IJT - CIR - February 2024 - 113S

Fiume et al.
113S
Table 9. Dermal Irritation and Sensitization.
Test Article
tricaprylyl/
capryl
trimellitate
Concentration/Dose Test Population
Procedure
NON-HUMAN
as supplied; .5 mL 3 White Russian
rabbits (sex
not specified)
tricaprylyl/
capryl
trimellitate
intradermal induction:
10% in FCA and
maize germ oil (1:1)
dermal induction and
challenge: undiluted
Dunkin-Hartley
guinea pigs, 20
F
A 2.5 cm2 semi-occlusive patch
with was applied to a shaved
area on the trunk for 4 h; test
sites were evaluated at 24, 48,
and 72h
GPMT intradermal induction:
administered in a mixture of
FCA and maize germ oil (1:1)
dermal induction: animals were
pretreated with 10% sodium
dodecyl sulfate on day 6; 48h
patches were applied on day 7
challenge: 24-h occlusive patch
applied on day 21
slightly irritating; PII = 1.67/8
At 24h, slight to well-defined
erythema was observed in all
animals and slight edema in 2
animals; all reactions were
reversible within 6-8days
not a sensitizer
intradermal induction: all control
and test animals had irritation
at injection sites; severe
erythema, edema and necrosis
were observed
dermal induction: at 1 h after
patch removal, both test and
control animals had erythema
and edema in the whole
application area, with inflamed
or bloody lesions; 24h after
patch removal, some animals
had erythema and eschar
formation in the application
area
Challenge: no reactions were
observed at 48 or 72h
tridecyl
trimellitate
10% in corn oil; .5 mL NZW rabbits 2
(sex not
specified)
tridecyl
trimellitate
tridecyl
trimellitate
5, 10, 25, 50, or 100%
acetone/olive oil
as supplied
NZW rabbits,
3M
24-h single occlusive patch to
intact and abraded skin; sites
scored at 24 and 72h
slightly irritating
erythema/eschar mean score -
.25/1 and .5/1 for intact and
abraded skin, respectively;
resolved by 72h
no edema
similar to OECD 404 (ie, acute
dermal irritation/corrosion
test); patch type and duration
not stated; no details provided
CBA/J mice, 4F OECD TG 429; LLNA; two
experiments were performed
HCA was used as a positive
control
triethylhexyl
trimellitate
triethylhexyl
trimellitate
as supplied; 5, 10, or
20 mL/kg
1 guinea pig/
dose (sex not
specified)
as supplied; .5 mL Californian
rabbits, 2M/2F
single 24-h occlusive patch
applied to shaved skin
single 4-h occlusive patch applied
to shaved skin
non-irritating
no erythema or edema at 24, 48,
or 72h
negative
SI >3 at 10 and 100% in
experiment 1, but not in
experiment 2
moderate erythema and
moderate to severe edema; all
animals appeared normal after
1wk
Reversible primary dermal
irritant
slight erythema was observed n
all rabbits 30-60 min after
patch removal; no effects were
observed at day 7
triethylhexyl
trimellitate
as supplied; .5 mL 6 NZW rabbits
(sex not
specified)
single 24-h occlusive patch
applied to intact and abraded
skin
not a primary skin irritant; PII =
1.04
58
30
9
9
9
29
29
Results
Reference
57
(continued)

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