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02346_1 THE EVALUATION OF THE LOCAL TOLERANCE OF VAGINAL FORMULATIONS USING THE SLUG MUCOSAL IRRITATION TEST Dhondt, Marijke Vaginal irritation may be associated with increased susceptibility to sexually transmitted pathogens. Therefore, it is important to evaluate the local tolerance of vaginal formulations. There is a tendency to reduce, refine, and replace the use of vertebrates for pre-clinical safety studies. In this study the relevance of the slug mucosal irritation test was investigated by means of several vaginal gels. The irritation potency of the gels on the mucosal tissue was assessed by the mucus production caused by a repeated 30-minute treatment on 5 successive days. Additionally, the protein and enzyme release from the mucosa of the slugs was measured after treatment. The hydroxyethyl cellulose gel induced no irritation as was demonstrated by the low mucus production and protein release and the absence of enzyme release. Replens and K-Y jelly resulted in an increased mucus production, however no increased protein and enzyme release were detected. The nonoxynol-9 containing gels Protectaid, Gynol II, Gynol II Extra Strength, Advantage S, and Conceptrol caused a higher mucus production and an increased protein release and/or enzyme release, indicating severe irritation. The results were comparable with the findings of other studies for all the formulations except for Protectaid. It can be concluded that the slug mucosal irritation test can be used to evaluate the effects of a repeated treatment with vaginal gels. Pharm. Marijke M. M. Dhondt |
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