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 H7: Summary of in vivo genotoxicity of Chromium (VI) - oral route (continued) Test system/ Endpoint B6C3F1 mouse Micronuclei BDF1 male mouse Micronuclei Male MS/Ae and CD-1 mouse Micronuclei Swiss albino mouse DNA damage Comet assay Swiss albino mouse DNA damage Comet assay ddY mouse DNA damage Comet assay Compound Dose/route Exposure time/evaluation time drinking water at 0, for 3 mo 62.5, 125, 250, 500, or 1000 mg/L (0, 21.8, 43.6, 87.2, 174.5, or 349 mg Cr(VI)/L); Doses: 0, 3.1, 5.2, 9.1, 15.7, or 27.9 mg Cr(VI)/kg b.w. Potassium dichromate Potassium chromate Potassium dichromate Potassium dichromate Potassium dichromate per day single gavage dose of 0 or 50 mg /kg Doses: 17.7 mg Cr(VI)/kg b.w. per day single gavage doses of 0, 10, 20, 40, 80, 160, or 320 mg/kg Doses: 0, 5.3, 10.7, 21.4, 42.8, 85.7 mg Cr(VI)/ kg b.w. per day single gavage doses of 0, 0.59,1,19, 2.38, 4.75, 9.5, 19, 38 or 76 mg/kg Doses: 0, 0.21, 0.42, 0.84, 1.68, 3.37, 6.7, 13,5 or 26.9 mg Cr(VI)/kg b.w. per day single gavage doses of 0, 25, 50 and 100 mg/kg Doses: 0, 8.8, 17.7 and 35.4 Cr(VI)/kg b.w. per day single gavage doses of 0 or 320 mg/kg Doses: 0 or 85.7 mg Cr(VI)/kg b.w. per day for 1 d or 5 consecutive d samples analysed at 3, 8 and 24 hrs after treatment Tissue Response* Reference peripheral red blood cells bone marrow cells Bone marrow cells leukocytes peripheral lymphocytes stomach, colon. Liver, kidney, bladder, lung, brain and bone marrow Negative 349 mg Cr(VI)/L 27.9 mg Cr(VI)/kg b.w. per day Negative 50 mg Cr(VI)/kg 17.7 mg Cr(VI)/ kg b.w. per day Negative Negative up to acutely toxic doses 85.7 mg Cr(VI)/ kg b.w. per day Positive 0.21 mg Cr(VI)/kg b.w. per day Positive 8.8 mg Cr(VI)/kg b.w. per day samples analysed at 24, 48, 72 and 96 hrs, and 1 and 2 wks posttreatement Doseresponse Doseresponse Positive 85.7 mg Cr(VI)/kg b.w. per day NTP (2007) De Flora et al. (2006) Shindo et al. (1989) Devi et al. (2001) Wang et al. (2006) Sekihashi et al. (2001) b.w.: body weight. * The lowest effective dose is indicated for positive results and the highest dose tested for negative results. (a): Doses calculated using the default correction factor for subacute/subchronic/chronic exposure via drinking water/feed from EFSA SC (2012). EFSA Journal 2014;12(3):3595 220
Chromium in food and bottled water Table H8: Summary of in vivo genotoxicity of Chromium (VI) - non-oral route Test system/ Endpoint Male lacZ transgenic MutaTM mouse Mutation C57BL/6 Big Blue mouse Mutation CBA . C57Bl/6J hybrid male mouse Dominant lethality (frequency of postimplantatio n loss) CBA . C57Bl/6J hybrid mouse Micronuclei Slc:ddY mouse NMRI mouse Micronuclei MS/Ae and CD- 1 male mouse Micronuclei LacZ transgenic MutaTM male mouse Micronuclei Compound Dose/route Exposure time/evaluation time Potassium chromate Potassium dichromate Potassium dichromate Potassium dichromate Potassium