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 H3: Summary of in vivo genotoxicity of Cr(III) - oral route Test system/ Endpoint Rat (F344/N) Micronuclei Mouse (B6C3F1) Micronuclei Mouse (BDF1) Micronuclei Rats (Sprague– Dawley) Micronuclei Mouse (C57BL/6J) DNA deletions (pun reversion assay) Compound Cr picolinate Cr picolinate monohydrate Chromic potassium sulphate dodecahydrate CrK(SO 4 ) 2 x 12H 2 O Cr picolinate Cr(III) chloride salt Dose/route Oral exposure by gavage 156 to 2500 mg/kg b.w. Doses: 19.4- 310.7 mg Cr(III))/kg b.w. per day Oral exposure in feed 80 to 50.000 mg/kg diet Doses: M:2-1419 mg Cr(III)/kg b.w. per day F: 1.7-1090 mg Cr(III)/kg b.w. per day Drinking water 500mg/l Doses: M:165 mg Cr(III)/kg b.w. per day F: 140 mg Cr(III)/kg b.w. per day Single oral dose of 33, 250, 2000 mg/kg b.w. Doses: 4.1, 30.8, 246 mg Cr(III)/kg b.w. per day Drinking water to dams 1875 or 3750 mg/l Doses: 375 or 750 mg Cr(III)/kg b.w. day Exposure time/evaluation time three times at 24 hr intervals 3 months feeding for 7 months 18 and 42 hrs after administration Transplacental effect in the embryos harvested at 17.5 days postcoitum Tissue Response* Reference Bone marrow erythrocytes Peripheral blood erythrocytes Bone marrow and peripheral blood cells Bone marrow cells Developing embryos (embryo Cr(III) concentrations were 8.72 and 18.77 ng/g, respectively) Negative 2500 mg Crpic/kg b.w. 310.7 mg Cr(III))/kg b.w. per day Negative - 50.000 mg/kg 1419 mg Cr(III)/kg b.w. per day Negative 165 mg Cr(III)//kg b.w. per day Negative 246 mg Cr(III)//kg b.w. per day Positive 375 mg Cr(III)//kg b.w. per day b.w.: body weight. * The lowest effective dose is indicated for positive results and the highest dose tested for negative results. NTP (2010) NTP (2010) De Flora et al. (2006) Komorowski et al. (2008) Kirpnick- Sobol et al. (2006) EFSA Journal 2014;12(3):3595 192
Chromium in food and bottled water Table H4: Summary of in vivo genotoxicity of Cr(III) – non-oral route Test system/ Endpoint Mouse (Slc:ddY) Micronuclei Mouse (CBA/Ca) Micronuclei Comet assay Compound Cr chloride Cr picolinate Dose/route i.p. injection Doses: 0, 20.5, 41 mg Cr(III)/kg b.w. per day i.p. injection (up to 3 mg Cr-pic/kg b.w.) Doses: 0, 0.4 mg Cr(III)/kg b.w. per day Exposure time/evaluation time once a day for 2d 24 hrs after the 2 nd administration 42 hrs after injection 16 hrs after injection Tissue Response* Reference Bone marrow cells Peripheral blood cells Lymphocytes Hepatocytes Negative 62.5 mg/kg b.w. 20.5 mg Cr(III)/kg b.w. per day Negative 3 mg Crpic/kg b.w. 0.4 mg Cr(III)/kg b.w. per day Negative in both cell types 3 mg Crpic/kg b.w. b.w.: body weight; i.p.: intraperitoneal; * The lowest effective dose is indicated for positive results and the highest dose tested for negative results. Itoh and Shimada (1996) Andersson et al. (2007) EFSA Journal 2014;12(3):3595 193
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Table H4: Summary of in vivo genotoxicity of Cr(III) – non-oral route<br />
Test system/<br />
Endpoint<br />
Mouse<br />
(Slc:ddY)<br />
Micronuclei<br />
Mouse<br />
(CBA/Ca)<br />
Micronuclei<br />
Comet assay<br />
Compound<br />
Cr chloride<br />
Cr picolinate<br />
Dose/route<br />
i.p. injection<br />
Doses: 0,<br />
20.5, 41 mg<br />
Cr(III)/kg<br />
b.w. per day<br />
i.p. injection<br />
(up to 3 mg<br />
Cr-pic/kg<br />
b.w.)<br />
Doses: 0, 0.4<br />
mg<br />
Cr(III)/kg<br />
b.w. per day<br />
Exposure<br />
time/evaluation<br />
time<br />
once a day for 2d<br />
24 hrs after the 2 nd<br />
administration<br />
42 hrs after<br />
injection<br />
16 hrs after<br />
injection<br />
Tissue Response* Reference<br />
Bone<br />
marrow cells<br />
Peripheral<br />
blood cells<br />
Lymphocytes<br />
Hepatocytes<br />
Negative<br />
62.5 mg/kg<br />
b.w.<br />
20.5 mg<br />
Cr(III)/kg<br />
b.w. per day<br />
Negative<br />
3 mg Crpic/kg<br />
b.w.<br />
0.4 mg<br />
Cr(III)/kg<br />
b.w. per day<br />
Negative in<br />
both cell<br />
types<br />
3 mg Crpic/kg<br />
b.w.<br />
b.w.: body weight; i.p.: intraperitoneal;<br />
* The lowest effective dose is indicated for positive results and the highest dose tested for negative results.<br />
Itoh and<br />
Shimada (1996)<br />
Andersson et al.<br />
(2007)<br />
EFSA Journal 2014;12(3):3595 193
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