[Investigation of the Biosafety of Commercially Available Natural Rubber Latex and Synthetic Polyurethane Condom Materials].

Objective: To investigate the biological safety of commercially available natural rubber latex and synthetic polyurethane condoms.

Methods: Natural rubber latex condom brands of A1 and A2 and polyurethane condom brands of B1 and B2 were purchased from large chain pharmacies in Chengdu, with three packages randomly selected for each brand. The study assessed the toxic effects of condom extracts on L-929 mouse fibroblasts according to GB/T standards. Gross observation and histopathological evaluation were conducted to assess the irritation reactions of condoms on the vagina and penis of rabbits (3 rabbits were used for each brand), as well as their sensitization effects on guinea pig skin. Additionally, the impact of continuous perfusion of condom extracts of the vaginas of SD rats for 30 days on their reproductive systems was evaluated, following GB/T standards (5 rats were used for each brand).

Results: Extracts from natural rubber latex condom brands A1 and A2, at concentrations of 100% and 50%, exhibited significant cytotoxicity, with optical density (OD) values being significantly lower than those of the blank control group and the polyurethane condom brands B1 and B2 (P<0.01). There was no significant difference in cell morphology and OD values between the extracts of B1 and B2 and the blank control group (P>0.05). Vaginal congestion was found in 3 rabbits from A1 group and 1 rabbit from the A2 group, while no obvious congestion was noted in rabbits from the B1 and the B2 groups. Histopathological examination showed scattered inflammatory cell infiltration in the vaginal tissue of 3 rabbits from the A1 group and 2 rabbits from the A2 group, and slight congestion in the blood vessels of the lamina propria. No obvious pathological changes were observed in the vaginal tissue of polyurethane brand rabbits. Two rabbits from the A1 group and 1 rabbit from the A2 group showed transient and mild erythema on the penis during the experiment. Histopathological examination showed that 1 rabbit from A1 group had small foci of pericapillary lymphocytes in the dermis of the penis, while no significant pathological changes were observed in the penile tissue of A2, B1, and B2 groups. After 30 days of continuous vaginal perfusion with condom extract, 3 rats in A1 group and 2 rats in the A2 group had uterine congestion, with the degree of congestion being lower in the A2 group. No significant congestion or pathological changes were observed in the vaginal and penile tissues of rabbits, or in the uterine tissues of rats from the polyurethane groups. None of the 4 groups of guinea pigs showed significant skin allergic reactions to the condom extracts.

Conclusion: Significant differences in biosafety exist among condoms of various materials and brands. To ensure product safety, it is crucial to strengthen quality control and regulatory oversight after condoms become commercially available.