The kidney effects observed in dogs were most probably related to the large amount of test compound consumed as a bolus dose by the animals. Some recommendations for the revision of the EU specifications were proposed by the Panel. Additional information on talc (E 553b) analysed with a scanning electron microscope (SEM) indicated that the particles have an irregular shape and are non‐porous and exist as two different particle sizes of 40 and 20 μm. Diesen Zusatzstoff können Sie ohne Einschränkung verzehren. The excretion of silicon in urine was dependent on the amount of silicon in the diets, being lower in individuals on the low silicon diet and higher in individuals that received continuous antacid therapy. The Panel considered that there is no mechanistic rationale for a group ADI for silicates and silicon dioxide and the group ADI established by the SCF is obsolete. Tox Monitor Laboratories, Inc, 2000. Personal communication to EFSA following an EFSA's request. The 95th percentile of exposure was only calculated for those population groups with a sufficiently large sample size (EFSA, 2011a). Due to the limitations in the available toxicological database for individual silicates, the Panel was unable to derive ADIs for calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b). Similarly, negative control particles, attapulgite and anatase did not induce SCE's. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Reply to EFSA: re‐evaluation of food additives: call for data (14.08.2012). Therefore, it was not possible for the Panel to determine whether it was silica, silicates or silicon that was measured. A second experiment was additionally performed under the same experimental conditions with only one dose level of calcium silicate but at 5,000 mg/kg. Prenatal developmental toxicity studies with calcium silicate (Silene EF) by gavage during organogenesis in mice, rats and hamsters (FDRL, 1972) and with talc (FDRL, 1973b) in mice and rats up to 1,600 mg/kg bw per day (the highest dose tested), showed no dose‐related developmental effects. Evaluation of the carcinogenic potential and potential target organ toxicity in humans. Submitted to EFSA by CEFIC, August 2012. Normal tap water was given to the control group throughout, and on 2 days/week for the test group. Data on usage levels of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) in foods in response to the EFSA call for food additives usage level and/or concentration data in food and beverages intended for human consumption (2017). Industry (EUROTALC, 2012 (Documentation provided to EFSA n. 10)) provided information on the particle size distribution of two lots of talc (E 553b). Analysis of stones passed in urine in 1971 revealed that they predominantly consisted of opaline silica. However, the Panel noted that a solubility of 127–268 mg/L, equal to one part of substance dissolved in 4,874‐3,731 parts of water, even when the equilibrium is reached, would classify the substance as ‘very slightly soluble’ according to the classification of the solubility by JECFA (2016). Prepared for Bureau of Foods. These scenarios do not consider the intake of food supplements. Using transmission electron microscopy (TEM), after dispersion the sample in a water–isopropanol mixture and ultrasonication for 3 min, the values (by number) were as follows: 24 nm for 1 type of commercial material and 12 nm for the second one (CEFIC, 2017a (Documentation provided to EFSA n. 4)). 7.5 % and 10 female rats selected at weeks 13, 52 and 104 blood... Dies ist eine Begriffsklärungsseite zur Unterscheidung mehrerer mit demselben Wort bezeichneter Begriffe conclusion and further by. 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