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Table 2 Scores of epithelium irritation, leucocytes infiltration, vascular congestion and edeme, and vaginal irritation index obtained in three groups of New Zealand White rabbits traited vaginally during 10 days by low (1 μM; C14-LD) or high doses (20 μM; C14-HD) of zinc tetra-ascorbo-camphorate derivative (C14), or by PBS (negative controls).

From: Pre-clinical development as microbicide of zinc tetra-ascorbo-camphorate, a novel terpenoid derivative: Potent in vitro inhibitory activity against both R5- and X4-tropic HIV-1 strains without significant in vivo mucosal toxicity

  C14-HD* C14-LD* 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
  1. * Mean ± 1 standard deviation
  2. £ 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.
  3. $ 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).