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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ In vitro penetration data (preferably from own studies or relevant open literature) should be provided for all colloidal silver suspensions as part of the base set requirements for the assessment of cosmetic products (including proper material characterisation). 3.3.4.2. Absorption by the respiratory tract No data provided SCCS comment: Uses leading to inhalation uptake are not claimed by the Applicants and therefore not considered by the SCCS in this Opinion. 3.3.4.3. Absorption by the oral route No data provided. SCCS comment: Since the colloidal silver dispersion E is applied in toothpaste, information on oral absorption of this material should be provided including proper material characterisation. 3.3.5. Inhalation toxicity No data provided SCCS comment: Uses leading to inhalation uptake are not claimed by the Applicant and therefore not considered by the SCCS in this Opinion. 3.3.6. 3.3.6.1. No data 3.3.6.2. No data 3.3.6.3. No data Repeated dose toxicity Repeated dose oral toxicity provided. Subchronic (90 days) toxicity (oral, dermal) provided. Chronic (>12 months) toxicity provided. SCCS comment on repeated-dose toxicity: The Applicants should consider the likelihood of systemic exposure under foreseeable uses (considering oral as well as dermal uses). Information on repeated dose toxicity is necessary for the safety evaluation where the product use (e.g. as toothpaste or face care/ body care products and shampoo) could lead to internal exposure of the consumer to silver nanoparticles. In case of considerable uptake, information on carcinogenicity and reproductive toxicity would also be necessary. 23PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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