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. 2015 Aug 8;17(2):482–492. doi: 10.1208/s12249-015-0378-x

Table IV.

Erythema and edema scores of skin irritation test on rabbits

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 Non-irritant
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 1 0 1 1 1 1 0 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0.083 Irritation barely perceptible
Edema 0 1 0 0 0 1 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
Control site Erythema 0 1 1 1 0 1 1 0 0 0 0 0 0 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

Positive

control

 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*,** Moderate 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
MVO Test site Erythema 1 1 1 1 1 1 2 2 2 3 2 3 4 4 4 4 4 4 3 4 3 4 4 3 2.54*,**,*** Mild 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 1 0 0 0 0 0 0 0
Edema 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
F1 Test site Erythema 1 1 1 2 1 1 2 2 2 1 2 2 3 4 3 4 3 4 2 3 2 3 2 2 2.125*,**,*** Mild irritant
Edema 1 0 0 0 1 0 1 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0
Control site Erythema 1 0 0 1 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
Edema 1 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
F2 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 0.375***,†,‡ Irritation barely perceptible
Edema 0 0 2 0 0 0 1 0 1 1 0 0 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 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Erythema 0: no erythema, 1: very slight erythema (barely perceptible), 2: well-defined erythema, 3: moderate to severe erythema, 4: severe erythema (beet redness) to slight eschar formations.Edema 0: no edema, 1: very slight edema (barely perceptible), 2: slight edema (edges of area well defined by definite raising), 3: moderate edema (raised approximately 1 mm), 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, 6.00–8.00: severe irritation

F1 MVO in ointment base, F2 microencapsulated MVO in ointment base, MVO Mentha spicata L. var. viridis oil, PII primary irritation index

Data are analyzed by one-way analysis of variance (ANOVA) followed by Tukey’s post hoc test. *p < 0.001, when compared with saline; **p < 0.001, when compared with base; ***p < 0.001, when compared with positive control; † p < 0.001, when compared with MVO; ‡ p < 0.001, when compared with F1