Toxicological studies provided on the HFCs are limited. The petitioner provided data from one 28-day toxicity study investigating the toxicity of the HFC material. Adult rats were fed HFC at levels of 5, 15 or 50 mg/kg daily for 28 days, or 150 or 500 mg/kg daily for 3 weeks. The Panel derives from this study a NOAEL of 50 mg HFC/kg bw/day. The petitioner also described results from a 6-month (180-day) repeated dose oral toxicity study of supplemented potassium humate powder in beagle dogs. The Panel derives a NOAEL for supplemented potassium humate powder of 15 mg/kg bw/day, equivalent to 7 mg HFC/kg bw/day. The Panel concludes that the margin of safety, between the NOAEL from the 28-day toxicity study in rats and the estimated human exposure, amounts to only 8.8, and between the NOAEL from the 180-day beagle dog study and the estimated human exposure to 1.2. Therefore, the Panel concludes that the submitted data are insufficient to demonstrate the safety of the proposed use and use levels of iron(II)- chromium(III)- and selenium humic acid/fulvic acid chelate and supplemented (dotated) humifulvate.

Chromium(III)-, iron(II)- and selenium-humic acid/fulvic acid chelate and supplemented humifulvate added for nutritional purposes to food supplements

GRILLI, SANDRO;
2009

Abstract

Toxicological studies provided on the HFCs are limited. The petitioner provided data from one 28-day toxicity study investigating the toxicity of the HFC material. Adult rats were fed HFC at levels of 5, 15 or 50 mg/kg daily for 28 days, or 150 or 500 mg/kg daily for 3 weeks. The Panel derives from this study a NOAEL of 50 mg HFC/kg bw/day. The petitioner also described results from a 6-month (180-day) repeated dose oral toxicity study of supplemented potassium humate powder in beagle dogs. The Panel derives a NOAEL for supplemented potassium humate powder of 15 mg/kg bw/day, equivalent to 7 mg HFC/kg bw/day. The Panel concludes that the margin of safety, between the NOAEL from the 28-day toxicity study in rats and the estimated human exposure, amounts to only 8.8, and between the NOAEL from the 180-day beagle dog study and the estimated human exposure to 1.2. Therefore, the Panel concludes that the submitted data are insufficient to demonstrate the safety of the proposed use and use levels of iron(II)- chromium(III)- and selenium humic acid/fulvic acid chelate and supplemented (dotated) humifulvate.
F. Aguilar; U.R. Charrondiere; B. Dusemund; P. Galtier; J. Gilbert; D.M. Gott; S. Grilli; R. Guertler; G.E.N. Kass; J. Koenig; C. Lambré; J-C. Larsen; J-C. Leblanc; A. Mortensen; D. Parent-Massin; I. Pratt; I.M.C.M. Rietjens; I. Stankovic; P. Tobback; T. Verguieva; R.A.Woutersen.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/101818
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