Registration Dossier
Registration Dossier
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EC number: 231-104-6 | CAS number: 7439-95-4
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 46.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Magnesium metal does not elicit any relevant local effects in lungs if inhaled. Because magnesium is a physiological and essential element, and because a tolerable upper intake level (UL) for magnesium was made available by the Scientific Committee on Food (SCF/CS/NUT/UPPLEV/54 Final, 11 Oct 2001), it is considered justified to use the UL of 250 mg/person and day as a starting point for derivation of a DNEL for systemic effects in workers following inhalation exposure at the work place.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- A tolerable upper intake level was made available by the Scientific Committee on Food (2001).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Any metabolism of inorganic substances can be excluded. Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1”.
- AF for other interspecies differences:
- 1
- Justification:
- Human data served as a starting point.
- AF for intraspecies differences:
- 1
- Justification:
- Data are available from many human studies involving a large number of subjects from a spectrum of life stage groups, including adults, pregnant and lactating women and children.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
For information on DNEL derivation please refer to the report “DNEL Derivation - Magnesium powder (Draft 2.0) as attached to the technical dossier.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 23.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Magnesium metal does not elicit any relevant local effects in lungs if inhaled. Because magnesium is a physiological and essential element, and because a tolerable upper intake level (UL) for magnesium was made available by the Scientific Committee on Food (SCF/CS/NUT/UPPLEV/54 Final, 11 Oct 2001), it is considered justified to use the UL of 250 mg/person and day as a starting point for derivation of a DNEL for systemic effects in general population following inhalation exposure.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- A tolerable upper intake level was made available by the Scientific Committee on Food (2001).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Any metabolism of inorganic substances can be excluded. Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1”.
- AF for other interspecies differences:
- 1
- Justification:
- Human data served as a starting point.
- AF for intraspecies differences:
- 1
- Justification:
- Data are available from many human studies involving a large number of subjects from a spectrum of life stage groups, including adults, pregnant and lactating women and children.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3.6 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- Justification:
- Human data served as a starting point.
- AF for intraspecies differences:
- 1
- Justification:
- Data are available from many human studies involving a large number of subjects from a spectrum of life stage groups, including adults, pregnant and lactating women and children.
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
For information on DNEL derivation please refer to the CSR or to the report “DNEL Derivation - Magnesium powder (Draft 2.0) as attached below.
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.
