Table 5.
Erythema and edema scores for skin irritation index.
| Sample | Reactions | 4 h | 24 h | 48 h | 72 h | PII | Results | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | ||||
| Saline | |||||||||||||||||||||||||||
| — | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | Nonirritant |
| Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Base | |||||||||||||||||||||||||||
| Test site | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0.0416ns | Irritation barely perceptible |
| Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Control site | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | ||
| Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Standard irritant | |||||||||||||||||||||||||||
| Test site | Erythema | 2 | 2 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 3 | 2 | 2 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 3.833∗∗∗ | Moderately irritant |
| Edema | 4 | 4 | 4 | 4 | 4 | 3 | 4 | 4 | 3 | 2 | 2 | 3 | 3 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 2 | 1 | 1 | |||
| Control site | Erythema | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Edema | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| CEO | |||||||||||||||||||||||||||
| Test site | Erythema | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 4 | 2.035∗∗∗a | Mildly irritant |
| Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Control site | Erythema | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| B5 | |||||||||||||||||||||||||||
| Test site | Erythema | 0 | 0 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0.45ns/a | Irritation barely perceptible |
| Edema | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Control site | Erythema | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Edema | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||
For erythema: 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well-defined erythema, 3 = moderate to severe erythema, and 4 = severe erythema (beet redness) to slight eschar formations.
For edema: 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well defined by definite rising), 3 = moderate edema (raised approximately 1 millimeter), and 4 = severe edema.
Evaluation of primary irritation index (PII): 0.00: no irritation, 0.04–0.99: irritation barely perceptible, 1.00–1.99: slight irritation, 2.00–2.99: mild irritation, 3.00–5.99: moderate irritation, and 6.00–8.00: severe irritation.
Data was analyzed by one-way analysis of variance (ANOVA) followed by Tukey's post hoc test. nsnon-significantly different from saline control, *** P < 0.001, when standard irritant and test control (cream base, CEO and B5) were compared with vehicle control. a P < 0.001, when B5 and CEO were compared with standard irritant.