IJT - CIR - February 2024 - 37S

Burnett et al.
37S
Another supplier reported that Cocamidopropyl Hydroxysultaine
is produced by reacting dimethylaminopropylamine
with coconut oil.10 The resulting intermediate is then reacted
with a bisulfite solution, a specific chlorine containing petrochemical
compound, and water to yield the alkylamidopropyl
sultaine ingredient and sodium chloride.
Lauryl Hydroxysultaine. A supplier has reported that Lauryl
Hydroxysultaine is produced by quaternizing lauryl dimethylamine
in situ with sodium oxiran-2-ylmethanesulfonate.11
Composition/Impurities
Nitrosamines/Nitrosamides. Although N-nitroso-derivative
content has not been reported, amidopropyl sultaines comprise
secondary amides, and potentially can be nitrosated
(alkyl sultaines do not have an amide that is susceptible to
nitrosation). Of the approximately 209 nitroso-amines/amides
tested, 85% have been shown to produce cancer in
laboratory animals.12 Nitrosation can occur under physiologic
conditions.13 Depending on the nitrosating agent and the
substrate, nitrosation can occur under acidic, neutral, or alkaline
conditions. Atmospheric NO2 may also participate in
nitrosation in aqueous solution.14 Accordingly, amidopropyl
sultaines should be formulated to avoid the formation of
nitroso-amines/-amides. Additionally, materials used to
manufacture these ingredients may include amines susceptible
to N-nitrosation. Thus, manufacturers should continue to use
current good manufacturing practices (cGMPs) to limit residual
contamination of these ingredients with such N-nitrosatable
impurities.
Capryl Sultaine. A manufacturer has reported using a Capryl
Sultaine raw material with purity >98% and levels ofpropane
sultone and N,N-dimethyl decylamine that are ≤ 100 ppm and
≤ 1000 ppm, respectively.15,16
Cocamidopropyl Hydroxysultaine. A supplier has reported that
Cocamidopropyl Hydroxysultaine (raw material) contains
approximately 50% solids and typically has <2 ppm
DMAPA.17 Another supplier has reported that unreacted free
DMAPA is typically <10 ppm (<10 μg/g).18
Lauramidopropyl Hydroxysultaine. A supplier has reported that,
as a raw material, Lauramidopropyl Hydroxysultaine contains
approximately 50% solids and typically has <3 ppm
DMAPA.17
Lauryl Hydroxysultaine. Lauryl Hydroxysultaine (28% to 32%
active ingredient in an aqueous solution) is reported to contain
20 ppm heavy metals (including lead), 2 ppm arsenic, <4%
quaternary ammonium salts, <1% free amine, <14% sodium
chloride, and 50% to 57% water.6
Use
Cosmetic
The safety of the cosmetic ingredients included in this assessment
is evaluated based on data received from the US
Food and Drug Administration (FDA) and the cosmetics
industry on the expected use ofthese ingredients in cosmetics.
Use frequencies of individual ingredients in cosmetics are
collected from manufacturers and reported by cosmetic
product category in the FDAVoluntary Cosmetic Registration
Program (VCRP) database. Use concentration data are submitted
by the cosmetics industry in response to surveys,
conducted by the Personal Care Products Council (Council),
ofmaximum reported use concentrations by product category.
According to 2018 VCRP data, Cocamidopropyl Hydroxysultaine
is used in 280 formulations; the majority ofuses are in
shampoos, bath soaps and detergents (Table 3).19 Four other
sultaines are in use, with 4 or less uses reported in the VCRP.
The results of the concentration of use survey conducted in
2017 by the Council indicate Cocamidopropyl Hydroxysultaine
has the highest reported maximum concentration of use; it is
used at up to 11.5% in rinse-offproducts (skin cleansing) and up
to 2.5% in leave-on face and neck skin care products.20 Lauryl
Hydroxysultaine is used at up to 5% in rinse-offproducts (noncoloring
shampoos): there were no reported use concentrations
in leave-on products. Ingredients with no reported uses in the
VCRP or by Council are listed in Table 4.
In some cases, reports of uses were received from the
VCRP, but no concentration of use data were provided. For
example, Lauryl Sultaine is reported to be used in 2 formulations,
but no use concentration data were provided.
Some of the alkyl sultaines may be used in products that
can come into contact with mucous membranes. For example,
Cocamidopropyl Hydroxysultaine is used in bath soaps and
detergents at up to 6.8%.21 Additionally, some of the alkyl
sultaines were reported to be used in hair care products that
could possibly be inhaled. For example, Cocamidopropyl
Hydroxysultaine was reported to be used in a hair spray at a
maximum concentration of .05%. In practice, 95% to 99% of
the droplets/particles released from cosmetic sprays have
aerodynamic equivalent diameters >10 μm, with propellant
sprays yielding a greater fraction of droplets/particles below
10 μm compared with pump sprays.22-25 Therefore, most
droplets/particles incidentally inhaled from cosmetic sprays
would be deposited in the nasopharyngeal and bronchial regions
and would not be respirable (i.e., they would not enter
the lungs) to any appreciable amount.22,25
The alkyl sultaine ingredients described in this safety assessment
are not restricted from use in any way under the rules
governing cosmetic products in the European Union.26 An assessment
on Lauryl Hydroxysultaine produced by NICNAS
concluded that this ingredient was a hazard due to its serious eye
irritation potential; however, " when used [at concentrations up to

IJT - CIR - February 2024

Table of Contents for the Digital Edition of IJT - CIR - February 2024

Contents
IJT - CIR - February 2024 - Cover1
IJT - CIR - February 2024 - Cover2
IJT - CIR - February 2024 - 1S
IJT - CIR - February 2024 - 2S
IJT - CIR - February 2024 - Contents
IJT - CIR - February 2024 - 4S
IJT - CIR - February 2024 - 5S
IJT - CIR - February 2024 - 6S
IJT - CIR - February 2024 - 7S
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IJT - CIR - February 2024 - 11S
IJT - CIR - February 2024 - 12S
IJT - CIR - February 2024 - 13S
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IJT - CIR - February 2024 - 15S
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IJT - CIR - February 2024 - 19S
IJT - CIR - February 2024 - 20S
IJT - CIR - February 2024 - 21S
IJT - CIR - February 2024 - 22S
IJT - CIR - February 2024 - 23S
IJT - CIR - February 2024 - 24S
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IJT - CIR - February 2024 - 33S
IJT - CIR - February 2024 - 34S
IJT - CIR - February 2024 - 35S
IJT - CIR - February 2024 - 36S
IJT - CIR - February 2024 - 37S
IJT - CIR - February 2024 - 38S
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IJT - CIR - February 2024 - 89S
IJT - CIR - February 2024 - 90S
IJT - CIR - February 2024 - 91S
IJT - CIR - February 2024 - 92S
IJT - CIR - February 2024 - 93S
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IJT - CIR - February 2024 - 95S
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IJT - CIR - February 2024 - 101S
IJT - CIR - February 2024 - 102S
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IJT - CIR - February 2024 - 105S
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IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
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