
C14HD*

C14LD*

PBS*


Epithelium (0–4)£

1.560 ± 1.667

0.889 ± 1.270

0

Infiltration of leucocytes (0–4)£

0.556 ± 0.880

0.444 ± 0.520

0.222 ± 0.440

Vascular congestion (0–4)£

0.444 ± 1.330

0.778 ± 1.394

0

Edeme (0–4)£

0

0

0

Vaginal irritation index (0–16)$

2.4

2.1

0.2

 * Mean ± 1 standard deviation
 £ The scores for epithelium irritation, leucocytes infiltration, vascular congestion and oedeme, were calculated as the mean of the scores estimated at the cervicovagina, midvagina and urovagina of the 3 rabbits in each group. The final score is then expressed as mean ± 1 standard deviation of 9 determinations.
 $ The mean vaginal irritation index corresponds to the addition of the scores of epithelium irritation, leucocytes infiltration, vascular congestion and edeme, as adapted from the norme "ISO 10993 standard, version 2002: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization". Interpretation of the vaginal irritation index is as follows: 0: None; 1: Minimal; 2: Mild; 3: Moderate; 4: Intense. The correlations with human irritation potential are as follows: Vaginal irritation index < 8: Acceptable; 9–10: Marginal; and ≥ 11: Unacceptable, according to Eckstein and colleagues (Eckstein et al., 1969).