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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ As described in the SCCS Guidance on the Safety Assessment of Nanomaterials in Cosmetics (SCCS 1484/12), if considerable systemic exposure or genotoxicity cannot be excluded, information on carcinogenicity is required. The SCCS notes that no information has been provided on systemic availability via the relevant uptake route(s) or on genotoxicity that would allow drawing conclusions on the need for information on carcinogenicity. 3.3.9. Reproductive toxicity No information was provided. SCCS comment: As described in the SCCS Guidance on the Safety Assessment of Nanomaterials in Cosmetics (SCCS 1484/12), if considerable systemic exposure cannot be excluded, information on reproductive toxicity is required. The SCCS notes that no information has been provided on systemic availability via the relevant uptake route(s) that would allow drawing conclusions on reproductive toxicity. 3.3.10. Photo-induced toxicity No information was provided. SCCS comment: Information should be provided for those products intended to be used on skin that is exposed to sunlight. 3.3.11. Toxicokinetics No information was provided. SCCS comment: According to the SCCS Guidance on the safety assessment of nanomaterials in cosmetics (SCCS 1484/12), it is necessary to determine whether systemic absorption is possible via the relevant uptake pathway(s), in this particular case the oral and the dermal uptake route. Where tests on oral, inhalation or dermal/ percutaneous absorption show evidence for systemic absorption of nanoparticles, initial focus of toxicological investigations should be on determining Absorption, Distribution, Metabolism and Excretion (ADME) parameters to understand the fate and behaviour of nanoparticles in the body and to identify the likely target organs. The investigations should determine whether there are any changes in physicochemical characteristics of the nanoparticles, in terms of surface binding of proteins or other moieties that may have altered interaction with biological systems, and whether there are any changes in the integrity of the nanostructure, or agglomeration/ aggregation behaviour. The SCCS is well aware that literature information on the toxicokinetics of nanosilver is insufficient (see SCENIHR, 2014). Nevertheless, efforts should be undertaken to address these issues based an available information and experimental studies (see also the section on dermal absorption). Ref.: 28 27PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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