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 H1: Repeated toxicity studies with Cr(III) compounds (continued) Study* NOAEL LOAEL Effect Reference 90-day oral (diet) Sprague-Dawley rats 0, 5, 50 or 125 mg/kg diet chromium nicotinate (0, 200, 2000 or 5000 µg Cr(III) human equivalency dose per day) Doses: M: 0, 0.04, 0.40, 1.0 mg Cr(III)/kg b.w. per day (b) F: 0, 0.04, 0.42, 1.1 mg Cr(III)/kg b.w. per day (b) 125 mg/kg diet 1 mg Cr(III)/kg b.w. per day - No adverse effect. Shara et al. (2005) 24-weeks oral (diet) rat (Harlan Sprague Dawley) 0, 5, 25, 50 or 100 mg Cr(III) /kg diet (as chromium chloride or chromium picolinate) Doses: 0, 0.45, 2.25, 4.5, 9 mg Cr(III)/kg b.w. per day (c) Anderson et al. (1997) 100 mg /kg diet 9 mg Cr(III)/kg b.w. per day 52-week oral (diet) Sprague-Dawley rats 0 or 25 mg/kg diet chromium nicotinate (0, 1000 µg Cr(III) human equivalency dose per day) Doses: M: 0, 0.17 mg Cr(III)/ kg b.w. per day (b ) F: 0, 0.22 mg Cr(III)/ kg b.w. per day (b) - 25 mg/kg diet M: 0.17/F: 0.22 mg Cr(III)/kg b.w. per day 2-year (5 days/week = 600 feeding days) oral (diet) rat (Becton 5 % (50000 Dickinson) mg/kg diet) 60 M + 60 F/group 1466 mg 0 %, 1 %, 2 % or 5 % Cr2O3 baked in bread Cr(III)/kg (0, 360, 720 and 1800 g total Cr2O3/kg b.w.) b.w. per day Animals maintained on control diets following termination of exposure until they became moribund or died. 60M + 60 F/group Doses: 0; 293; 586; 1466 mg Cr(III)/kg b.w. per day (a) - No toxicity observed (b.w., organ weights, blood and histological measurements). Animals fed chromium picolinate were found to have liver and kidney chromium concentrations two- to threefold greater than those fed chromium chloride, demonstrating the higher absorption of chromium picolinate. Signif. decrease b.w. gain at 26, 39 or 52 weeks: 7.7, 8.1 and 14.9 % in M and 5.5, 11.4 and 9.6 % in F, respectively). Shara et al. (2007) - No adverse effect. Ivankovic and Preussman (1975) EFSA Journal 2014;12(3):3595 186
Chromium in food and bottled water Table H1: Repeated toxicity studies with Cr(III) compounds (continued) Study* NOAEL LOAEL Effect Reference 2-year oral (diet) 50000 mg/kg - Increased incidence of preputial gland adenoma in NTP (2010) F: 0, 12, 61, 314 mg Cr(III)/kg b.w. per day (a) F344/N rats 50M + 50 F/group 0, 2000, 10000 or 50000 mg/kg diet chromium picolinate monohydrate ( M: 0, 90, 460 or 2400 and F: 0, 100, 510 or 2630 mg chromium picolinate monohydrate/kg b.w. per day) Doses: M: 0, 10.7, 55, 286 mg Cr(III)/kg b.w. per day (a) diet M: 286 and F: 314 mg Cr(III)/kg b.w. per day M at 10000 and 50000 ppm (> hist. C range) (1/50, 1/50, 7/50 and 4/50). The CONTAM Panel do not consider this benign lesion to be treatment-related. 2-year oral (diet) 50000 mg/kg - Decrease mean b.w. of 50000 ppm females NTP (2010) F: 0, 29, 143, 728 mg Cr(III)/kg b.w. per day (a) B6C3F1 mice 50M + 50 F/group 0, 2000, 10000 or 50000 mg/kg diet chromium picolinate monohydrate ( M: 0, 250, 1200 or 6565 and F: 0, 240, 1200 or 6100 mg chromium picolinate monohydrate/kg b.w. per day) Doses: M: 0, 30, 143, 783 mg Cr(III)/kg b.w. per day (a) diet M: 783 and F: 728 mg Cr(III)/kg b.w. per day (10 %) at 1-year, but similar to control group at 2- year. b.w.: body weight; NOAEL: no-observed-adverse-effect level; LOAEL: lowest-observed-adverse-effect level; MW: molecular weight; M: male; F: female. * In the conversions from concentration to daily doses, the MW of the anhydrous salts were used when no information on hydration number was available in the original publication. (a): Conversion using the data reported in the original publication. (b): Conversion using drinking water/feed consumption data and average body weight reported in the publication. (c): Conversion using the default correction factor for subacute/subchronic/chronic exposure via drinking water/feed from EFSA SC (2012). EFSA Journal 2014;12(3):3595 187
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Table H1: Repeated toxicity studies with Cr(III) compounds (continued)<br />
Study* NOAEL LOAEL Effect Reference<br />
2-year oral (diet)<br />
50000 mg/kg - Increased incidence of preputial gland adenoma in NTP (2010)<br />
F: 0, 12, 61, 314 mg Cr(III)/kg b.w. per day (a)<br />
F344/N rats<br />
50M + 50 F/group<br />
0, 2000, 10000 or 50000 mg/kg diet <strong>chromium</strong> picolinate<br />
monohydrate ( M: 0, 90, 460 or 2400 and F: 0, 100, 510 or<br />
2630 mg <strong>chromium</strong> picolinate monohydrate/kg b.w. per day)<br />
Doses:<br />
M: 0, 10.7, 55, 286 mg Cr(III)/kg b.w. per day (a)<br />
diet<br />
M: 286 and<br />
F: 314 mg<br />
Cr(III)/kg<br />
b.w. per day<br />
M at 10000 and 50000 ppm (> hist. C range)<br />
(1/50, 1/50, 7/50 and 4/50).<br />
The CONTAM Panel do not consider this benign<br />
lesion to be treatment-related.<br />
2-year oral (diet)<br />
50000 mg/kg - Decrease mean b.w. of 50000 ppm females NTP (2010)<br />
F: 0, 29, 143, 728 mg Cr(III)/kg b.w. per day (a)<br />
B6C3F1 mice<br />
50M + 50 F/group<br />
0, 2000, 10000 or 50000 mg/kg diet <strong>chromium</strong> picolinate<br />
monohydrate ( M: 0, 250, 1200 or 6565 and F: 0, 240, 1200 or<br />
6100 mg <strong>chromium</strong> picolinate monohydrate/kg b.w. per day)<br />
Doses:<br />
M: 0, 30, 143, 783 mg Cr(III)/kg b.w. per day (a)<br />
diet<br />
M: 783 and<br />
F: 728 mg<br />
Cr(III)/kg<br />
b.w. per day<br />
(10 %) at 1-year, but similar to control group at 2-<br />
year.<br />
b.w.: body weight; NOAEL: no-observed-adverse-effect level; LOAEL: lowest-observed-adverse-effect level; MW: molecular weight; M: male; F: female.<br />
* In the conversions from concentration to daily doses, the MW of the anhydrous salts were used when no information on hydration number was available in the original publication.<br />
(a): Conversion using the data reported in the original publication.<br />
(b): Conversion using <strong>drinking</strong> <strong>water</strong>/feed consumption data and average body weight reported in the publication.<br />
(c): Conversion using the default correction factor for subacute/subchronic/chronic exposure via <strong>drinking</strong> <strong>water</strong>/feed from EFSA SC (2012).<br />
EFSA Journal 2014;12(3):3595 187