Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 232-137-9 | CAS number: 7788-97-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Using World Health Organisation guidance for limits in drinking water
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
Data based on human assessments for safe exposure to fluoride of 6 mg/day above natural background limits from food and water for general population including children.
This equates to ca 12 mg/day CrF3
For workers, a modification factor of 0.5 can be used, equating to 24 mg/day CrF3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic human starting point
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Chronic human starting point
- AF for intraspecies differences:
- 1
- Justification:
- Chronic human starting point for general population
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.72 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Based on World Health Organisation limits for fluorides in drinking water
- Overall assessment factor (AF):
- 1
- Explanation for the modification of the dose descriptor starting point:
Assumes 50% ratio for oral to dermal absorption in view of inorganic nature
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)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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.
The World Health Organisation recommend 6 mg/day ingestion limits for adults for fluoride (ca 12 mg/day as CrF3) with a limit of ca 25 mg/day
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:
- high 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
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
The WHO’s drinking water quality Guideline Value for fluoride is 1.5 mg/litre (WHO, 1993)
Daily fluoride intake is recommended to be 3 mg day for adults.
Skeletal fluorosis and an increased risk of bone fractures occur as a result of long-term excessive exposure to fluoride (total intakes of 14 mg fluoride per day), and evidence suggestive of an increased risk of bone effects at total intakes above about 6 mg fluoride per day. However, low levels of fluoride are added to drinking water to aid dental health.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
