IJT - CIR - February 2024 - 111S

Fiume et al.
111S
Table 7. (continued)
Test Article
Animals/
Group Vehicle
triethylhexyl trimellitate gravid Han
Wistar
rats
corn
oil
Dose/
Concentration
0 or 500 mg/kg
bw/day
Procedure
Examined effect on TMD (as
above). DEHP and MEHP
were used as a positive
controls
Results
No significant repressive
effect on genes in the
TMD pathway; positive
controls caused a
repression of genes
involved in testes
development and
cholesterol and
testosterone biosynthesis
Abbreviations: DEHP, diethylhexyl phthalate; GD, gestation day; LD, lactation day; MEHP, mono-2-ethylhexyl phthalate; NOAEL = no-observable adverse effect
level; NOEL, no-observable effect level; PND, postnatal day; TMD, testicular mal-development.
and ERβ reporter cells were 8.1 and 4.9 µM, respectively. The
estradiol equivalence factors (EEF10; i.e., EC10 estradiol/EC10
triethylhexyl trimellitate) in the ERα and ERβ were 1.2 × 107 and
1.6 × 106, respectively; the EEF10α/EEF10β ratio was .0075.
When compared to estradiol, the maximum estrogenic effect
of triethylhexyl trimellitate in ERα cells was 113% of that
found with estradiol, and in the ERβ cells, it was 76% of that
found with estradiol.
Genotoxicity
Tricaprylyl/capryl trimellitate and triethylhexyl trimellitate
were not genotoxic in the Ames test using Salmonella typhimurium,
a mammalian cell gene mutation assay in mouse
lymphoma cells, or a chromosomal aberration assay in
human lymphocytes or Chinese hamster lung fibroblasts (for
triethylhexyl trimellitate), and triethylhexyl trimellitate was
not genotoxic in a forward mutation assay in Chinese hamster
ovary cells, unscheduled DNA synthesis assay in rat primary
hepatocytes, or dominant lethal assay in mice29,32,50-54
(Table 8). Also, when the mutagenicity of urine from rats
dosed with triethylhexyl trimellitate was evaluated in the
Ames test, there was no evidence that mutagenic substances
were excreted in the urine by rats.55
Carcinogenicity
Carcinogenicity data on the trialkyl trimellitate ingredients
were not found in the published literature, nor were unpublished
data provided.
Irritation and Sensitization
Dermal Irritation and Sensitization
Undiluted tricaprylyl/capryl trimellitate, 10% tridecyl trimellitate,
and triisodecyl trimellitate were slightly irritating to
rabbit skin following a single occlusive application, but undiluted
tridecyl trimellitate was non-irritating to mouse
skin9,29,56 (Table 9). A single occlusive application of undiluted
triethylhexyl trimellitate produced reversible moderate
erythema and moderate to severe edema in guinea pig skin30;
triethylhexyl trimellitate was a reversible primary dermal irritant
in Californian rabbits,57 but it was not a primary irritant
in New Zealand White rabbits.58 Tricaprylyl/capryl trimellitate
(10% at induction/undiluted at challenge) was not a
sensitizer in a guinea pig maximization study,29 and undiluted
triethylhexyl trimellitate was not a sensitizer in a Buehler
sensitization assay in guinea pigs.59 Up to 100% tridecyl
trimellitate was negative in a local lymph node assay.9 In
human repeated insult patch tests, tridecyl trimellitate (57.1%
in a lipstick formulation and undiluted)9,60 and 1% triethylhexyl
trimellitate in acetone were not sensitizers.61
Phototoxicity
Human
Tridecyl Trimellitate. The phototoxicity potential of a lipstick
containing 22.3% tridecyl trimellitate was evaluated in
10 fair-skinned subjects with skin types I, II, or III.62 On day 1
of the study, occlusive patches containing approximately .1 g
ofthe test material, a dark red waxy solid, were applied (neat)
to both volar forearms of each subject. On day 2, the patches
were removed and one arm ofeach subject was irradiated with
a dose of∼.22 J/cm2/min ultraviolet A (UVA) from 4 F40BL
florescent tubes (the wavelength range was 320-400 nm, and
over 95% of the relative energy at 360 nm) for 15 min, for a
total dose of3.3 J. The responses at the test sites on both arms
were evaluated on days 3 and 4. No reactions were observed at
the irradiated or non-irradiated sites. A lipstick formulation
containing 22.3% tridecyl trimellitate was not irritating and
did not induce a phototoxic response.
Ocular Irritation
Tricaprylyl/capryl trimellitate, triethylhexyl trimellitate, and
triisodecyl trimellitate were not irritating to rabbit eyes,29,56,63
Reference
32

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