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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ 3.3.2.3. Airways irritation No data available. SCCS comment: As the Applicants intend to use colloidal silver only for dermal and oral applications, information on this endpoint is not required. 3.3.3. Skin sensitisation Five references (1, 4, 7, 10, 13, 15, 18) state that the colloidal silver dispersions do not exert specific sensitisation potential and do not contain any of the 36 allergens. Furthermore, there are no data on respiratory sensitisation. Ref.: 1, 4, 7, 10, 13, 15, 18 It is further stated that results of tests in volunteers with the finished product have shown no sensitisation or allergenicity. “The tests were performed with carefully selected volunteers, with the use of the dermatological patch test method according to the semi- open Declaration of Helsinki with the later subsequent additions, the EU and the Republic of Poland rules and the guidelines of the Cosmetic Europe”. Ref: 22 Additional information Additional information has been provided and states that colloidal silver dispersion A does not induce skin sensitisation (without any experimental evidence). Ref.: 42 SCCS comment: Statements made by the Applicants have not been supported by data. No study data on skin sensitisation have been provided. The Applicants did not specify the 36 allergens that are apparently not present. Adequate information on skin sensitisation on relevant materials should be present in a dossier of a cosmetic ingredient. No information on material characterisation for the material used in the study has been given. Therefore no conclusion can be drawn with respect to skin sensitisation based on the information provided. 3.3.4. Absorption 3.3.4.1. Dermal / percutaneous absorption No data provided. SCCS comment: According to the SCCS Guidance on the safety assessment of nanomaterials in cosmetics, (SCCS 1484/12) a dermal percutaneous absorption study with the relevant colloidal silver dispersions including proper material characterisation should be provided in order to determine whether there is evidence for the systemic absorption of silver nanoparticles via the skin. 22PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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