Registration Dossier

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.