IJT - CIR - February 2024 - 109S

Fiume et al.
109S
Table 7. Reproductive and Developmental Toxicity Studies.
Test Article
Animals/
Group Vehicle
tricaprylyl/
capryltrimellitate
(alcohol side-chains
consisted of 40-60%
linear C8-alcohol and
40-60% linear C10alcohol)
24
gravid
SpragueDawley
rats
corn
oil
Dose/
Concentration
ORAL
0,
100, 300, or
1000 mg/kg bw/
day
Animals were dosed by
gavage on GD 6-19, and
killed on GD 20. The
animals were observed
for clinical signs of
toxicity during the
study, the ovaries and
uterine content were
examined at study
termination, and fetal
examinations were
performed.
1000 mg/kg bw group:
increase in staining on the
body, primarily around
the head; statistically
significant decreases in
body wt (from day 12),
body wt gains (from day
9), feed consumption
(from day 9), terminal
body wts, uterine wts,
and absolute body wts,
fetal wts and
consequently litter wts
compared to the
controls; a delay in
ossification was
considered a result of the
maternal toxicity
observed at this dose; no
other embryotoxic or
teratogenic effects were
reported
NOAELs were 300 mg/kg
bw/day for maternal
toxicity and 1000 mg/kg
bw/day for fetal toxicity
tricaprylyl/capryl
trimellitate
24 gravid
Han
Wistar
rats
corn
oil
0 or 500 mg/kg
bw/day
Examined effect on TMD.
Dams were dosed on GD
12-19, and killed on GD
19. Testes from a
minimum of 5 litters/
group were examined for
changes in gene
expression in pathways
relevant to TMD by
transcription profiling
analysis of RNA. DEHP
was used as a positive
control
triethylhexyl trimellitate 3-4 gravid
SpragueDawley
rats
corn
oil
0,
250, 500, or
1000 mg/kg
bw/day
Animals were dosed by
gavage on GD 14-18, and
killed approximately 2h
after the last dose. Fetuses
were removed
immediately and
necropsied within 2h. (2
trials)
No significant repressive
effect on genes in the
TMD pathway; positive
control caused a
repression of genes
involved in testes
development and
cholesterol and
testosterone biosynthesis
29
29
Procedure
Results
Reference
No statistically significant
effects on testicular
testosterone production,
fetal viability, or maternal
body wt gains
46
(continued)

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