efsa-opinion-chromium-food-drinking-water

Chromium in food and bottled water
Table H2: Developmental and reproductive toxicity studies with Cr(III) compounds (continued)
Study* NOAEL LOAEL Effect Reference
14-week oral (diet)
F344/N rats
10M + 10 F/group
0, 80, 240, 2000, 10000 or 50000 mg/kg diet
chromium picolinate monohydrate ( M: 0, 7,
20, 160, 800 or 4240 and F: 0, 6, 20, 160, 780
or 4250 mg chromium picolinate
monohydrate/kg b.w. per day)
Doses:
M: 0, 0.8, 2.4, 19.1, 95.4, 506 mg Cr(III)/kg
b.w. per day (a)
F: 0, 0.7, 2.4, 19.1, 93, 507 mg Cr(III)/kg
b.w. per day (a)
50000 mg/kg
diet
M: 506 and F:
507 mg
Cr(III)/kg
b.w. per day
- No significant changes in reproductive organ weights in M or F, in sperm
parameters in M or in estrous cyclicity in F.
Rhodes et al.
(2005)
NTP (2010)
24-weeks oral (diet) rat (Harlan Sprague
Dawley)
0, 5, 25, 50 or 100 mg Cr(III) /kg diet (as
chromium chloride or chromium picolinate)
Doses: 0, 0.45, 2.25, 4.5, 9 mg Cr(III)/kg
b.w. per day (b)
9 mg
Cr(III)/kg
b.w. per day
Male Balb-c albino Swiss mice
7-week (35 days) oral (diet)
0, 100, 200 and 400 mg/kg food chromium
sulphate
Doses:
0, 9.2, 19, 46 mg Cr(III)/kg b.w. per day (c) - 9.2 mg
Cr(III)/kg
b.w. per
day
- No toxicity observed (b.w., organ weights, blood and histological
measurements).
No changes in testis or epididymis weight.
No effect on b.w. gain, mean food consumption, testes and epididymis
weights.
Degeneration of outer cellular layer of seminiferous tubules, significant
reduction of number of spermatogonia/tubule, accumulation of germ cells
in resting spermatocytes stage, decrease number of cells at leptotene and
zygotene stages and significant increases in the number of germ cells at the
pachytene stage of meiosis.
Significant reduction of sperm count in epididymis, dose-dependent
increase in % of morphologically abnormal sperm.
b.w.: body weight; NOAEL: no-observed-adverse-effect level; LOAEL: lowest-observed-adverse-effect level; MW: molecular weight; M: male; F: female; GD: gestation day.
* 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.
Anderson et al.
(1997)
Zahid et al.
(1990)
EFSA Journal 2014;12(3):3595 191