statistically significant
increase in absolute liver weights in
high dose females, and a statistically
significant increase in relative liver
weights in high dose males and
females; absolute and relative spleen
weights were decreased in high dose
males; some microscopic lesions in
the liver and spleen were observed;
no significant effect on the estrous or
spermatogenic cycles; absolute and
relative liver weights were slightly
increased in females, but not males, at
the end of recovery; no other
significant changes were observed at
the end of treatment or recovery
periods
NOAEL was 225 mg/kg bw/day; LOAEL
was 1000 mg/kg bw/day
Abbreviations: LOAEL, lowest observable adverse effect level; NOAEL, no-observable adverse effect level.
Non-Human
OralTriethylhexyl Trimellitate
A group of 12 male albino rats was dosed by gavage with
300 mg/kg/day triethylhexyl trimellitate in corn oil, 6 days/
wk, for 4 wk; 6 of the animals were killed one day after
administration of the last dose, and the other 6 served as a 4wk
recovery group.44 Two control groups of 6 male rats each
were used; one group was administered distilled water, and the
other 5 mL corn oil, by gavage 6 days/wk for 4 wks. Liver
specimens were taken from each animal at study termination.
Triethylhexyl trimellitate had mild reversible effects in the
liver. In the test animals, a preserved lobular architecture with
generalized vascular dilation and congestion and many
shrunken hepatocytes with euchromatic nuclei and lipid
42
Reference
41
39
32

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