IJT - CIR - February 2024 - 47S

Burnett et al.
47S
Table 8. (continued)
Ingredient
Lauryl
Hydroxysultaine
Concentration/Dose
Method
28% to 32% in an aqueous
solution
Eye irritation/corrosion study in
accordance with OECD TG 405
in 3 male New Zealand White
rabbits; eyes were not rinsed
Results
Irritant; test material produced
conjunctival irritation, corneal
opacity, and iridial inflammation in
all rabbits; one treated eye
appeared normal at day 14
observation while a second
appeared normal at day 21
observation; opacity was still
observed in the third eye on day
21.
Lauryl Sultaine
Lauryl Sultaine
diluted at 10% in minimum
essential medium
10% w/v in phosphate
buffered saline; 100 µL
Draize method in rabbits (no
further details reported
Modified Draize method in 3 albino
rabbits, sex not reported; test
material instilled in conjunctival
sac of 1 eye each
impurities in the amidopropyl hydroxysultaine ingredients
could cause sensitization. Dermal sensitization was not observed
in animal or human studies of Cocamidopropyl Hydroxysultaine
and Lauramidopropyl Hydroxysultaine, and
suppliers have reported that DMAPA impurities are at extremely
low levels (<3 ppm). The Panel noted that the
manufacturing processes for each of the amidopropyl hydroxysultaine
ingredients are generally similar and are expected
to produce the same types ofimpurities. In quantitative
risk assessments (QRAs) submitted to support the CIR safety
assessment of Cocamidopropyl Betaine and related fatty acid
amidopropyl betaines, conservative weight-of-evidence
(WoE) no expected sensitization induction levels (NESILs)
were calculated to be 425 μg/cm2 for DMAPA. Based on (1)
this NESIL, (2) the lack of reported sensitization to the
amidopropyl hydroxysultaine ingredients in the literature, and
(3) the use concentrations ofthe these ingredients, the amount
ofDMAPA present would likely be well below doses expected
to induce sensitization; however, to ensure that sensitization
does not occur in consumers, the Panel urges manufacturers to
minimize the content of DMAPA and related sensitizing
agents in cosmetic formulations.
The Panel discussed the issue of incidental inhalation
exposure in hair sprays. There were no inhalation toxicity data
available. These ingredients are reportedly used at concentrations
up to .05% in cosmetic products that may be aerosolized.
The Panel noted that 95% - 99% ofdroplets/particles
produced in cosmetic aerosols would not be respirable to any
appreciable amount. The potential for inhalation toxicity is not
limited to respirable droplets/particles deposited in the lungs.
In principle, inhaled droplets/particles deposited in the nasopharyngeal
and thoracic regions ofthe respiratory tract may
cause toxic effects depending on their chemical and other
properties. However, coupled with the small actual exposure
Moderate irritant; maximal average
score (MAS) and day 1 score each
= 39.7; reversibility of damage
after 21days
Irritant; MAS = 43.7
Reference
6
31
34
in the breathing zone and the concentrations at which the
ingredients are used, the available information indicates that
incidental inhalation would not be a significant route of exposure
that might lead to local respiratory or systemic effects.
A detailed discussion and summary ofthe Panel's approach to
evaluating incidental inhalation exposures to ingredients in
cosmetic products is available at https://www.cir-safety.org/
cir-findings.
In past ingredient safety assessments, the Panel had expressed
concern over N-nitrosation reactions in ingredients
containing amine/amide groups. Cocamidopropyl Hydroxysultaine
and the other alkylamidopropyl sultaine ingredients
in this assessment contain secondary amides that may serves
as substrates for N-nitrosation. Additionally, these ingredients
may contain secondary/tertiary amine impurities which may
serves as substrates for N-nitrosation. Therefore, the Panel
recommended that alkylamidopropyl sultaines should not be
used in cosmetic products in which N-nitroso compounds can
be formed, and manufacturers should continue to use cGMPs
to limit N-nitrosatable impurities in both, alkylamidopropyl
sultaines and alkyl sultaines.
The Panel also expressed concern regarding pesticide
residues, heavy metals, and other plant species that may be
present in botanical ingredients. They stressed that the cosmetics
industry should continue to use cGMPs to limit
impurities.
