Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
150 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: UK Expert Group on Vitamins and Minerals assessment
Overall assessment factor (AF):
100
Explanation for the modification of the dose descriptor starting point:

The UK Expert Group on Vitamins and Minerals (EGVM) also concluded that overall there are insufficient data from human and animals studies to derive a safe upper level for chromium. However, in the opinion of the EGVM a total daily intake of about 0.15 mg trivalent chromium per kg body weight and day (or 10 mg/person) would be expected to be without adverse health effects. This value uses a 100-fold margin of safety on a study which indicates that 15 mg trivalent chromium/kg bw/day is not associated with adverse effects in the rat.

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The UK Committee on Medical Aspects of Food Policy calculated a theoretical requirement for adults from balance studies of 23 µg/day by using regression equations and concluded that a safe and adequate level of intake lies above 25 µg for adults and between 0.1 - 1 µg/kg bw/day for children and adolescents, respectively

 

Chromium deficiency has only been seen in humans in extreme cases and as part of general malnutrition. Symptoms have been shown to include impaired glucose tolerance and glucose utilisation, weight loss, neuropathy, elevated plasma fatty acids, depressed respiratory quotient and abnormalities in nitrogen metabolism.  The symptoms disappeared rapidly after oral supplementation of 200 µg/day.

Citric acid and associated salts are found in many foods and are formed in cells as a metabolite from glycolysis. There is no toxicity theshold for repeated exposure in humans, although acute toxic effects have been reported in animals. The reported toxicity thresholds for anhydrous citric acid appear in part due to effects of an irritant acid.

 

Chromium-deficiency in rats showed a similar glucose intolerance and other signs in animals include impaired growth, elevated serum cholesterol and triglycerides, increased incidence of aortic plaques, corneal lesions and decreased fertility and sperm count. 

 

The UK Expert Group on Vitamins and Minerals (EGVM) also concluded that overall there are insufficient data from human and animals studies to derive a safe upper level for chromium. However, in the opinion of the EGVM a total daily intake of about 0.15 mg trivalent chromium per kg body weight and day (or 10 mg/person) would be expected to be without adverse health effects. This value uses a 100-fold margin of safety on a study which indicates that 15 mg trivalent chromium/kg bw/day is not associated with adverse effects in the rat.

 

WHO considered that supplementation of chromium should not exceed 250 µg/day (WHO, 1996). 

 

Adult dietary chromium III intake is in the ranges of 60–170 μg/day