efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water
Chromium in food and bottled water Table H5: Repeated dose toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference 22-week study - 25 mg Liver: degeneration with reticular arrangement of hepatocytes, Chopra et al. (1996) 0, 0.8 mg Cr(VI)/kg b.w. per day (c) day Female Wistar rats Oral (drinking water) 0 and 25 mg potassium dichromate/L corresponding to 0, 8.8 mg Cr(VI)/L Doses: potassium dichromate /L 0.8 mg Cr(VI)/kg b.w. per increased sinusoidal space, vacuoation and necrosis, increase serum AST and ALT, decreased level glycogen. Kidney: diffused glomerulus, degeneration of basement membrane in Bowman’s capsule, renal tubular epithelial degeneration. Decreased serum cholesterol, increased serum triglycerides and glucose levels. 22-week study Male Wistar rats Oral (drinking water) 0, 25 mg potassium dichromate/L corresponding to 0, 8.8 mg Cr(VI)/L Doses: 0, 0.8 mg Cr(VI)/kg b.w. per day (c) - 25 mg potassium dichromate /L 0.8 mg Cr(VI)/kg b.w. per Decrease serum succinate dehydrogenase. Liver: degeneration, vacuolation, increased sinusoidal space and necrosis, increase serum AST and ALT, decresed levels triglycerides and glycogen, increased levels cholesterol. Kidney: vacuolation in glomeruli, degeneration of basement membrane in Bowman’s capsule, renal tubular epithelial degeneration. Acharya et al. (2001) day 6-month study Wistar rats Oral (drinking water) 0, 25 mg potassium dichromate/L Doses: M: 1.79 mg Cr(VI)/kg b.w. per day (a) F: 2.11 mg Cr(VI)/kg b.w. per day (a) - 25 mg potassium dichromate /L 1.79 mg Cr(VI)/kg b.w. per day No effect on b.w. gain. Increased urinary excretion of albumin (marker of glomerular dysfunction) and β2-microglobulin (marker of tubular dysfunction) in F rats. No similar nephrotoxic effects observed in male rats. Vyskocil et al. (1993) EFSA Journal 2014;12(3):3595 200
Chromium in food and bottled water Table H5: Repeated dose toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference 2-year study B6C3F1 mice Oral (drinking water) M: 0, 14.3, 28.6, 85.7 and 257.4 mg sodium dichromate dihydrate/L, F: 0, 14.3, 57.3, 172 and 516 mg sodium dichromate dihydrate/L, corresponding to: M: 0, 1.1, 2.6, 7, 17 mg sodium dichromate dihydrate /kg b.w. per day F: 0, 1.1, 3.9, 9, 25 mg sodium dichromate dihydrate /kg b.w. per day 14.3 mg sodium dichromate dihydrate/ L 0.38 mg Cr (VI)/kg b.w. per day Decrease mean b.w. gain and water consumption at HD. Erythrocyte microcytosis in F mice. Anemia in F mice. Haematology not performed in M. Duodenum: dose-related increase in diffuse hyperplasia of epithelium, and increased incidence of hystiocytic cellular infiltration at 2 HD. Liver: dose-related increase of incidence of histiocytic cellular infiltration in M and F and of chronic inflammation in F at 2 HD. Mesenteric lymph node: increased incidence of histiocytic cellular infiltration. NTP (2008) Pancreatic lymph node: increased incidence of histiocytic cellular infiltration at 2 HD. Doses: M: 0, 0.38, 0.91, 2.4 and 5.9 mg Cr (VI)/kg b.w. per day (a) F: 0, 0.38, 1.4, 3.1 and 8.7 mg Cr(VI)/kg b.w. per day (a) Pancreas: increased incidence of cytoplasmic alteration in acini in M at 2 HD and in all exposed F. EFSA Journal 2014;12(3):3595 201
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Table H5: Repeated dose toxicity studies with Cr(VI) compounds (continued)<br />
Study* NOAEL LOAEL Effect Reference<br />
2-year study<br />
B6C3F1 mice<br />
Oral (<strong>drinking</strong> <strong>water</strong>)<br />
M: 0, 14.3, 28.6, 85.7 and 257.4 mg sodium<br />
dichromate dihydrate/L,<br />
F: 0, 14.3, 57.3, 172 and 516 mg sodium<br />
dichromate dihydrate/L, corresponding to:<br />
M: 0, 1.1, 2.6, 7, 17 mg sodium dichromate<br />
dihydrate /kg b.w. per day<br />
F: 0, 1.1, 3.9, 9, 25 mg sodium dichromate<br />
dihydrate /kg b.w. per day<br />
14.3 mg<br />
sodium<br />
dichromate<br />
dihydrate/<br />
L<br />
0.38 mg<br />
Cr (VI)/kg<br />
b.w. per<br />
day<br />
Decrease mean b.w. gain and <strong>water</strong> consumption at HD.<br />
Erythrocyte microcytosis in F mice.<br />
Anemia in F mice.<br />
Haematology not performed in M.<br />
Duodenum: dose-related increase in diffuse hyperplasia of<br />
epithelium, and increased incidence of hystiocytic cellular<br />
infiltration at 2 HD.<br />
Liver: dose-related increase of incidence of histiocytic cellular<br />
infiltration in M and F and of chronic inflammation in F at 2 HD.<br />
Mesenteric lymph node: increased incidence of histiocytic cellular<br />
infiltration.<br />
NTP (2008)<br />
Pancreatic lymph node: increased incidence of histiocytic cellular<br />
infiltration at 2 HD.<br />
Doses:<br />
M: 0, 0.38, 0.91, 2.4 and 5.9 mg Cr (VI)/kg<br />
b.w. per day (a)<br />
F: 0, 0.38, 1.4, 3.1 and 8.7 mg Cr(VI)/kg<br />
b.w. per day (a)<br />
Pancreas: increased incidence of cytoplasmic alteration in acini in M<br />
at 2 HD and in all exposed F.<br />
EFSA Journal 2014;12(3):3595 201
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