Table 5.
Summary of skin sensitization studies of cocamidopropyl betaine (CAPB)
| Subjects | Dose | Results | Refs. |
|---|---|---|---|
| Guinea pig (n = 15) |
- Induction: (1) 0.05% active CAPB (2) 6% active CAPB - Challenge: 1% active CAPB |
No evidence for delayed contact hypersensitivity | [12] |
| Guinea pig (n = 20) |
- Induction: 0.75% active CAPB - Challenge: 0.01875% CAPB |
No evidence of sensitization | [13] |
| Guinea pig/Albino(n = 20) |
- Induction: (1) 0.03% active CAPB or 0.03% active CAPB) plus the adjuvant (2) 3% active CAPB - Challenge: 3% active CAPB |
Erythema, edema, acanthosis, mild intracellular edema, lymphomononuclear infiltration (8/20) acanthosis, mild intracellular edema, a moderate lymphomononuclear infiltration (4/20) Slight acanthosis (2/20) |
[14] |
| Guinea pig (n = 20) |
- Induction: 0.15% active CAPB - Challenge: 0.015% active CAPB |
Delayed-type contact sensitization | [14] |
| Human (n = 88) |
- Open application HRIPT - 1.872% active CAPB |
No sensitization | [15] |
|
Human (n = 93) |
- Open application HRIPT - 0.93% active CAPB |
No sensitization | [16] |
|
Human (n = 100) |
- HRIPT - 0.3% active CAPB |
No sensitization | [17] |
|
Human (n = 141) |
- HRIPT - 1.5% active CAPB increased to 3.0% active |
No sensitization | [18] |
|
Human (n = 210) |
- HRIPT - 6% active CAPB |
No sensitization | [19, 20] |
|
Human (n = 27) |
- HRIPT - 0.018% active CAPB |
No sensitization | [21] |
|
Human (n = 781 or 102) |
- Patch test - 1% or 0.3% active CAPB |
56/781 positive (7.2%) 3/102 positive (3%) |
[22] |
|
Human (n = 10,798) |
- Patch test - 1% or 0.3% active CAPB |
29 positive (0.27%) | [23] |
|
Human (n = 12) |
- Patch test - CAPB % unknown |
Irritation only | [24] |
|
Human (n = 93) |
- Patch test - 1% or 0.3% active CAPB |
4 positive | [60] |
|
Human (n = 210) |
- Patch test - 1% or 0.3% active CAPB |
12 positive (5.75%) | [26] |