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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ 3.3.12. Human data Testing of the toxicological effects of the product was performed according to Colipa Guidelines on a group of volunteers. All participants fulfilled all the criteria for being assigned to the study, were clearly informed and gave their written consent before participation. The product was applied undiluted on the back of the volunteers repeatedly. All of the volunteers were visually controlled in periodical intervals after application. Volunteers subjectively commented product properties like unpleasant feelings, itching and burning on application area. Mild to moderate skin changes on the application area were reported, like redness, for example. Ref.: 25 Additional data Additional information states that colloidal silver dispersion A is not hazardous to human health (without any experimental data). Ref.: 37 In addition, a dermatological assessment has been conducted in a contact patch semi- occlusive test testing a dispersion called demineralised water "PPUH PAWEĊ" with silver colloid Ago at a concentration of 10 ppm. Twenty volunteers (18 women, 2 men) were selected for the study, including 20 people with a positive allergic history. No allergic reaction was observed in the entire study group (including the persons with positive allergic interview), which indicates that the preparation did not exhibit irritating and sensitising properties. Ref.: 49 SCCS comment: The SCCS has considered that the information provided by the Applicants is insufficient. The Applicants are referred to consider the published scientific literature, which is abundantly available including the occupational exposure limits (OELs; Weldon et al, 2016). Ref.: 35 3.4. EXPOSURE ASSESSMENT An overview of data on the exposure assessment provided is described in the Table 3 of the Annex. SCCS comment: No proper exposure assessment according to the SCCS Notes of Guidance has been provided by the Applicants. The Applicants are advised to consult the SCCS Notes of Guidance (http://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/ sccs_o_190.pdf) for exposure assessment and calculation of the SED. 3.5. SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Safety evaluation is not possible on the basis of the information provided by the Applicants or available from the other sources. 28PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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