chromate Potassium chromate Potassium chromate Potassium chromate Single i.p. dose, with 24 hrs interval,of 0 or 40 mg/kg Doses: 0, 10.7 mg Cr(VI)/kg b.w. per day single doses (intratracheal instillation) Doses: 0 or 6.75 mg Cr(VI)/kg b.w. per day single i.p. doses of 0, 0.5, 1.0, 1.5, 2.0, 10, or 20 mg/kg Doses: 0, 0.18, 0.35, 0.53, 0.71, 3.5, or 7.1 mg Cr(VI)/kg b.w. per day repeated i.p. doses of 0, 1.0, or 2.0 mg/kg daily for 21 days Doses: 0, 0.35, 0.71 mg Cr(VI)/kg b.w. per day single i.p. doses of 0, 1, 5, or 10 mg/kg Doses: 0.35, 1.77, or 3.54 mg Cr(VI)/kg b.w. per day two i.p. doses with 24 hrs interval of 0, 30, 40, and 50 mg/kg Doses: 0, 8.0, 10.7, 13.4 mg Cr(VI)/kg b.w. per day two i.p. doses with 24 hrs interval of 0, 12.12, 24.25, or 48.5 mg/kg Doses: 0, 3.2, 6.49, or 13.0 mg Cr(VI)/kg b.w. per day single i.p. doses of 0, 10, 20, 40, or 80 mg/kg Doses: 0, 2.7, 5.3, 10.7, 21.4 mg Cr(VI)/ kg b.w. per day two i.p. doses with 24 hrs interval of 0 or 40 mg/kg Doses: 0, 10.7 mg Cr(VI)/kg b.w. per day sampling at 1 and 7 d after 2 nd treatment 4 wks for gene expression Pregnant dams were sacrificed 12–14 d after conception. samples analysed 24, 48, and 72 hrs after treatment Tissue Response* Reference liver and bone marrow cells lung, kidney, liver bone marrow cells bone marrow cells bone marrow bone marrow cells peripheral red blood cells Positive 10.7 mg Cr(VI)/kg b.w. per day Positive in lung and kidney 6.75 mg Cr(VI)/kg b.w. per day Negative in liver Positive 7.1 mg Cr(VI)/kg (acute exposure) Positive 0.71 mg Cr(VI)/kg b.w. per day (repeated exposure) Positive 0.35 mg Cr(VI)/kg b.w. per day Positive 8.0 mg Cr(VI)/kg b.w. per day Positive 13 mg Cr(VI)/kg b.w. per day Positive 10.7 mg Cr(VI)/kg b.w. per day Dose-response Positive 10.7 mg Cr(VI)/kg b.w. per day Itoh and Shimada (1998) Cheng et al. (2000) Paschin et al. (1982) Paschin and Toropzev (1982) Itoh and Shimada, (1996) Wild (1978) Shindo et al. (1989) Itoh and Shimada (1997) EFSA Journal 2014;12(3):3595 221
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Table H8: Summary of in vivo genotoxicity of Chromium (VI) - non-oral route<br />
Test system/<br />
Endpoint<br />
Male lacZ<br />
transgenic<br />
MutaTM mouse<br />
Mutation<br />
C57BL/6 Big<br />
Blue mouse<br />
Mutation<br />
CBA . C57Bl/6J<br />
hybrid male<br />
mouse<br />
Dominant<br />
lethality<br />
(frequency of<br />
postimplantatio<br />
n loss)<br />
CBA . C57Bl/6J<br />
hybrid mouse<br />
Micronuclei<br />
Slc:ddY mouse<br />
NMRI mouse<br />
Micronuclei<br />
MS/Ae and CD-<br />
1 male mouse<br />
Micronuclei<br />
LacZ transgenic<br />
MutaTM male<br />
mouse<br />
Micronuclei<br />
Compound Dose/route Exposure<br />
time/evaluation<br />
time<br />
Potassium<br />
chromate<br />
Potassium<br />
dichromate<br />
Potassium<br />
dichromate<br />
Potassium<br />
dichromate<br />
Potassium<br />
chromate<br />
Potassium<br />
chromate<br />
