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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ The SCCS is aware that information on repeated dose-toxicity for nano silver is available from the published literature. However, it is not clear how far the materials considered in these studies are representative for the materials of this submission in terms of characterisation. 3.3.7. Mutagenicity / Genotoxicity One reference (18) states that no effect on genotoxicity has been shown, without describing any experimental results or study design. Furthermore, no data on mutagenicity/ genotoxicity have been provided. Ref.: 18 Additional information Additional information has been provided for colloidal silver dispersion A, which states that the dispersion does not show mutagenic information on reproductive cells (without any experimental evidence). Ref.: 42 Other additional information is provided for colloidal silver dispersion J. Both a cytotoxicity test in vitro (agar diffusion) and a genotoxicity test (micronucleus test) have been performed (Table 6). Table 6: Design and summary of the results of the cytotoxicity and genotoxicity tests for colloidal silver dispersion J: For both cytotoxicity and genotoxicity testing, the mouse fibroblasts cells NCTC clone 929 ATCC was tested. Detailed results of the genotoxicity study are presented in Table 7. Table 7: Detailed results of the genotoxicity test (given as % of binucleated cells with micronuclei in population of binucleated cells): 24PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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