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SCCS/1596/18 Final Opinion on Colloidal Silver (nano) __________________________________________________________________________________________ 1.Mammalian cell chromosome aberration/clastogenicity – determined either by in vitro chromosome aberration test or micronucleus test. The micronucleus test can be performed by the mononucleate or cytokinesis blocked protocols. In the cytokinesis blocked micronucleus assay, co-exposure to both cytochalasin B and the test nanomaterial for the duration of the experiment is not considered acceptable. 2. An in vitro mammalian cell gene mutation test (e.g. hprt, tk or xprt tests). Other indicator tests, such as the Comet assay, may be included as a further weight of evidence. New in vitro approaches such as cell transformation assays or toxicogenomic approaches may also be useful for identification of genotoxic as well as non-genotoxic carcinogen nanomaterials. 3. In vitro genotoxicity studies should be accompanied by an assessment of cellular and nuclear uptake to demonstrate target exposure to enable a complete evaluation of data-outputs. (b) Where point 1 and 2 indicate significant systemic uptake (c) Where point 1 and 2 indicate significant systemic uptake and/or bioaccumulation Table 2B: Summary of toxicological data provided in the submission Typ Ref Phys- Acu e chem te data E 13-15 +(3/17) X Repe Geno Geno Cancer Repro ated tox tox tox dose bact other X X X Yes X Irrita Sensiti tion sation X Yes Ab Kinetic sorp s tion XX X X A, B, C, D, J, K, L 1-12 ++ * (11/17)** Yes, oral X X Yes Yes X Yes, skin, eye Yes F16-18+(4/17)Yes,XXXX X oral eye H 22-24 +(4/17) Yes, X X X X X oral I 25-27 ++ X X X X X X (11/17) *: +, ++, +++ is available **: number of parameters available (total is 17) X: study/ data not available, not provided Yes,eye X X X X Yes X X Yes,skin,YesXX X G 19-21 + (5/17) Yes, oral, derm al X Yes X X X Yes, skin, eye X X NB: For all toxicological data in the Table: these are statements without any experimental evidence. 36PDF Image | Consumer Safety SCCS OPINION ON Colloidal Silver (nano)
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