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. 2024 May 21;40(3):361–375. doi: 10.1007/s43188-024-00243-2

Table 3.

Summary of eye irritation studies of cocamidopropyl betaine (CAPB)

Subjects Dose Results Refs.
Albino Rabbit (n = 3/group) 4.5% active CAPB, 0.1 mL

Unrinsed eyes: slight conjunctival erythema and chemosis in all 3 eyes

Rinsed eyes: very slight conjunctival irritation in 2 of 3 eyes

[39]

Albino Rabbit

(n = 3)

30% active CAPB, 0.1 mL

Mild conjunctival erythema, chemosis, and discharge

Diffuse corneal opacity

Slight iritis

[40]
Albino Rabbit (n = 3) 6% active CAPB, 0.1 mL Mild conjunctival erythema and slight discharge [41]
New Zealand White Rabbit (n = 6) 7.5% active CAPB (pH 8.3), 0.1 mL

Mild-to-moderate conjunctival irritation

Moderate corneal opacity in 1 eye

[42]
Albino Rabbit (n = 1) 10% active CAPB (pH 6.1), 0.1 mL Draize score 28 after day 1, 25 after day 2, 30 after day 3, 14 after day 4, 7 after day 7 [43]
New Zealand White Rabbit (unrinsed: n = 6; rinsed: n = 3) 30% active CAPB, 0.1 mL

Unrinsed eyes: corrosive (corneal opacity, slight iritis, conjunctival irritation, necrosis), mean eye irritation score 32.5 ± 4.4 after 24 h, 31.7 ± 3.3 after 48 h, 41.7 ± 11.7 after 72 h, 27.2 ± 11.4 after 7 days (scale 0–110)

Rinsed eyes: minimal irritation (mean score = 10.0 + 2.0 after 24 h)

[44]
New Zealand White Rabbit (n = 9) 10% active CAPB, 0.1 mL

Unrinsed eyes: moderately irritating, mean eye irritation scores 25.7 ± 8.3 after 24 h, 16.7 ± 10.9 after 48 h, 9.3 ± 11.4 after 72 h, 0 by day 7

Rinsed eyes: nonirritating, mean score of 2.0 ± 2.0 after 24 h, 0 by 48 h

[45]
New Zealand White Rabbit (n = 6) 5% CAPB, 0.1 mL

Not an irritant

Draize score = 4.90

[46]
New Zealand White Rabbit (n = 6) 10% CAPB, 0.1 mL

Moderately irritating

Draize score = 27.3

[48]
Albino Rabbit (n = 6) 3.0% active CAPB

Corneal irritation scores: 0 on days 1 and 2, 1.66 on days 3 and 4, 4.16 on day 7 (max. score = 80)

Iritis score: 8.33 on day 1, 4.16 by day 7 (scale 0–10)

Conjunctival irritation score: 15.37 (scale 0–20), 6 by day 7

[49]
Albino Rabbit (n = 6) 3.0% active CAPB

No corneal irritation

Iritis score: 5 on day 1, 0 by day 7 (scale 0–10)

Conjunctival irritation score: 14.33 (scale 0–20), 0 by day 7

[49]
Albino Rabbit (n = 6) 3.0% active CAPB, 0.1 mL

An eye irritant

Mean ocular index: 41.6 (max. 110)

[50, 51]
New Zealand White Rabbit (unrinsed: n = 6; rinsed: n = 3) Soap formulation containing 2.3% active CAPB, 0.1 mL

Moderately irritating to iris and conjunctiva

Unrinsed eyes: average irritation score = 18.7

Rinsed eyes: average irritation score = 20.0

[52]
New Zealand White Rabbit (unrinsed: n = 6; rinsed: n = 3) Soap formulation containing 2.3% active CAPB

Unrinsed eyes: minimally irritating, average irritation score = 1.7 (max. 110)

Rinsed eyes: mildly irritating, average irritation score = 3.3

[53]
New Zealand White Rabbit (n = 4, rinsed) Soap formulation containing 6.5% active CAPB, 0.1 mL

Moderately irritating

Mean corneal irritation score: 13.8, 18.8, 11.3, 5, 1.3 after 1 h, 24 h, 48 h, 72 h, and 7 days (max. 80)

Mean iridial irritation score: 3.8 after 1 and 24 h, declining to 0 after 7 days

Mean conjunctival irritation score: 11, 7.5, 4, 3.5, 2 after 1 h, 24 h, 48 h, 72 h, and 7 days

Total mean irritation score = 30.0 (max. 110)

[54]
Albino Rabbit (n = 6) Formulation containing 6.0% active CAPB, 0.1 mL

Conjunctival irritation: mean score 4 (max. 20) after day 1

No corneal irritation or iritis

[10]