Toxicological Evaluation of a Dissolvable and Disinfectant Condom in Rodents

Abstract

Background: Dissolvable and disinfectant male condoms are designed to dissolve fully in the vagina within 1–2 minutes, releasing activated elements with antimicrobial as well as spermicidal action. However, this supposed benefit might also be a source for concern, as it could make them toxic. Objectives: This study evaluates the toxicological profile of a new dissolvable and disinfectant condom using rodent toxicological models. Methods: Using standard models, we conducted acute, sixty days sub-chronic, micronuclei induction, skin sensitivity, vaginal irritation and teratological toxicity tests (doses ranging from 200 to 3200 mg/kg) on the condom sample. Results: Oral LD 50 was estimated to be >3200 mg/kg. No observed changes in biochemical and haematological parameters were observed on sub-chronic exposure; however, serum malondialdehyde (MDA) level was significantly increased at 1600 mg/kg. A significant increase in the incidence of micro-nucleated cells was observed in the micronucleus assay while no toxic effect was observed in the skin sensitivity test. Histological assessment revealed the incidence of vasculitis and fibrosis in the condom exposed vagina in the vaginal irritation test. Foetal resorption (100%) was observed in the 3200 mg/kg group in the teratological test. No incidence of growth retardation, gross malformations, histopathologi-cal, biochemical and haematological differences were observed at first filial when compared with control. Conclusion: Micronuclei induction possibly due to lipid peroxidation effects, the incidence of vagina fibrosis/vasculitis and foetal resorptions at doses lower than possible human exposure suggest some caution in the use of this product.