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 Study* NOAEL LOAEL Effect Reference 20-day study Albino rats (Rattus rattus albino) Oral (gavage) 0 and 50 mg potassium chromate/kg b.w. per day Doses: 0, 13.4 mg Cr(VI)/kg b.w. per day (a) - 50 mg potassium chromate/k g b.w. per day 13.4 mg Cr(VI)/kg Liver: lipid accumulation particularly at perilobular zone, increase triglycerides and phospholipids, inhibition of alkaline phosphatase, acid phosphatase glucose-6-phosphatase and cholinesterase, stimulation of lipase. Kidney: lipid accumulation, increases triglycerides and phospholipids mainly in epithelium of distal tubules, inhibition of alkaline phosphatase, acid phosphatase glucose-6-phosphatase and lipase. b.w. per day 28-day study - 0, 0.07 g Slight effects on b.w. Doses: 48 mg Cr(VI)/kg b.w. per day (b) Male Wistar rats Cr(VI)/L No effects on motor activity. Oral (drinking water) (sodium 0, 0.07 g Cr(VI)/L (sodium chromate) chromate) 4.8 mg Decrease urinary excretion, proteinuria. Doses: 4.8 mg Cr(VI)/kg b.w. per day (b) Cr(VI)/kg Decrease motor activity. b.w. per 0, 0.7 g Cr(VI)/L (sodium chromate) day 0, 0.7 g Cr(VI)/L (sodium chromate) 48 mg Cr(VI)/kg b.w. per day Kumar and Rana (1982, 1984) Kumar et al. (1985) Diaz-Mayans et al. (1986) EFSA Journal 2014;12(3):3595 194
Chromium in food and bottled water Table H5: Repeated dose toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference 28-day range finding study B6C3F1 mice Oral (drinking water) 0, 15.6, 31.25, 62.5, 125 and 250 mg sodium dichromate dihydrate/L, corresponding to 0, 5.4, 10.9, 21.8, 43.6, 87.2 mg Cr(VI)/L 125 mg sodium dichromate dihydrate/L 250 mg sodium dichromate dihydrate/ L Reductions in final mean b.w. and b.w. gain at HD. In HD mice decrease erythroid parameters. Minimal effects in the various immunological parameters evaluated. NTP (2008) Doses: 0, 1, 2, 3.9, 7.8, 15.7 mg Cr(VI)/kg b.w. per day (c) Evaluation of the potential to modulate immune function 28-day range finding study F344/N and Sprague-Dawley rats Oral (drinking water) 0, 14.3, 57.3, 172 and 516 mg sodium dichromate dihydrate/L, corresponding to 0, 5, 20, 60, 180 mg Cr(VI)/L Doses: 0, 0.6, 2.4, 7.2, 21.6 mg Cr(VI)/kg b.w. per day (c) Evaluation of the potential to modulate immune function 9-week exposure Male and female BALB/c mice + 8-week recovery Oral (diet) Potassium dichromate 0, 15, 50, 100 and 400 mg/kg food, corresponding to 0, 4, 13, 28, 115 mg potassium dichromate/kg b.w. per day Doses: 0, 1.4, 4.6, 9.9, 40.7 mg Cr(VI)/kg b.w. per day (a) 7.8 mg Cr(VI)/kg b.w. per day 57.3 mg sodium dichromate dihydrate/L 2.4 mg Cr(VI)/kg b.w. per day 15 mg/kg food 1.4 mg Cr(VI)/kg b.w. per day 15.7 mg Cr(VI)/kg b.w. per day 172 mg sodium dichromate dihydrate/ L 7.2 mg Cr(VI)/kg b.w. per day 50 mg/kg food 4.6 mg Cr(VI)/kg b.w. per day Reductions in final mean b.w. and b.w. gain at HD. Decrease water consumption. Minimal effects in the various immunological parameters evaluated. Hepatocytes: cytoplasmic vacuolation. Slight reduction of b.w., MCV and MCH values at 400 mg/kg food. No effect on spermatogenesis has been reported. NTP (2008) NTP (1996a, 1997) EFSA Journal 2014;12(3):3595 195
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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 />
28-day range finding study<br />
B6C3F1 mice<br />
Oral (<strong>drinking</strong> <strong>water</strong>)<br />
0, 15.6, 31.25, 62.5, 125 and 250 mg sodium<br />
dichromate dihydrate/L, corresponding to 0,<br />
5.4, 10.9, 21.8, 43.6, 87.2 mg Cr(VI)/L<br />
125 mg<br />
sodium<br />
dichromate<br />
dihydrate/L<br />
250 mg<br />
sodium<br />
dichromate<br />
dihydrate/<br />
L<br />
Reductions in final mean b.w. and b.w. gain at HD.<br />
In HD mice decrease erythroid parameters.<br />
Minimal effects in the various immunological parameters evaluated.<br />
NTP (2008)<br />
Doses:<br />
0, 1, 2, 3.9, 7.8, 15.7 mg Cr(VI)/kg b.w.<br />
per day (c)<br />
Evaluation of the potential to modulate<br />
immune function<br />
28-day range finding study<br />
F344/N and Sprague-Dawley rats<br />
Oral (<strong>drinking</strong> <strong>water</strong>)<br />
0, 14.3, 57.3, 172 and 516 mg sodium<br />
dichromate dihydrate/L, corresponding to 0,<br />
5, 20, 60, 180 mg Cr(VI)/L<br />
Doses:<br />
0, 0.6, 2.4, 7.2, 21.6 mg Cr(VI)/kg b.w. per<br />
day (c)<br />
Evaluation of the potential to modulate<br />
immune function<br />
9-week exposure Male and female BALB/c<br />
mice + 8-week recovery<br />
Oral (diet)<br />
Potassium dichromate 0, 15, 50, 100 and<br />
400 mg/kg <strong>food</strong>, corresponding to 0, 4, 13,<br />
28, 115 mg potassium dichromate/kg b.w.<br />
per day<br />
Doses:<br />
0, 1.4, 4.6, 9.9, 40.7 mg Cr(VI)/kg b.w. per<br />
day (a)<br />
7.8 mg<br />
Cr(VI)/kg<br />
b.w. per day<br />
57.3 mg<br />
sodium<br />
dichromate<br />
dihydrate/L<br />
2.4 mg<br />
Cr(VI)/kg<br />
b.w. per day<br />
15 mg/kg<br />
<strong>food</strong><br />
1.4 mg<br />
Cr(VI)/kg<br />
b.w. per day<br />
15.7 mg<br />
Cr(VI)/kg<br />
b.w. per<br />
day<br />
172 mg<br />
sodium<br />
dichromate<br />
dihydrate/<br />
L<br />
7.2 mg<br />
Cr(VI)/kg<br />
b.w. per<br />
day<br />
50 mg/kg<br />
<strong>food</strong><br />
4.6 mg<br />
Cr(VI)/kg<br />
b.w. per<br />
day<br />
Reductions in final mean b.w. and b.w. gain at HD.<br />
Decrease <strong>water</strong> consumption.<br />
Minimal effects in the various immunological parameters evaluated.<br />
Hepatocytes: cytoplasmic vacuolation.<br />
Slight reduction of b.w., MCV and MCH values at 400 mg/kg <strong>food</strong>.<br />
No effect on spermatogenesis has been reported.<br />
NTP (2008)<br />
NTP (1996a, 1997)<br />
EFSA Journal 2014;12(3):3595 195
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