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damienvanherp
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Chromium in food and bottled water Table H6: Developmental and reproductive toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference Female Swiss albino mice Oral (drinking water) 0, 250, 500 or 750 mg potassium dichromate/L, 20 days X untreated M Sacrifice on GD 19 Maternal toxicity: 500 mg/L 98 mg Cr(VI)/kg b.w. per day Junaid et al. (1996b) Doses:0, 52, 98, and 169 mg Cr(VI)/kg b.w. per day (c) Developmental toxicity: - Maternal Toxicity: 750 mg/L 169 mg Cr(VI)/kg b.w. per day Developmenta l toxicity: 250 mg/L 52 mg Cr(VI)/kg b.w. per day Litter data: Decrease number corpora lutea, no implantation sites, no resorptions, no live foetuses at HD. Dose-related decrease number implantations /litter and live foetuses/litter at 2 LD. Dose-related increase pre-implantation loss and resorptions/litter (stat signif at 500 mg/l) and post- implantation loss (at 2 LD). Decrease placental weight at 250 mg/l and increase at 500 mg/L. Fetuses: Dose-related decrease fetal weight and CRL. Signif. increase frequency of sub-dermal hemorrhagic patches, kinky tail, short tail and reduced parietal, inter-parietal and caudal ossification at 500 mg/L. Signif. increase frequency of reduced caudal ossification at 250 mg/L. Significant and dose-related increase of Cr(VI) levels in maternal blood. Dose-related increase Cr(VI) levels in placentas in 2 LD and in foetuses at 500 mg/L. b.w.: body weight; M: male; F: female; HD: highest dose; NOAEL: no-observed-adverse-effect level; LOAEL: lowest-observed-adverse-effect level; MW: molecular weight; ALT: alanine aminotransferase; AST: aspartate aminotransferase; GSH/GSSG: reduced-to-oxidized glutathione ratio; MCV: mean corpuscular volume; MCH: mean corpuscular haemoglobin; CRL: Crownrump length; PND: postnatal day; Hb: Haemoglobin; LD: low dose. * 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): Data reported in the original publication. (b): Conversion using the default correction factor for subacute/subchronic/chronic exposure via drinking water/feed from EFSA SC (2012). (c): Conversion using drinking water/feed consumption data and average body weight reported in the publication. EFSA Journal 2014;12(3):3595 218

Chromium in food and bottled water Table H7: Summary of in vivo genotoxicity of Chromium (VI) – oral route Test system/ Endpoint Female C57BL/ 6Jpun/pun mouse DNA deletions Pregnant Swiss albino mouse Micronuclei BDF1 male mouse BDF1 mouse (male and female) Swiss-Webster mouse Micronuclei Compound Dose/route Exposure time/evaluation time Potassium dichromate Potassium dichromate Sodium dichromate dihydrate Potassium dichromate Sodium dichromate dihydrate Potassium dichromate drinking water at 62.5, or 125 mg Cr(VI)/L Doses: 12.5 or 25 mg Cr(VI)//kg b.w. per day drinking water at 0, 5, or 10 mg Cr(VI)/L Doses: 0, 0.9, 1.8 mg Cr(VI)/kg b.w. per day (a) drinking water at 0, 5, or 10 mg Cr(VI)/L Doses: 0, 0.9, 1.8 mg Cr(VI)/kg b.w. per day (a) drinking water at 0, 10, or 20 mg Cr(VI)/L Doses: 0, 3, or 6 mg Cr(VI)/kg b.w. per day drinking water at 0, 5, 50, and 500 mg Cr(VI)/L Doses: F: 1.4, 14, 140 mg Cr(VI)/kg b.w. per day M: 1.65, 16.5, 165 mg Cr(VI)/kg b.w. per day drinking water at 0, 1, 5, or 20 mg Cr(VI)/L Doses: 0.2, 0.9, or 3.6 mg Cr(VI)/ kg b.w. per day (a) 10.5 to 20.5 days postcoitum 20d old offspring analysed throughout the duration of pregnancy sacrifice on d18 of pregnancy for 20 d for 210 d group 1: drinking water ad libitum, for 48 hours; group 2: two bolus doses (20 mL/kg) at 24 and 48 hrs before sacrifice Tissue Response* Reference 20-day-old offspring were harvested bone marrow cells from dams; liver and peripheral blood cells from fetuses bone marrow, peripheral blood cells mouse bone marrow cells Negative 20 mg Cr(VI)/L 6 mg Cr(VI)/kg b.w. per day Negative 500 mg Cr(VI)/L F: 140 mg Cr(VI)/kg b.w. per day M: 165 mg Cr(VI)/kg b.w. per day Negative 20 mg Cr(VI)/L 3.6 mg Cr(VI)/ kg b.w. per day Positive 62.5 mg Cr(VI)/L 12.5 mg Cr(VI)//kg b.w. per day Doseresponse; Negative 10 mg Cr(VI)/L 1.8 mg Cr(VI)/kg b.w. per day Kirpnick- Sobol et al. (2006 ) De Flora et al. (2006 ) Mirsalis et al. (1996) B6C3F1 BALB/c am3-C57BL/6 male mouse Micronuclei Sodium dichromate dihydrate drinking water at 0, 62.5, 125, or 250 mg/L (0, 21.8, 43.6, or 87.2 mg Cr(VI)/L); Doses: 0, 2.8, 5.2, or 8.7 mg Cr(VI)/kg b.w. per day for 3 mo peripheral red blood cells Equivocal 87.2 mg Cr(VI)/L (B6C3F1) Negative 87.2 mg Cr(VI)/L (BALB/c) NTP (2007) Positive 43.6 mg Cr(VI)/L (am3- C57BL/6) EFSA Journal 2014;12(3):3595 219

