IJT - CIR - February 2024 - 40S

40S
International Journal of Toxicology 43(Supplement 1)
Table 5. Acute Toxicity Studies.
Ingredient and
Concentration
Dermal
36.2%
Cocamidopropyl
Hydroxysultaine in
solution
Oral
42% Cocamidopropyl
Hydroxysultaine in
aqueous solution
1000, 2000, or 3000 mg
active ingredient/kg bw
via gavage in 3 groups of5
Wistar rats per sex
Mortalities in 2/5 females in the 2000 Female rats = 3020 mg active
mg/kg and 3000 mg/kg dose groups
and in 3/5 males in the 3000 mg/kg
dose group; hemorrhagic and lytic
mucous membrane alterations in
the gastrointestinal tract were
considered treatment-related in
rats that died post-dosing; clinical
signs in the 3000 mg/kg dose group
included reduced activity, diarrhea,
squatting, piloerection and/or
reduced skin turgor; body weight
gains were normal and no test
material-related findings at
necropsy in surviving animals.
41.5%
Cocamidopropyl
Hydroxysultaine in
aqueous solution
42% Cocamidopropyl
Hydroxysultaine in
aqueous solution
28%-32% Lauryl
Hydroxysultaine in
aqueous solution
830 mg active ingredient/kg
bw via gavage in 1 group
of 5 Wistar rats per sex
6.0, 7.5, or 10 mL/kg bw via
gavage in 3 groups of 10
CFW mice
No mortalities; slightly soft feces
observed on dosing day; no other
clinical signs; no effects in body
weight gains and no relevant
findings at necropsy.
2 mice in the low dose group, 5 mice
in the mid-dose group, and 8 mice
in the high dose group died during
the 5-day observation period;
clinical signs of toxicity not
reported; necropsy not performed
2000 mg/kg bw in 5 Wistar
Crl: (WI) BR rats per sex
No mortalities observed; no signs of
systemic toxicity; no abnormalities
at necropsy; body weight gains
were as expected
weights and feed consumption were recorded weekly until
mating and then at designated intervals throughout gestation
and post-partum. The animals were paired for mating after
2 weeks of treatment and the dams were allowed to litter and
care for the pups until day 5 post-partum (see the Developmental
and Reproductive Toxicity (Dart) Studies Section for
reproductive findings).
Prior to killing, blood samples were taken for analysis of
blood biochemistry parameters and hematology. The male rats
were killed at the end of the mating period and the dams were
killed on day 6 post-partum. Body weights and selected organs
weights were recorded and a complete macroscopic postmortem
examination including the reproductive organs was
performed. The femur of 5 animals in groups 1 to 4 and all
group 5 animals were sampled for bone marrow micronucleus
ingredient/kg bw; both sexes
= 2950 mg active ingredient/
kg bw; male rats = not
determined because deaths
only in high-dose group.
5
Dose/Study Protocol
2000 mg active ingredient/
kg bw under semiocclusive
patch for 24 h
in 1 group of 5 SpragueDawley
rats per sex
Results
No mortalities or clinical signs of
toxicity; very slight or well-defined
erythema noted at dose site in 2
females on day 2; mean body weight
gains slightly lower than historic
controls in females only
LD50
> 2000 mg active ingredient/kg
bw
Reference
5
> 830 mg active ingredient/kg bw
for both sexes
5
7.8 mL/kg bw; equivalent to
3150 mg active ingredient/kg
bw
5
> 2000 mg/kg bw for aqueous
solution; 560-640 mg/kg bw
for the active ingredient
6
analysis (see Genotoxicity - In Vivo Section). A microscopic
examination was also conducted on selected organs from the
first five animals in the control groups and the high-dose
groups. Microscopic examination was conducted on all
macroscopic lesions from all groups. Based upon the microscopic
results of the high-dose group, stomach, forestomach,
kidneys, lungs and trachea of the first five animals of
the low- and mid-dose groups were also examined.
There were no mortalities before the terminal killings in the
0, 30 and 100 mg/kg/day groups. In the 300 mg/kg/day group,
one male was found dead on day 34. At necropsy, there was an
enlargement of the lungs (with presence of red discoloration)
and white discoloration and an irregular surface of the wall of
stomach. The cause of death was moderate subacute bronchoalveolar
inflammation, most likely secondary to aspiration

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