IJT - CIR - February 2024 - 114S

114S
International Journal of Toxicology 43(Supplement 1)
Table 9. (continued)
Test Article
triethylhexyl
trimellitate
Concentration/Dose Test Population
Procedure
as supplied; .5 mL albino guinea
pigs, 10M
modified Buehler sensitization
assay
induction: 10 24-h occlusive
patches were applied, with a
24-h rest period between
patches
Challenge: after a 2-wk nontreatment
period, a 24-h
occlusive patch was applied to
a previously untreated site
triisodecyl
trimellitate
undiluted; .5 mL NZW rabbits,
3M/3F
24-h single occlusive patch to
intact and abraded skin; sites
were scored at 24 and 72 h
slightly irritating; PII = 1.1
24 h: slight/well-defined
erythema at 3 intact and 4
abraded sites; very slight
edema at 5 intact and 4
abraded sites; slight edema at 1
abraded site
72 h: very slight edema at 3 intact
and abraded sites
All reactions were resolved at
day 6.
HUMAN
tridecyl
trimellitate
57.1% in a lipstick
formulation
53 subjects
modified Draize HRIPT
induction: 24-h occlusive patches
with test material, applied 3x/
wk
Challenge: 24-h challenge patch
applied to a previously
untreated site after a 2-wk
non-treatment period; test
sites were evaluated 24 and
72 h after application
tridecyl
trimellitate
triethylhexyl
trimellitate
1% in acetone
undiluted; .2 mL 51 subjects
HRIPT (same procedure as
above)
203 subjects HRIPT (as above, except semiocclusive
patches were used;
challenge reactions were
evaluated at 48 and 96 h)
not an irritant or a sensitizer
not a sensitizer
induction: erythema in 4 subjects
on 4-6 occasions
Challenge: slight erythema in 2
subjects at 48 h; 1 at 48 and 96
h; and 1 at 96 h (these subjects
did not have irritation during
induction)
Abbreviations: FCA, Freund's Complete Adjuvant; GPMT, guinea pig maximization test; HCA, α-hexylcinnamaldehyde; HRIPT, human repeated insult patch test;
LLNA, local lymph node assay; NZW, New Zealand White; OECD, Organisation for Economic Development; PII, primary irritation index; SI, stimulation index;
TG, test guidelines.
and tridecyl trimellitate was slightly irritating to rabbit eyes9
(Table 10).
Summary
This report addresses the safety of 5 trialkyl trimellitates as
used in cosmetics. The trialkyl trimellitates are structurallyrelated
as alkyl esters of trimellitic acid, most commonly
manufactured by esterifying trimellitic anhydride, and the
only structural difference between these ingredients is the
length/branching of the alkyl chains. According to the International
Cosmetic Ingredient Dictionary and Handbook,
these ingredients are reported to function in cosmetics as skin
conditioning agents, and, tricaprylyl/capryl trimellitate and
triethylhexyl trimellitate are also reported to function in
cosmetics as plasticizers.
VCRP data obtained from the FDA, and data received in
response to a survey of the maximum reported use concentration
by product category conducted by the Council, indicate
that 4 of the 5 ingredients included in this safety assessment
9
61
not an irritant or a sensitizer
60
56
Results
not a primary irritant, fatiguing
agent, or sensitizer
Reference
59

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