IJT - CIR - February 2024 - 112S

112S
International Journal of Toxicology 43(Supplement 1)
Table 8. Genotoxicity Studies.
Test Article
tricaprylyl/capryl
trimellitate
tricaprylyl/capryl
trimellitate
tricaprylyl/capryl
trimellitate
Concentration/
Vehicle
Procedure
IN VITRO
8-5000 µg/plate in
DMSO
156-2500 µg/mL in
ethanol
313-1250 µg/mL in
ethanol
Ames test, with or without metabolic
activation; appropriate positive controls
were used.
Mammalian cell gene mutation assay, with
and without metabolic activation;
vehicle and appropriate positive
controls were used
Chromosomal aberration assay; 24h
harvest time; vehicle and appropriate
positive controls were used 3h
exposure with and without metabolic
activation
625-2500 µg/mL in
ethanol
triethylhexyl
trimellitate
triethylhexyl
trimellitate
triethylhexyl
trimellitate
triethylhexyl
trimellitate
0-5000 µg/plate in
acetone
0-10,000 µg/plate
in DMSO
0-2500 µg/mL in
ethanol
0-5000 µg/plate in
ethanol
24h exposure without metabolic activation
Ames test, with and without metabolic
activation; appropriate positive controls
were used.
Ames test, with or without metabolic
activation; appropriate positive controls
were used.
mammalian cell gene mutation assay;
appropriate positive controls were used
chromosomal aberration assay, with and
without metabolic activation; 2 assays,
one with a 3h and one with a 24h
treatment; appropriate controls were
used
triethylhexyl
trimellitate
0-5.0 mg/mL in
acetone
chromosomal aberration assay, with and
without metabolic activation; shortterm
(6h) and continuous (24 or 48h)
treatments; appropriate controls were
used
triethylhexyl
trimellitate
triethylhexyl
trimellitate
urine from rats
dosed with
triethylhexyl
trimellitate
0-200 nL/mL in
ethanol
0-5000 nL/mL in
ethanol
≤2 mL undiluted
test material
CHO/HGPRT forward mutation assay,
with and without metabolic activation;
appropriate positive controls were used
unscheduled DNA synthesis assay;
appropriate positive controls were used
Ames test using a direct plating procedure,
with and without metabolic activation at
least 6 male Sprague-Dawley rats were
dosed by gavage with 2000 mg/kg bw/
day for 15 days; urine samples were
collected daily; a vehicle (corn oil) and a
positive control (8-hydroxyquinoline)
was used
IN VIVO
triethylhexyl
trimellitate
1400 mg/kg bw
(vehicle not
specified)
dominant lethal assay; details not provided male Swiss mice
Abbreviations: CHO - Chinese hamster ovary; DMSO - dimethyl sulfoxide; E. - Escherichia; S.- Salmonella.
negative
32
S. typhimurium TA98
TA100, TA1535,
and TA1537; E. coli
WP2 uvrA
S. typhimurium TA97,
TA98 TA100, and
TA1535
mouse lymphoma
L5178Y cells
negative
negative
negative
human lymphocytes negative
50
S. typhimurium TA97,
TA98 and TA100
L5178Y cells
negative
negative
in human peripheral
blood lymphocytes
not genotoxic
with either
exposure
time
29
29
Test System
Results
Reference
29
51
32
32
Chinese hamster lung
fibroblasts (V79
cells)
CHO cells
rat primary
hepatocytes
S. typhimurium TA97,
TA98 TA100,
TA1535, and/or
TA1537
negative
32,52
negative
negative
negative
53
54
55

IJT - CIR - February 2024

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IJT - CIR - February 2024 - 111S
IJT - CIR - February 2024 - 112S
IJT - CIR - February 2024 - 113S
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IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
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