IJT - CIR - February 2024 - 46S

46S
International Journal of Toxicology 43(Supplement 1)
Table 8. Ocular Irritation Studies.
Ingredient
In Vitro
Cocamidopropyl
Hydroxysultaine
Lauramidopropyl
Hydroxysultaine
Lauramidopropyl
Hydroxysultaine
Lauryl Sultaine
Lauryl Sultaine
Animal
Cocamidopropyl
Hydroxysultaine
41.5% aqueous solution;
test volume = .1 mL
Eye irritation/corrosion study in
accordance with OECD TG 405
in 3 male New Zealand White
rabbits; test material instilled in
the conjunctival sac of the right
eye of each and untreated eye
was the control
Severe eye irritant; grade 2 to grade
3 hyperemia and grade 2 to grade
3 edema, redness of the bulbar
conjunctivae, lacrimation, and
congestion and injection of the iris
observed within 1 h; reactions
observed up to 72h post-dosing;
some corneal and conjunctival
abnormalities persisted up to
14days post-dosing, with
conjunctival chemosis observed in
1 rabbit up until 21 days postdosing
Cocamidopropyl
Hydroxysultaine
Aqueous
10% solids
solution of pH 7.0; test
volume = .1 mL
Eye irritation/corrosion study in
accordance with 16 CFR §
1500.42 in 3 New Zealand
White rabbits; test material
instilled in the conjunctival sac of
the right eye of each and the
untreated eye was the control;
eyes were not rinsed
Cocamidopropyl
Hydroxysultaine
Aqueous 16% solids
solution of pH 7.0; test
volume = .1 mL
Eye irritation/corrosion study in
accordance with 16 CFR §
1500.42 in 3 New Zealand
White rabbits; test material
instilled in the conjunctival sac of
the right eye of each and the
untreated eye was the control;
eyes were not rinsed
Severe eye irritant; corneal opacity
(score 2) observed at 24h in all
rabbits and persisted up to day 7
in 1 rabbit; iridial changes
observed at 24h and persisted up
to day 4 in rabbit; conjunctival
irritation observed through day 7
in 2 rabbits with decreasing
intensity; conjunctival discharge
observed in all animals
Severe eye irritant; corneal opacity
(score 2) observed at 24h in all
rabbits and persisted up to day 7
in 1 rabbit; iridial changes
observed in 2 animals and
persisted up to day 7 in 1 rabbit;
conjunctival redness (score 2 to
3) observed at 24h and persisted
until day 7 in 1 rabbit and day 4 in
2 rabbits; chemosis observed with
varying intensity in each animal
through day 7; conjunctival
discharge observed in all animals
at 24 and 48h, decreasing in
intensity thereafter
5
4% solids in distilled water;
test dosage = .3 mL or .3
g
4% solids; test article at
100% was diluted to 20%
in distilled water; test
volume = 100 µL
42% in a formulation that
was diluted to 1.25%
diluted at 10% in minimum
essential medium; test
volume = .75 mL
100%
HET-CAM assay
MatTek EpiOcular™ tissue model;
test article at 100% was diluted
to 20% in distilled water
HET-CAM assay
validation of the BCOP assay in 12
separate laboratories
validation of the HET-CAM assay in
3 independent assays
Predicted to be moderately irritating
Predicted to be mildly irritating
Predicted to be moderately irritating
as diluted solution; predicted to
be severely irritating undiluted
Predicted to be severely irritating;
mean score = 80.6
Predicted to be irritating; mean
score = 8.3
35
36
Concentration/Dose
Method
Results
Reference
4
31
32
5
5,33
(continued)

IJT - CIR - February 2024

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IJT - CIR - February 2024 - Cover3
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