IJT - CIR - February 2024 - 43S

Burnett et al.
43S
Table 6. (continued)
Ingredient
In Vivo
Cocamidopropyl
Hydroxysultaine
36.2% aqueous solution at 0,
30, 100, or 300 mg/kg/day
Micronucleus assay conducted as part
of the Short-Term Toxicity/DART
study described above (see
TOXICOLOGICAL STUDIES and
DEVELOPMENTAL AND
REPRODUCTIVE TOXICITY
(DART) STUDIES) in groups of 10
male and 10 female SpragueDawley
rats; another group of 5
males and 5 females received a
single dose of 30 mg/kg
cyclophosphamide (positive
control) on the day prior to the
scheduled killing of the other test
animals.
to 4 weeks.15,28 Cocamidopropyl Hydroxysultaine was not a
dermal sensitizer in a human repeated insult patch tests
(HRIPTs) at up to 4% (solids); however, slight to moderate
irritation was observed after repeated induction patches in a
HRIPT of the ingredient at 2.5%.5,29 Lauramidopropyl Hydroxysultaine
and Lauryl Hydroxysultaine did not cause
dermal irritation or sensitization in HRIPTs at 12% solution
and 4% solids, respectively.4,30
Ocular Irritation Studies
Ocular irritation studies are summarized in Table 8.4-6,31-36
Cocamidopropyl Hydroxysultaine (4% solids), Lauramidopropyl
Hydroxysultaine (1.25% and 4% solids), and
Lauryl Sultaine (10% and 100%) were predicted to be ocular
irritants in vitro assays.4,31,32,35,36 In rabbit eyes, Cocamidopropyl
Hydroxysultaine (at up to 41.5%) and Lauryl Sultaine
(10%) were severe and moderate ocular irritants,
respectively.5,31,33,34 Lauryl Hydroxysultaine at 28% to 32%
was irritating to rabbit eyes.6
Clinical Studies
Case Reports
Cocamidopropyl Hydroxysultaine. A 54-year-old man presented
with eczema of 2 month duration on the forehead, back of
neck, ears, and surrounding areas.37 He had been using 2
different shampoos that included botanical materials. A
similar reaction occurred to a massage product in the past. The
patient was patch tested with 40 screening agents and corticosteroids:
++ reactions to formaldehyde (1% aq.),
quaternium-15 (1% pet.); DMDM hydantoin (2% aq.),
methylisothiazolinone and methylchloroisothiazolinone
(.02% aq.), and Cocamidopropyl Hydroxysultaine (1% aq.)
were observed. Tests were read at days 2 and 5, and all were
The test material did not induce
damage to the chromosomes
or the mitotic apparatus of rat
bone marrow cells at doses up
to 300 mg/kg/day
5
Concentration/Dose
Method
Results
Reference
positive by the day 2 reading. Five control subjects tested with
Cocamidopropyl Hydroxysultaine were negative. Milder reactions
(+ and ?+) were also observed in the patient to cobalt
chloride (1% pet.), potassium dichromate (.5% pet.), and carba
mix (1,3-diphenylguanidine, zinc dibutyldithiocarbamate, and
zinc diethyldithiocarbamate). The patient was negative to
cocamidopropyl betaine, as well as to 33 other screening
allergens, 5 additional preservatives, and 10 topical
corticosteroids.
Summary
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 structures ofeach ofthe alkyl sultaines are relatively
similar, and certain toxicological data for one ingredient may
be informative about the toxicity of one or more of the other
ingredients in this report. According to the Dictionary, most of
the 13 alkyl sultaine ingredients detailed in this report function
as antistatic agents, surfactants, and skin and hair conditioning
agents in cosmetics.
Cocamidopropyl Hydroxysultaine is reported to be used in
280 formulations; the majority of uses are in shampoos, bath
soaps and detergents. Four other sultaines are in use, with 4 or
less uses reported in the VCRP. Cocamidopropyl Hydroxysultaine
has the highest reported maximum concentration of
use; it is used at up to 11.5% in rinse-off products (skin
cleansing) and up to 2.5% in leave-on face and neck skin care
products. Lauryl Hydroxysultaine is used at up to 5% in rinseoffproducts
(non-coloring shampoos); there were no reported
use concentrations in leave-on products reported for this
ingredient.
In acute dermal studies performed in rats, 36.2% Cocamidopropyl
Hydroxysultaine in solution had an LD50 >
2000 mg active ingredient/kg bw. In acute oral studies, the

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