IJT - CIR - February 2024 - 41S

Burnett et al.
41S
ofthe test material after regurgitation at dosing. This mortality
was not considered incidental, but attributed to the test item.
Clinical signs of toxicity in the 300 mg/kg/day dose group
included loud breathing during days 17 to 19 in one male,
during all the pregnancy period in one female, and at the end of
the lactation period in another female. Hypersalivation, observed
in most animals in the 300 mg/kg/day dose group, was
considered to be treatment-related but of minor toxicological
importance. No treatment-related effects on mean body weight
or mean body weight gain were observed in the male rats. No
treatment-related effects were observed on hematological or
blood biochemistry parameters.
No treatment-related effects were observed with organ
weight or macroscopic examinations. In the 300 mg/kg/day
dose group, microscopic changes were observed in the
stomach, lungs, trachea and kidneys. Squamous cell hyperplasia
observed in the forestomach was attributed to the irritant
properties of the test item. Pulmonary bronchoalveolar inflammation
and tracheal epithelial alteration were thought to
be related to aspiration of compound after regurgitation at
dosing. Minimal to slight degeneration/hypertrophy of the
tubular epithelium was observed in the kidneys of the male
rats, while minimal tubular vacuolation was observed in some
females. In the 100 mg/kg/day dose group, a minimal epithelial
alteration in the trachea in a single male rat was not
considered an adverse effect because ofthe low incidence and
magnitude. There were no microscopic findings in the
stomach, forestomach, kidneys or lungs in this dose group.
The authors concluded that the no-observed-adverse-effectlevel
(NOAEL) for 36.2% Cocamidopropyl Hydroxysultaine
was 100 mg/kg/day based on microscopic findings in the
forestomach, lungs, trachea and kidneys of animals given
300 mg/kg/day.5
Developmental and Reproductive Toxicity
(DART) Studies
Cocamidopropyl Hydroxysultaine
The potential DART effects of 36.2% Cocamidopropyl Hydroxysultaine
in aqueous solution were assessed in the shortterm
toxicity test described above (see Toxicological
Studies - Short-Term Toxicity Studies Section above), performed
in accordance with OECD TG 422.5 The total litter
sizes and numbers of pups of each sex were recorded. The
pups were observed daily for clinical signs of toxicity. Pup
body weights were recorded on days 1 and 3 post-partum.
Pups, including those found dead before study termination,
were submitted for a macroscopic post-mortem examination.
No treatment-related effects on mating and fertility or
unscheduled mortalities were observed. All animals mated
within comparable mean number of days. Treatment-related
body weight changes in the female rats included a dose-related
decrease in mean body weight gain during the premating
period and decreases in mean body weights during the
pregnancy and lactation periods, which was associated with a
non-statistically significant decrease in mean body weight
gain during the lactation period. There were no effects on
mean feed consumption in the parental animals during any
period of the study. There were no relevant differences between
control and treatment groups in the following parameters:
mean duration of gestation, mean number of corpora
lutea, mean number of implantations, mean number of pups
delivered, mean pre-implantation loss and mean postimplantation
loss. No treatment-related effects were observed
in live births, sex-ratio, viability, or lactation indices.
No treatment-related clinical signs of toxicity were observed
in the pups. There were no significant effects on mean body
weight gains in the pups during the post-partum period. No
treatment-related findings were observed at necropsy in pups
found dead during the observation period or at study end. The
authors of this study of 36.2% Cocamidopropyl Hydroxysultaine
concluded that the no-observed-effect-level (NOEL)
for the reproductive performance of the parental animals was
300 mg/kg/day, which was also the NOEL for toxic effects on
the pups.5
Genotoxicity
In vitro and in vivo genotoxicity studies are summarized in
Table 6. Lauryl Hydroxysultaine at 29% was not mutagenic in
an Ames test.6 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.5 A rat micronucleus test of 36.2% Cocamidopropyl
Hydroxysultaine found this ingredient did not
induce chromosome damage.5
Carcinogenicity
No published carcinogenicity studies on alkyl sultaines were
discovered and no unpublished carcinogenicity data were
submitted.
Dermal Irritation and Sensitization Studies
Dermal irritation and sensitization studies are summarized in
Table 7. A formulation containing .25% Capryl Sultaine was
not a skin irritant in rabbits.27 Cocamidopropyl Hydroxysultaine
was not a skin irritant in rabbits when tested at
concentration up to 41.5%.5 Lauryl Hydroxysultaine was
slightly irritating to the skin at concentrations up to 32% in
rabbits.6 Cocamidopropyl Hydroxysultaine was not a dermal
sensitizer in a guinea pig maximization study in which 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
at 42% Cocamidopropyl Hydroxysultaine.5 No adverse effects
were observed in a clinical in-use study of a formulation
containing .25% Capryl Sultaine in 24 human subjects for up

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