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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ 3.3.1.3. Acute inhalation toxicity No data provided. SCCS comment: As the Applicants intend to use colloidal silver only for dermal and oral applications, information on this endpoint is not required. 3.3.2. Irritation and corrosivity 3.3.2.1. Skin irritation Five references (1, 4, 7, 10, 50; corresponding to colloidal silver dispersion A, B, C, D, J, K, and L) state that the material does not exert specific irritation. Two further references (13, 15, colloidal silver dispersion E) state that there are no data available. One reference (19, colloidal silver dispersion G) mentions results from OECD TG 404, i.e. an Irritation index (PII=0,34), classified as “neglectable”. One reference (18, colloidal silver dispersion F) states there is no effect on skin irritation (rabbit, 0,5 g/ 5 ml H2O for 4h). SCCS comment: Information on skin irritation should be provided for dermally-applied cosmetic products (see SCCS 1484/12 and SCCS 1564/15). With respect to the OECD TG 404 study mentioned by ref 19, no original study report has been provided. No information on the material characterisation for the material used in the study has been given. It is not clear whether (and if so in which respect) the material used in the skin irritation study corresponds to the materials in this submission. Guideline compliance is unclear. Therefore, no conclusion can be drawn on skin irritation based on the information submitted. 3.3.2.2. Mucous membrane irritation / Eye irritation Five references (1, 4, 7, 10, 43; corresponding to colloidal silver dispersion A, B, C, D, J, K, and L) state that irritation of eye can result from extended contact. Two references (18, 19, colloidal silver dispersion F, G) state there is no irritating potential on eyes. One of them is based on OECD TG 405 (19, colloidal silver dispersion G), the other on a study using 180 mg of nanosilver in rabbits (18, colloidal silver dispersion F). One Reference (22, colloidal silver dispersion H) mentions the possibility of eye irritation and two references (13, 15, colloidal silver dispersion E) state that there are no data available. SCCS comment: Information on mucous membrane/eye irritation should be provided for orally- (toothpaste) and dermally-applied cosmetic products (see SCCS 1484/12 and SCCS 1564/15). With respect to the OECD TG 404 study mentioned by ref 19, the SCCS notes that no original study report has been provided. No information on material characterisation for the material used in the study has been given. It is not clear whether (and if so in which respect) the material used in the skin irritation study corresponds to the materials in this submission. Guideline compliance is unclear. Therefore, based on the information provided, no conclusions can be drawn with respect to mucous membrane irritation/ eye irritation. 21PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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