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 9-week exposure Male and female Sprague- NTP (1996a, 1997) Dawley rats+ 8-week recovery Oral (diet) Potassium dichromate 0, 15, 50, 100 and 400 mg/kg food corresponding to 0, 5.3, 17.7, 35.3, 141 mg Cr(VI)/kg food Doses: 0, 0.4, 1.1, 2.3, 9.2 mg Cr(VI)/kg b.w. per day (a) 100 mg/kg food 2.3 mg Cr(VI)/kg b.w. per day 400 mg/kg food 9.2 mg Cr(VI)/kg b.w. per day 3-month exposure M and F B6C3F1 mice Oral (drinking water) 0, 62.5, 125, 250, 500 or 1000 mg sodium dichromate dihydrate/L, corresponding to 0, 9, 15, 26, 45, and 80 mg sodium dichromate dihydrate /kg b.w. per day Doses: 0, 3.1, 5.2, 9.1, 15.7, 27.9 mg Cr(VI)/kg b.w. per day (a) - 62.5 mg sodium dichromate dihydrate/ L 3.1 mg Cr(VI)/kg b.w. per day Changes in MCV and MCH values in M and F at 400 mg/kg food. No effect on testis, epididymus or spermatogenesis has been reported. Dose-dependent reduction of b.w. and water consumption from 125 mg/L. Reduction of absolute liver weight in 2 upper doses, increased relative kidney weight in HD M, increase thymus weight and increase testis weight. Haematological changes: mycrocytic hypochromic anemia. Duodenum: increased incidence of epithelial hyperplasia in all exposed groups and of histiocytic cellular infiltration from 125 mg/L. Mesenteric lymph node: histiocytic hyperplasia from 125 mg/L. Stomach lesions were observed in HD M and in F of the two HD dose group. No clinical chemistry or urinalysis were performed. NTP (2007) EFSA Journal 2014;12(3):3595 196
Chromium in food and bottled water Table H5: Repeated dose toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference 3-month exposure M and F F344 rats Oral (drinking water) 0, 62.5, 125, 250, 500 or 1000 mg sodium dichromate dihydrate/L, corresponding to: M: 0, 5, 9, 17, 32, and 60 mg sodium dichromate dihydrate /kg b.w. per day F: 0, 5, 10, 18, 33, and 61 mg sodium dichromate dihydrate/kg b.w. per day Doses: M: 0, 1.7, 3.1, 5.9, 11.1, 20.9 mg Cr(VI)/kg b.w. per day (a) F: 0, 1.7, 3.5, 6.3, 11.5, 21.3 mg Cr(VI)/kg b.w. per day (a) - 62.5 mg sodium dichromate dihydrate/ L 1.7 mg Cr(VI)/kg b.w. per day Reduction of mean b.w. in M at 2 HD and in F at HD. Reduction of water consumption in M and F at 3 upper doses. Reduction of liver weight, increase spleen weight and kidney weight Haematological changes: mycrocytic hypochromic anemia. Clinical chemistry: reduced serum cholesterol and triglycerides and increased levels of alanine aminotransferase and sorbitol dehydrogenase in M & F rats. Reduced urine volume and increased specific gravity and creatinine conc. in M & F. Histiocytic cellular infiltration was observed in the duodenum in M and F, in the liver of F from 125 mg/L, in the pancreatic lymph node in M. Increased incidence of lymphoid hyperplasia and ectasia in pancreatic lymph node at HD. Stomach lesions: focal ulceration, regenerative epithelial hyperplasia NTP (2007) and squamous epithelial metaplasia at HD. Chronic liver inflammation in F at HD. Bone marrow hyperplasia in F at HD. EFSA Journal 2014;12(3):3595 197
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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 />
3-month exposure<br />
M and F F344 rats<br />
Oral (<strong>drinking</strong> <strong>water</strong>)<br />
0, 62.5, 125, 250, 500 or 1000 mg sodium<br />
dichromate dihydrate/L, corresponding to:<br />
M: 0, 5, 9, 17, 32, and 60 mg sodium<br />
dichromate dihydrate /kg b.w. per day<br />
F: 0, 5, 10, 18, 33, and 61 mg sodium<br />
dichromate dihydrate/kg b.w. per day<br />
Doses:<br />
M: 0, 1.7, 3.1, 5.9, 11.1, 20.9 mg Cr(VI)/kg<br />
b.w. per day (a)<br />
F: 0, 1.7, 3.5, 6.3, 11.5, 21.3 mg Cr(VI)/kg<br />
b.w. per day (a) - 62.5 mg<br />
sodium<br />
dichromate<br />
dihydrate/<br />
L<br />
1.7 mg<br />
Cr(VI)/kg<br />
b.w. per<br />
day<br />
Reduction of mean b.w. in M at 2 HD and in F at HD.<br />
Reduction of <strong>water</strong> consumption in M and F at 3 upper doses.<br />
Reduction of liver weight, increase spleen weight and kidney weight<br />
Haematological changes: mycrocytic hypochromic anemia.<br />
Clinical chemistry: reduced serum cholesterol and triglycerides and<br />
increased levels of alanine aminotransferase and sorbitol<br />
dehydrogenase in M & F rats.<br />
Reduced urine volume and increased specific gravity and creatinine<br />
conc. in M & F.<br />
Histiocytic cellular infiltration was observed in the duodenum in M<br />
and F, in the liver of F from 125 mg/L, in the pancreatic lymph node<br />
in M.<br />
Increased incidence of lymphoid hyperplasia and ectasia in<br />
pancreatic lymph node at HD.<br />
Stomach lesions: focal ulceration, regenerative epithelial hyperplasia<br />
NTP (2007)<br />
and squamous epithelial metaplasia at HD.<br />
Chronic liver inflammation in F at HD.<br />
Bone marrow hyperplasia in F at HD.<br />
EFSA Journal 2014;12(3):3595 197