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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ surface moieties, doping material, or encapsulating materials, and dispersing agents, other additives or formulants, e.g. stabilisers used in the formulation Data on solubility and dissolution rates of the nanomaterial in relevant solvents Additional information on physicochemical characterisation, such as melting and boiling temperature (for the silver nanomaterial in the dispersion), density, viscosity of liquid dispersions, pH, conductivity, turbidity and colour UV absorption (extinction coefficient), light reflection of typical suspensions Information on redox potential, including documentation of the conditions under which the redox potential was measured For all materials, information on primary and secondary particle size, particle number size distribution and particle mass size distribution For this, it is recommended to document the measurement method for determining size, and to use more than one method (one being electron microscopy based imaging) for determination of size parameters Data on the physical form and crystalline phase/shape. The information should indicate whether the nanomaterial is present in a particle-, tube-, rod- shape, crystal or amorphous form and also whether the nanomaterial is in the form of primary particulates or agglomerates/ aggregates Detailed information on the nanomaterial surface characteristics for all of the colloidal silver dispersions. This should include information on surface charge (zeta potential), morphology/topography, interfacial tension, reactive sites (if any), as well as any chemical/ biochemical modifications that could change the surface reactivity or add a new functionality Information on the BET specific surface area of the nanomaterial and the volume specific surface area (VSSA) for all materials (see Kreyling et al., 2010 for calculation of VSSA) Data on stability/dissociation constant of the nanomaterial in relevant formulation/ media Data on photo-catalytic activity for applications intended for use on the skin exposed to sunlight Product specifications and any batch-to-batch variation during manufacturing In spite of the fact that additional data have been provided for some colloidal silver dispersions, SCCS is of the opinion that it is still insufficient for a proper characterisation of all colloidal silver dispersions submitted in the current dossier. Appropriate characterisation should be provided for the colloidal silver dispersions in nano form in this submission. 3.2. FUNCTION AND USES Colloidal silver is intended to be used as an antimicrobial agent in cosmetics including toothpastes and skin care products with a maximum concentration limit of 1%. The majority of the colloidal silver dispersions in this submission (all but one) are used in skin care products. Examples of skin care products are face creams, body creams, cleansing products, shampoos and body masks. Only one of the colloidal silver dispersions is intended to be applied in oral products like toothpaste (See also Table 5 below). Table 5: Description of the function and uses of the Colloidal silver dispersions Manufacturer A, B, C, D, J, K, L E Cosmetic products the colloidal silver is used in Face care products, eye contour products, cleansing products, face mask, body care products Toothpaste Foreseeable exposure conditions Dermal route, leave-on Oral route 19PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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