IJT - CIR - February 2024 - 42S

42S
International Journal of Toxicology 43(Supplement 1)
Table 6. Genotoxicity Studies.
Ingredient
In Vitro
Lauryl
Hydroxysultaine
Cocamidopropyl
Hydroxysultaine
Cocamidopropyl
Hydroxysultaine
Concentration/Dose
Method
29% aqueous solution at up
to 1000 µg/plate with
metabolic activation and
up to 100 µg/plate without
metabolic activation
50% aqueous solution at up
to 20 µL/plate, with and
without metabolic
activation
36.2% aqueous solution at up
to 200 µg/mL without
metabolic activation and
up to 400 µg/mL with
metabolic activation
Ames test in Salmonella typhimurium
strains TA1538, TA1535, TA1537,
TA98, TA100 and Escherichia coli
strain WP2uvrA
Ames test in S. typhimurium strains
TA1535, TA1537, TA1538, TA98,
and TA100
Mouse lymphoma cell mutation assay
in accordance with OECD TG 476;
2 independent experiments
performed using L5178Y TK +/mouse
lymphoma cells; in first
experiment, cells were exposed to
test material at concentrations up
to 200 µg/mL for 3 h without
metabolic activation and up to 400
µg/mL with metabolic activation; in
second experiment, the cells were
exposed to test material at up to
100 µg/mL without metabolic
activation for 24 h and up to 200
µg/mL with metabolic activation for
3h
Cocamidopropyl
Hydroxysultaine
36.2% aqueous solution at up
to 600 µg/mL without
metabolic activation and
up to 300 µg/mL with
metabolic activation
Chromosome aberrations study with
cultured human lymphocytes in
accordance with OECD TG 473;
study conducted as 2 independent
experiments; without metabolic
activation, cells were exposed to
the test substance for 3
(experiment 1), 20 or 44 h
(experiment 2), whereas with
metabolic activation the treatment
period was of 3 h in both
experiments; in experiment 1
without metabolic activation and in
both experiments with metabolic
activation, cells were rinsed after
the 3 h of treatment with the test
substance and placed in fresh
medium culture until the harvest
time; cells were harvested 20 or
44 h after the beginning of the
experiment
Results
Not mutagenic
Reference
6
Not mutagenic
5
Not mutagenic; cytotoxicity
observed at higher
concentrations
5
Cocamidopropyl
Hydroxysultaine did not
induce structural
chromosome aberrations with
and without metabolic
activation at any treatment
time; however, in the second
experiment, increases in the
numerical aberrations were
noted when compared to the
vehicle control cultures; the
numerical aberrations
exclusively consisted of
polyploidy; no dose-response
relationship or consistency
between cell cultures;
treatment-related cytotoxicity
was observed
5
(continued)

IJT - CIR - February 2024

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