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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ - It is not clear to the SCCS why an ISO guideline for testing medical devices was followed, while cosmetic ingredients should be tested using OECD TG test guidelines or EU methods (See SCCS 1484/12) - L929 fibroblasts are not suggested in OECD TG 487: the choice of the cell line was not justified - No data on positive control substances are given (concentrations, vehicles, etc.) - No data have been provided which are necessary to demonstrate that the cells in culture have divided, so that a substantial proportion of the cells scored have undergone division during or following treatment with the test chemical. The measurement of Relative Population Doubling (RPD) or Relative Increase in Cell Count (RICC) is recommended to estimate the cytotoxic and cytostatic activity of a treatment – apparently no such parameters were assessed. - In the study only one concentration has been evaluated (10 ppm). At least three test concentrations (not including the solvent and positive controls) that meet the acceptability criteria (appropriate cytotoxicity, number of cells, etc.) should be evaluated. - A cytotoxic effect of the test item was observed after 6 or 30 h of exposure in the absence of S9-mix, but of unknown value. Due to this reason, further testing in the absence of S9-mix was not performed. No data on cell viability after exposure to the test item in the presence of S9-mix were provided. According to OECD TG 487, the highest concentration should aim to achieve 55 ± 5% cytotoxicity, using the recommended cytotoxicity parameters (which were not evaluated at all in the study). Mutagenicity/genotoxicity data from in vitro studies would be required for all colloidal silver dispersions as part of the base set requirements for assessment of cosmetic products (including proper material characterisation). Any existing data from in vivo studies (conducted prior to 11 March 2013) with relevant, well-characterised materials should also be provided. In a previous Opinion (SCCS/1577/16), the SCCS noted that mutagenicity/genotoxicity data on silver nanoparticles were inconclusive. Ref.: 34 3.3.8. Carcinogenicity One Applicant (reference 18) stated that there is no effect on carcinogenicity citing reports from the American Conference of Governmental Industrial Hygienists (ACGIH), the International Agency on Research on Cancer (IARC) and the National Toxicology Program (NTP). Another Applicant stated that carcinogenicity classification was not possible from current data. However, tumours at site of application were reported. Ref.: 13, 15, 18 Additional data Additional data on colloidal silver dispersion A state that carcinogenic effects have not been reported (without any underlying experimental data). Also, according to the Applicant of dispersion A, the product is not classified in the CMR categories 1A, 1B, and 2. Ref.: 41, 42 SCCS comment: No proper data or studies performed were provided. Incomplete citations to reports of the ACGIH, IARC and NTP were used, without stating the year of publication. This information should be provided. Furthermore, the Applicants did not substantiate the statements made (“Classification not possible from current data” and “Tumours at site of application”) by sound data. 26PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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