IJT - CIR - February 2024 - 44S

44S
International Journal of Toxicology 43(Supplement 1)
Table 7. Dermal Irritation and Sensitization Studies.
Ingredient
Concentration/Dose
Irritation - Animal
Capryl Sultaine
Method
Results
Formulation containing .25% Dermal irritation study in 6
rabbits (strain not specified);
undiluted test material applied
as single .5 mL dose to intact
and abraded 1 in 2 areas for
24 h
Cocamidopropyl
Hydroxysultaine
41.5% aqueous solution
Dermal irritation study in 3 male
New Zealand White rabbits in
accordance with OECD TG
404; test material applied as a
single .5 mL dose to a shaved 6
cm2 area of intact skin for 4 h
with a semi-occlusive patch
Cocamidopropyl
Hydroxysultaine
16% solids aqueous solution
Dermal irritation study in 2 male
and 1 female New Zealand
White rabbit in accordance
with 16 CFR § 1500.41; test
material applied to clipped
abraded and non-abraded skin
(∼10% skin surface) for 24 h
with occlusive patch
Lauryl
Hydroxysultaine
28% to 32% aqueous solution Dermal irritation study in 3 male
New Zealand White rabbits in
accordance with OECD TG
404; test material applied to
intact skin for 4 h with a semiocclusive
patch
Lauryl
Hydroxysultaine
0.4% aqueous solution in
intradermal exposures; 1%
aqueous solution in topical
exposures
Sensitization - Animal
Cocamidopropyl
Hydroxysultaine
42% aqueous solution;
intradermal injection was at
10% in deionized water or in
Freund's adjuvant; topical
induction and challenge was
undiluted
Sensitization - Human
Capryl Sultaine
Formulation containing .25%
Guinea pig maximization study;
study not validated
Not a skin irritant; primary
irritation score = 0; minimal
inflammation observed on test
sites
Not a skin irritant; very slight
erythema (grade 1) observed
at 1h post-patch removal in all
animals that remained in 1
animal up until 48 h; mean
scores for erythema and
edema were .22 and .00,
respectively
Not a skin irritant; very slight
erythema observed in 2 males
at the abraded and nonabraded
sites and well-defined
erythema (score 2) observed
in the female at both skin sites;
very slight edema observed in
the female only; no reactions at
72 h
Slight dermal irritant; mean score
of 1 (very slight erythema) was
reported for 2/3 animals;
duration of the reaction was
less than 7 days; mean score
for edema in all 3 animals was 0
No irritation reported; no
adequate reporting of the
induction scores, positive
controls or challenge scores;
no conclusion made on
sensitization
Guinea pig maximization test in
accordance with OECD TG
406 in 20 Pirbright guinea pigs;
occlusive patch
In-use study in human subjects
with " rough skin conditions " ;
material was applied either a
single time (n=15) or twice
daily for 4 weeks (n=9) on
intact and/or abraded skin;
subjects observed for 48
weeks following exposure
cessation
Not sensitizing; no skin reactions
observed
Reference
27
5
5
6
6
5
No adverse events were
observed
15,28
(continued)

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