efsa-opinion-chromium-food-drinking-water

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