[Study on In Vitro Chromosome Aberration Test for Nanomaterials and Medical Devices Containing Nanomaterials]

To preliminarily explore a genotoxicity test system suitable for evaluating the risk of chromosomal damage in nanomaterials and medical devices containing nanomaterials.

Polystyrene nanospheres were used as nanoscale negative controls (20 μg/mL), and nano-silver (Ag40) as nanoscale positive controls (5, 10, and 20 μg/mL). These materials were co-cultured with Chinese hamster lung (CHL) cells under metabolic activation conditions for 4 h, and under non-metabolic activation conditions for 4 h, 24 h, and 72 h. Analyze the cytotoxicity results, rate of structural and numerical chromosomal aberration. Subsequently, using DMSO and H ₂O as extraction media, the in vitro chromosome aberration test of nano-silver burn and scald patches was carried out.

Under different conditions, the concentrations of all test substances were set reasonably, polystyrene nanospheres yielded negative results. Under 24 h (-S9) condition, Ag40 yielded suspiciously positive results, while under the 72 h (-S9) condition, it yielded positive results. The test results of the H ₂O extraction group and the DMSO extraction group of the nano-silver burn patch were negative under different conditions, verifying the applicability of the test system to medical device products containing nanomaterials.

By incorporating nanoscale negative and positive controls and extending exposure durations, the in vitro chromosomal aberration test based on CHL cells was preliminarily optimized, which is suitable for detecting the potential chromosomal damage risk of nanomaterials and medical device products containing nanomaterials.