The Panel considered the risks inherent in using animalderived
ingredients, namely the transmission of infectious
agents. Although tallow may be used in the manufacture of
Tallowamidopropyl Hydroxysultaine in this safety assessment
and is clearly animal derived, the Panel noted that tallow is highly
processed, and tallowderivatives evenmore so. The Panel agreed
with determinations by the U.S. FDA that tallow derivatives are
not risk material for transmission of infectious agents.
https://www.cir-safety.org/cir-findings https://www.cir-safety.org/cir-findings

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
IJT - CIR - February 2024 - 8S
IJT - CIR - February 2024 - 9S
IJT - CIR - February 2024 - 10S
IJT - CIR - February 2024 - 11S
IJT - CIR - February 2024 - 12S
IJT - CIR - February 2024 - 13S
IJT - CIR - February 2024 - 14S
IJT - CIR - February 2024 - 15S
IJT - CIR - February 2024 - 16S
IJT - CIR - February 2024 - 17S
IJT - CIR - February 2024 - 18S
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
IJT - CIR - February 2024 - 25S
IJT - CIR - February 2024 - 26S
IJT - CIR - February 2024 - 27S
IJT - CIR - February 2024 - 28S
IJT - CIR - February 2024 - 29S
IJT - CIR - February 2024 - 30S
IJT - CIR - February 2024 - 31S
IJT - CIR - February 2024 - 32S
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
IJT - CIR - February 2024 - 39S
IJT - CIR - February 2024 - 40S
IJT - CIR - February 2024 - 41S
IJT - CIR - February 2024 - 42S
IJT - CIR - February 2024 - 43S
IJT - CIR - February 2024 - 44S
IJT - CIR - February 2024 - 45S
IJT - CIR - February 2024 - 46S
IJT - CIR - February 2024 - 47S
IJT - CIR - February 2024 - 48S
IJT - CIR - February 2024 - 49S
IJT - CIR - February 2024 - 50S
IJT - CIR - February 2024 - 51S
IJT - CIR - February 2024 - 52S
IJT - CIR - February 2024 - 53S
IJT - CIR - February 2024 - 54S
IJT - CIR - February 2024 - 55S
IJT - CIR - February 2024 - 56S
IJT - CIR - February 2024 - 57S
IJT - CIR - February 2024 - 58S
IJT - CIR - February 2024 - 59S
IJT - CIR - February 2024 - 60S
IJT - CIR - February 2024 - 61S
IJT - CIR - February 2024 - 62S
IJT - CIR - February 2024 - 63S
IJT - CIR - February 2024 - 64S
IJT - CIR - February 2024 - 65S
IJT - CIR - February 2024 - 66S
IJT - CIR - February 2024 - 67S
IJT - CIR - February 2024 - 68S
IJT - CIR - February 2024 - 69S
IJT - CIR - February 2024 - 70S
IJT - CIR - February 2024 - 71S
IJT - CIR - February 2024 - 72S
IJT - CIR - February 2024 - 73S
IJT - CIR - February 2024 - 74S
IJT - CIR - February 2024 - 75S
IJT - CIR - February 2024 - 76S
IJT - CIR - February 2024 - 77S
IJT - CIR - February 2024 - 78S
IJT - CIR - February 2024 - 79S
IJT - CIR - February 2024 - 80S
IJT - CIR - February 2024 - 81S
IJT - CIR - February 2024 - 82S
IJT - CIR - February 2024 - 83S
IJT - CIR - February 2024 - 84S
IJT - CIR - February 2024 - 85S
IJT - CIR - February 2024 - 86S
IJT - CIR - February 2024 - 87S
IJT - CIR - February 2024 - 88S
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
IJT - CIR - February 2024 - 94S
IJT - CIR - February 2024 - 95S
IJT - CIR - February 2024 - 96S
IJT - CIR - February 2024 - 97S
IJT - CIR - February 2024 - 98S
IJT - CIR - February 2024 - 99S
IJT - CIR - February 2024 - 100S
IJT - CIR - February 2024 - 101S
IJT - CIR - February 2024 - 102S
IJT - CIR - February 2024 - 103S
IJT - CIR - February 2024 - 104S
IJT - CIR - February 2024 - 105S
IJT - CIR - February 2024 - 106S
IJT - CIR - February 2024 - 107S
IJT - CIR - February 2024 - 108S
IJT - CIR - February 2024 - 109S
IJT - CIR - February 2024 - 110S
IJT - CIR - February 2024 - 111S
IJT - CIR - February 2024 - 112S
IJT - CIR - February 2024 - 113S
IJT - CIR - February 2024 - 114S
IJT - CIR - February 2024 - 115S
IJT - CIR - February 2024 - 116S
IJT - CIR - February 2024 - 117S
IJT - CIR - February 2024 - 118S
IJT - CIR - February 2024 - Cover3
IJT - CIR - February 2024 - Cover4
https://www.nxtbookmedia.com