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 H6: Developmental and reproductive toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference Pregnant BALB/c mice Oral (drinking water) 0 or 1000 mg potassium dichromate/L Doses: 0 and 76 mg Cr(VI)/kg b.w. per day (c) 1000 mg/L Potassium dichromate 76 mg Cr(VI)/kg b.w. - No signif. change in fertility for M. No signif. diffrences in number of implantations, viable foetuses or resorptions. Additional M sacrificed on PND 50: no effect on b.w., testis weight or seminal vesicle or preputial gland weights. per day GD 12- lactation D 20 litters culled to 8 pups/litter on first day from PND 20: examination for vaginal opening PND 60: M caged with untreated F, mating for 10 days Sacrifice F 1 wk after mating period for examination of uterine contents Additional animals sacrificed on PND 50 Male BALB/c albino Swiss mice Oral (diet) 0, 100, 200 and 400 mg potassium dichromate /kg feed for 35 days Animals sacrificed at end of treatment Doses: M: 16, 28, 63 mg Cr(VI)/kg b.w. per day (c) - 100 mg potassium dichromate/kg feed 16 mg Cr5VI)/kg b.w. per day No effect on food consumption, b.w. gain, mean testes and epididymis weights. Dose-related increases in % degenerated tubules and undegenerated tubules without spermatogonia. Dose-related reduction in mean numbers spermatogonia. Dose-related increases in number of resting spermatocytes. Increases in frequency of cells in pachytene phase at all doses and in zygotene phase at 2 low dose. Reduction epididymal sperm counts and increases % abnormal sperm in the mid and high doses. (findings appeared inconsistent) Al-Hamood et al. (1998) Zahid et al. (1990) EFSA Journal 2014;12(3):3595 206
Chromium in food and bottled water Table H6: Developmental and reproductive toxicity studies with Cr(VI) compounds (continued) Study* NOAEL LOAEL Effect Reference 9-week exposure Male and female BALB/c No effect on spermatogenesis has been reported. NTP (1996a, mice + 8-week recovery 1997) Oral (diet) Potassium dichromate 0, 15, 50, 100 and 400 mg/kg food, corresponding to 0, 4, 13, 28, 115 mg potassium dichromate/kg b.w. per day Doses: 0, 1.4, 4.6, 9.9, 40.7 mg Cr(VI)/kg b.w. per day (a) -week exposure Male and female Sprague- Dawley rats+ 8-week recovery Oral (diet) Potassium dichromate 0, 15, 50, 100 and 400 mg/kg food corresponding to 0, 5.3, 17.7, 35.3, 141 mg Cr(VI)/kg food Doses: 0, 0.4, 1.1, 2.3, 9.2 mg Cr(VI)/kg b.w. per day (a) Systematic tox: 15 mg/kg food 1.4 mg Cr(VI)/kg b.w. per day Reproduction tox: 40.7 mg Cr(VI)/kg b.w. per day Systematic tox: 100 mg/kg food 2.3 mg Cr(VI)/kg b.w. per day Reproduction tox: 9.2 mg Cr(VI)/kg b.w. per day Systematic tox: 50 mg/kg food 4.6 mg Cr(VI)/kg b.w. per day Reproduction tox: - Systematic tox: 400 mg/kg food 9.2 mg Cr(VI)/kg b.w. per day Reproduction tox: - Adult male New Zealand white rabbits Oral (gavage) 0, 5 mg potassium dichromate/kg b.w. per day for 10 weeks Doses: 0, 1.8 mg Cr(VI)/kg b.w. per day (a) - 5 mg/kg b.w. potassium dichromate 1.8 mg Cr(VI)/kg b.w. per day No effect on testis, epididymus or spermatogenesis has been reported. No adverse clinical signs. Decrease b.w., mean testes and epididymis weights. Reduction mean plasma testosterone. Increases in reaction time, pH and % of dead sperm. Decreases in packed sperm volume, sperm concentratin, total sperm output, sperm motility, total motile sperm, % normal sperm, total functional sperm fraction. Seminal plasma parameters were also affected. NTP (1996b, 1997) Yousef et al. (2006) EFSA Journal 2014;12(3):3595 207
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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 />
9-week exposure Male and female BALB/c<br />
No effect on spermatogenesis has been reported.<br />
NTP (1996a,<br />
mice + 8-week recovery<br />
1997)<br />
Oral (diet)<br />
Potassium dichromate 0, 15, 50, 100 and 400<br />
mg/kg <strong>food</strong>, corresponding to 0, 4, 13, 28,<br />
115 mg potassium dichromate/kg b.w. per day<br />
Doses:<br />
0, 1.4, 4.6, 9.9, 40.7 mg Cr(VI)/kg b.w. per<br />
day (a)<br />
-week exposure Male and female Sprague-<br />
Dawley rats+ 8-week recovery<br />
Oral (diet)<br />
Potassium dichromate 0, 15, 50, 100 and 400<br />
mg/kg <strong>food</strong> corresponding to 0, 5.3, 17.7,<br />
35.3, 141 mg Cr(VI)/kg <strong>food</strong><br />
Doses:<br />
0, 0.4, 1.1, 2.3, 9.2 mg Cr(VI)/kg b.w. per<br />
day (a)<br />
Systematic tox:<br />
15 mg/kg <strong>food</strong><br />
1.4 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Reproduction<br />
tox:<br />
40.7 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Systematic tox:<br />
100 mg/kg <strong>food</strong><br />
2.3 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Reproduction<br />
tox:<br />
9.2 mg<br />
Cr(VI)/kg b.w.<br />
per day<br />
Systematic<br />
tox:<br />
50 mg/kg <strong>food</strong><br />
4.6 mg<br />
Cr(VI)/kg<br />
b.w. per day<br />
Reproduction<br />
tox: -<br />
Systematic<br />
tox:<br />
400 mg/kg<br />
<strong>food</strong><br />
9.2 mg<br />
Cr(VI)/kg<br />
b.w. per day<br />
Reproduction<br />
tox: -<br />
Adult male New Zealand white rabbits<br />
Oral (gavage)<br />
0, 5 mg potassium dichromate/kg b.w. per day<br />
for 10 weeks<br />
Doses: 0, 1.8 mg Cr(VI)/kg b.w. per day (a) - 5 mg/kg b.w.<br />
potassium<br />
dichromate<br />
1.8 mg<br />
Cr(VI)/kg<br />
b.w. per day<br />
No effect on testis, epididymus or spermatogenesis has been reported.<br />
No adverse clinical signs. Decrease b.w., mean testes and epididymis<br />
weights.<br />
Reduction mean plasma testosterone.<br />
Increases in reaction time, pH and % of dead sperm.<br />
Decreases in packed sperm volume, sperm concentratin, total sperm<br />
output, sperm motility, total motile sperm, % normal sperm, total<br />
functional sperm fraction.<br />
Seminal plasma parameters were also affected.<br />
NTP (1996b,<br />
1997)<br />
Yousef et al.<br />
(2006)<br />
EFSA Journal 2014;12(3):3595 207