Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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.