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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ F Soap products, shampoo, bath/shower products, products with anti-perspirant activity G Face care products other than face mask H Body care products I Other skin care products 3.3. TOXICOLOGICAL EVALUATION Dermal route, rinse-off Dermal route Dermal route Dermal route Ref.: 55, 57, 58, 60 An overview of the toxicological studies provided is described in the Table 2A and 2B of the Annex. 3.3.1. Acute toxicity 3.3.1.1. Acute oral toxicity The oral LD50 (rats, guinea pigs) of (colloidal) silver is > 5000 mg/kg (material A, B, C, D, J, K, L) Ref.: 1, 4, 7, 10, 13, 15, 22, 43 OECD test guidelines (TG) 420, LD50 (rat) >2000 mg/kg, no symptoms of toxicity (material F, G) Oral LD50 (mice) of (colloidal) silver is > 10000 mg/kg (material H) Oral LD50 for mice is 100 mg/kg (material F) SCCS comment: Ref.: 18, 19 Ref.: 22 Ref.: 18 Although some statements have been given on the oral toxicity of colloidal silver, no original study reports have been provided. No information on material characterisation for the materials used in the studies has been given. It is not clear whether (and if so in which respect) the material used in the acute oral toxicity studies corresponds to the materials in this submission. Proper assessment of the acute toxicity relevant to the materials under consideration should be provided (see SCCS 1564/15 and SCCS 1524/13). Based on the information provided by the Applicants, no conclusion can be drawn on acute oral toxicity. 3.3.1.2. Acute dermal toxicity OECD 402, LD50 >2000 mg/kg, no symptoms of toxicity (material G) SCCS comment: Ref.: 19 No original study report has been provided. It is not clear whether the study adhered to a GLP or an OECD test guideline (TG). 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 acute dermal toxicity study corresponds to the materials of this submission. Proper assessment of the acute dermal toxicity relevant to the materials under consideration should be provided (see SCCS 1564/15 and SCCS 1524/13). Based on the information provided, no conclusion can be drawn on acute dermal toxicity. 20PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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