efsa-opinion-chromium-food-drinking-water

More documents

Recommendations

Info

Chromium in food and bottled water Table H5: Repeated dose toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference 2-year study F344/N rats Oral (drinking water) M & F: 0, 14.3, 57.3, 172 and 516 mg sodium dichromate dihydrate/L, corresponding to: M: 0, 0.6, 2.2, 6, 17 mg sodium dichromate dihydrate /kg b.w. per day F: 0, 0.7, 2.7, 7, 20 mg sodium dichromate dihydrate /kg b.w. per day Doses: M: 0, 0.21, 0.77, 2.1 and 5.9 mg Cr (VI)/kg b.w. per day (a) F: 0, 0.24, 0.94, 2.4 and 7.0 mg Cr (VI)/kg b.w. per day (a) F: - M: 14.3 mg sodium dichromate dihydrate/L 0.21 mg Cr (VI)/kg b.w. per day F: 14.3 mg sodium dichromate dihydrate/ L 0.24 mg Cr (VI)/kg b.w. per day M: 57.3 mg sodium dichromate dihydrate/ L Signif decrease mean b.w. gains and reduced water consumption. Erythrocyte microcytosis in M rats at 3 upper doses. Anemia in M rats. Haematology not performed in F. Increased serum ALT at 3 upper doses (< enzyme induction). Liver: increased incidence of histiocytic cellular infiltration in M at HD and in F at the 3 upper doses, increased incidence of chronic inflammation in M at 172 mg /L and in all exposed groups of F, with an increase in severity in HD F, dose-related increases in incidences of fatty change in F at the 3 upper doses. Duodenum: increased incidence of histiocytic cellular infiltration in M at 3 upper doses and at 2 HD in F. Mesenteric lymph nodes: increased incidence of histiocytic cellular infiltration in M at 3 upper doses and in F at 2 HD, increased incidence of minimal lymph node hemorrhage in M at 3 upper doses and in F at HD. NTP (2008) Pancreatic lymph node: increased incidence of histiocytic cellular infiltration in M at HD and in F at 3 upper doses. Salivary gland: atrophy in F at 2 HD. 0.77 mg Cr (VI)/kg b.w. per day 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. * 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 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 feed/drinking water from EFSA SC (2012). EFSA Journal 2014;12(3):3595 202
Chromium in food and bottled water Table H6: Developmental and reproductive toxicity studies with Cr(VI) compounds Study* NOAEL LOAEL Effect Reference Multigeneration reproductive toxicity Continuous breeding study 2-generation BALB/c mice Oral (diet) potassium dichromate 0, 100, 200 and 400 mg/kg diet F0: expo: 1 week before mating, continuous mating for 12 weeks (20 pairs) F0: Parental: 13.6 mg/ kg b.w. per day Cr(VI) Reproduction: 30.3 mg/kg b.w. per day Cr(VI) F0: Parental: 30.3 mg/ kg b.w. per day Cr(VI) Reproduction: - No treatment-related effects on fertility or reproductive performance. No effect on oestrous cyclicity of F1 animals. Parents: Slight decrease mean b.w. of HD F0 & F1 M & F. Decrease mean absolute liver weights in HD F0 M &F NTP (1997) F0: 0, 19.4, 38.6 and 85.7 mg potassium dichromate/kg b.w. per day. Doses: 0, 6.9, 13.6, 30.3 mg Cr(VI)/ kg b.w. per day (a ) Litters examined PND 1. F1 litters reared by dams until weaning on PND 21, then separated, allowed to mature for about 74 days, 20 pairs allowed to mate and produce F2 F1: Parental: 200 ppm (16.1 mg Cr(VI)/kg b.w. per day Reproduction: 400 ppm (37 mg Cr(VI)/kg b.w. per day F1: Parental: 400 ppm (37 mg Cr(VI)/kg b.w. per day Reproduction: - Treatment-related changes in haematology (decrease MCV, MCH and Hb) for F1 animals. F1:0, 22.4, 45.5, 104.9 mg potassium dichromate/kg b.w. per day. Doses: 0, 7.9, 16.1, 37 mg Cr(VI)/ kg b.w. per day (a) F2 litters reared by dams until weaning on PND 21 and then sacrificed EFSA Journal 2014;12(3):3595 203
Page 1 and 2:
EFSA Journal 2014;12(3):3595 SCIENT
Page 3 and 4:
Chromium in food and drinking water
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
Page 33 and 34:
Page 35 and 36:
Page 37 and 38:
4.2.2.1. Data collection on food (e
Page 39 and 40:
Sampling year Number of samples Chr
Page 41 and 42:
Number of analtycal results Samplin
Page 43 and 44:
4.2.4. Occurrence data by food cate
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
7.2.1.4. Genotoxicity Chromium in f
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
7.2.2.3. Developmental and reproduc
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
7.5. Dose-response assessment Chrom
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Human observations Chromium in food
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152: Chromium in food and drinking water
Page 173 and 174: Chromium in food and bottled water
Page 201: Chromium in food and bottled water
Page 235 and 236: J.1.2. mice Chromium in food and bo
Page 253 and 254:
Chromium in food and bottled water
Page 255 and 256:
Page 257 and 258:
Page 259 and 260:
Page 261:
show all

efsa-opinion-chromium-food-drinking-water

Create successful ePaper yourself

Delete template?

Save as template?