IJT - CIR - February 2024 - 45S

Burnett et al.
45S
Table 7. (continued)
Ingredient
Cocamidopropyl
Hydroxysultaine
Cocamidopropyl
Hydroxysultaine
Concentration/Dose
Method
4% solids
HRIPT in 51 healthy volunteers;
.2 mL applied with 1 inch
square semi-occluded patches
on the upper back
2.5% aqueous solution
HRIPT in 44 healthy volunteers;
.3 mL applied with a 20 mm2
occluded patch to the upper
arm
Lauramidopropyl
Hydroxysultaine
Lauryl
Hydroxysultaine
Formulation containing 42% test
material, diluted to a 12%
solution in distilled water; pH
adjusted to 6.03
4% solids
HRIPT in 54 healthy volunteers;
.2 mL applied with 1 inch
square semi-occluded patches
on the upper back
HRIPT in 51healthy volunteers;
.2 mL applied with 1 inch
square semi-occluded patches
on the upper back
LD50 for 42% Cocamidopropyl Hydroxysultaine was approximately
3000 mg active ingredient/kg bw in rats and
3150 mg active ingredient/kg bw in mice. The LD50 for 28%
to 32% Lauryl Hydroxysultaine was >560-640 mg/kg bw
active ingredient in rats.
In a study of 36.2% Cocamidopropyl Hydroxysultaine in
rats, the NOAEL for parental toxicity was 100 mg/kg/day
based on microscopic findings in the forestomach, lungs,
trachea and kidneys of animals given 300 mg/kg/day. This
study also evaluated the developmental and reproductive
toxicity ofthis ingredient, and a NOEL of300 mg/kg/day was
determined for both the reproductive performance of the
parental animals and for toxic effects on the pups.
Lauryl Hydroxysultaine at 29% was not mutagenic in an
Ames test. Cocamidopropyl Hydroxysultaine at up to 50%
was not genotoxic in an Ames test, a mouse lymphoma cell
mutation assay, or a chromosome aberration study in
human lymphocytes. A rat micronucleus test of 36.2% Cocamidopropyl
Hydroxysultaine found this ingredient did not
induce chromosome damage. No published carcinogenicity
studies on alkyl sultaines were identified and no unpublished
carcinogenicity data were submitted.
A formulation containing .25% Capryl Sultaine was not a
skin irritant in rabbits. No adverse effects such as irritation or
pigmentation were observed in a clinical in-use study of a
formulation containing .25% Capryl Sultaine in 24 human
subjects. Cocamidopropyl Hydroxysultaine at up to 41.5%
was not a skin irritant in rabbit studies. Lauryl Hydroxysultaine
at concentrations of28% to 32% was a slight dermal
irritant in rabbits. Cocamidopropyl Hydroxysultaine was not a
dermal sensitizer in a guinea pig maximization study where
the test animals were induced via intradermal injection at 10%
Cocamidopropyl Hydroxysultaine in deionized water or in
Freund's adjuvant and via topical application and at challenge
Results
No irritation or sensitization
observed
Not sensitizing; slight to
moderate irritation observed
in 45% of subjects after repeat
induction patches; strong
irritation reactions observed in
2 subjects
No irritation or sensitization
observed
No irritation or sensitization
observed
Reference
29
5
4
30
at 42% Cocamidopropyl Hydroxysultaine. Cocamidopropyl
Hydroxysultaine was not a dermal sensitizer in a HRIPT at
2.5%; however, slight to moderate irritation was observed
after repeated induction patches in the HRIPT. No irritation or
sensitization was observed in a HRIPT of 12% Lauramidopropyl
Hydroxysultaine. Cocamidopropyl Hydroxysultaine
(1%) yielded positive patch tests in a patient that
experienced eczema following use of 2 shampoos that contained
this ingredient.
Cocamidopropyl Hydroxysultaine (4% solids), Lauramidopropyl
Hydroxysultaine (1.25% and 4% solids), and
Lauryl Sultaine (10% and 100%) were predicted to be ocular
irritants in in vitro assays. In animal studies, Cocamidopropyl
Hydroxysultaine (at up to 41.5%) and Lauryl Sultaine (10%)
were severe and moderate ocular irritants, respectively, in
rabbit eyes. Lauryl Hydroxysultaine at 28% to 32% was irritating
to rabbit eyes.
Discussion
The sultaines are structurally related to betaines and are
sometimes referred to as sulfobetaines. Each ofthe ingredients
named in this report is a sulfopropyl quaternary ammonium
salt. The Panel noted gaps in the available safety data for some
of the alkyl sultaines in this safety assessment. Because of
structural similarities among the ingredients in the report, data
on some ofthe ingredients can be used to support the safety of
ingredients for which no data are available.
The Panel noted the lack of carcinogenicity data for these
sultaine ingredients. However, the negative results obtained in
both in vitro and in vivo genotoxicity studies alleviated any
concerns regarding the need for carcinogenicity data.
The Panel expressed concern that 3,3-dimethylaminopropylamine
(DMAPA) and analogous amines that may exist as

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