Potassium<br />
chromate<br />
Potassium<br />
chromate<br />
Single i.p. dose, with 24<br />
hrs interval,of 0 or 40<br />
mg/kg<br />
Doses: 0, 10.7 mg<br />
Cr(VI)/kg b.w. per day<br />
single doses (intratracheal<br />
instillation)<br />
Doses: 0 or 6.75 mg<br />
Cr(VI)/kg b.w. per day<br />
single i.p. doses of 0, 0.5,<br />
1.0, 1.5, 2.0, 10, or 20<br />
mg/kg<br />
Doses: 0, 0.18, 0.35, 0.53,<br />
0.71, 3.5, or 7.1 mg<br />
Cr(VI)/kg b.w. per day<br />
repeated i.p. doses of 0,<br />
1.0, or 2.0 mg/kg daily for<br />
21 days<br />
Doses: 0, 0.35, 0.71 mg<br />
Cr(VI)/kg b.w. per day<br />
single i.p. doses of 0, 1, 5,<br />
or 10 mg/kg Doses: 0.35,<br />
1.77, or 3.54 mg<br />
Cr(VI)/kg b.w. per day<br />
two i.p. doses with 24 hrs<br />
interval of 0, 30, 40, and<br />
50 mg/kg<br />
Doses: 0, 8.0, 10.7, 13.4<br />
mg Cr(VI)/kg b.w. per<br />
day<br />
two i.p. doses with 24 hrs<br />
interval of 0, 12.12, 24.25,<br />
or 48.5 mg/kg<br />
Doses: 0, 3.2, 6.49, or<br />
13.0 mg Cr(VI)/kg b.w.<br />
per day<br />
single i.p. doses of 0, 10,<br />
20, 40, or 80 mg/kg<br />
Doses: 0, 2.7, 5.3, 10.7,<br />
21.4 mg Cr(VI)/ kg b.w.<br />
per day<br />
two i.p. doses with 24 hrs<br />
interval of 0 or 40 mg/kg<br />
Doses: 0, 10.7 mg<br />
Cr(VI)/kg b.w. per day<br />
sampling at 1<br />
and 7 d after 2 nd<br />
treatment<br />
4 wks for gene<br />
expression<br />
Pregnant dams<br />
were sacrificed<br />
12–14 d after<br />
conception.<br />
samples<br />
analysed 24, 48,<br />
and 72 hrs after<br />
treatment<br />
Tissue Response* Reference<br />
liver and<br />
bone<br />
marrow<br />
cells<br />
lung,<br />
kidney,<br />
liver<br />
bone<br />
marrow<br />
cells<br />
bone<br />
marrow<br />
cells<br />
bone<br />
marrow<br />
bone<br />
marrow<br />
cells<br />
peripheral<br />
red blood<br />
cells<br />
Positive<br />
10.7 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Positive in lung<br />
and kidney<br />
6.75 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Negative in liver<br />
Positive<br />
7.1 mg Cr(VI)/kg<br />
(acute exposure)<br />
Positive<br />
0.71 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
(repeated<br />
exposure)<br />
Positive<br />
0.35 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Positive<br />
8.0 mg Cr(VI)/kg<br />
b.w. per day<br />
Positive<br />
13 mg Cr(VI)/kg<br />
b.w. per day<br />
Positive<br />
10.7 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Dose-response<br />
Positive<br />
10.7 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Itoh and<br />
Shimada<br />
(1998)<br />
Cheng et<br />
al. (2000)<br />
Paschin et<br />
al. (1982)<br />
Paschin<br />
and<br />
Toropzev<br />
(1982)<br />
Itoh and<br />
Shimada,<br />
(1996)<br />
Wild<br />
(1978)<br />
Shindo et<br />
al. (1989)<br />
Itoh and<br />
Shimada<br />
(1997)<br />
EFSA Journal 2014;12(3):3595 221
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