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] |