Chromium in <strong>food</strong> and bottled <strong>water</strong><br />

Table H6: Developmental and reproductive toxicity studies with Cr(VI) compounds (continued)<br />

Study* NOAEL LOAEL Effect Reference<br />

Female Swiss albino mice<br />

Oral (<strong>drinking</strong> <strong>water</strong>)<br />

0, 250, 500 or 750 mg potassium<br />

dichromate/L, 20 days<br />

X untreated M<br />

Sacrifice on GD 19<br />

Maternal<br />

toxicity:<br />

500 mg/L<br />

98 mg<br />

Cr(VI)/kg b.w.<br />

per day<br />

Junaid et al.<br />

(1996b)<br />

Doses:0, 52, 98, and 169 mg Cr(VI)/kg<br />

b.w. per day (c)<br />

Developmental<br />

toxicity:<br />

-<br />

Maternal<br />

Toxicity:<br />

750 mg/L<br />

169 mg<br />

Cr(VI)/kg<br />

b.w. per day<br />

Developmenta<br />

l toxicity:<br />

250 mg/L<br />

52 mg<br />

Cr(VI)/kg<br />

b.w. per day<br />

Litter data:<br />

Decrease number corpora lutea, no implantation sites, no resorptions,<br />

no live foetuses at HD.<br />

Dose-related decrease number implantations /litter and live<br />

foetuses/litter at 2 LD.<br />

Dose-related increase pre-implantation loss and resorptions/litter (stat<br />

signif at 500 mg/l) and post- implantation loss (at 2 LD).<br />

Decrease placental weight at 250 mg/l and increase at 500 mg/L.<br />

Fetuses:<br />

Dose-related decrease fetal weight and CRL.<br />

Signif. increase frequency of sub-dermal hemorrhagic patches, kinky<br />

tail, short tail and reduced parietal, inter-parietal and caudal<br />

ossification at 500 mg/L.<br />

Signif. increase frequency of reduced caudal ossification at 250<br />

mg/L.<br />

Significant and dose-related increase of Cr(VI) levels in maternal<br />

blood.<br />

Dose-related increase Cr(VI) levels in placentas in 2 LD and in<br />

foetuses at 500 mg/L.<br />

b.w.: body weight; M: male; F: female; HD: highest dose; NOAEL: no-observed-adverse-effect level; LOAEL: lowest-observed-adverse-effect level; MW: molecular weight; ALT: alanine<br />

aminotransferase; AST: aspartate aminotransferase; GSH/GSSG: reduced-to-oxidized glutathione ratio; MCV: mean corpuscular volume; MCH: mean corpuscular haemoglobin; CRL: Crownrump<br />

length; PND: postnatal day; Hb: Haemoglobin; LD: low dose.<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): Data reported in the original publication.<br />

(b): Conversion using the default correction factor for subacute/subchronic/chronic exposure via <strong>drinking</strong> <strong>water</strong>/feed from EFSA SC (2012).<br />

(c): Conversion using <strong>drinking</strong> <strong>water</strong>/feed consumption data and average body weight reported in the publication.<br />

EFSA Journal 2014;12(3):3595 218

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