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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
LOAEC
Value:
50 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
LOAEC
Value:
50 mg/m³

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
LOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
LOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

 

Magnesium

 

Workers

Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population

The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF(Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.

A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.

To cover the intra-species variation, the default AF(Assessment factor)of 5 for workers was applied to the concentration/dose descriptor (NOAEL or NOAEC).

 

The dose descriptor for dermal irritation/corrosion come from dermal acute study and dermal Repeated toxicity study. In these studies, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.

We have taken that:

• the average weight of rats is 230g (210 -251.5g), used by SIAM 32, 19/04/2011

• the dose is applied over an area which is approximately 10% of the total body surface, and

• the total body surface of rats is on the average 376 cm2 used by SIAM 32, 19/04/2011

The generic modification from the dose in mg/kg bw to NOAECmodified(in mg/cm2/day) will be

 

NOAEC in mg/cm2 =        ((average animal weight in kg) x (dose in mg/kg bw)) / Treated surface in cm2)

 

NOAEC in mg/cm2 =       (0.23 x 2000)/36.7 =12.5 mg/cm2

 -The dose was 2000 mg/kg bw in the acute study of SIAM 32, 19/04/2011

- average animal weight in kg was 0.23 kg

- Treated surface in cm2 was 36.7 cm2

 

NOAEC in mg/cm2 =       (0.23 x 2000)/36.7 =12.5 mg/cm2

Dermal exposure:

No studies were located regarding long term exposure local effects in animals after dermal exposure to various forms ofmagnesium.

For dermal exposure we taken that:

-the average weight of rats is 250g (200-300g),

-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg

corrected dermal NOAEL= oral NOAEL

1000 mg/kg bw/day 0.025 kg =

NOAELrat 25mg/kg bw/day

 

No studies were located regarding long term exposure systemic effects in animals after dermal exposure to various forms ofmagnesium.

For dermal exposure we taken that:

-the average weight of rats is 250g (200-300g),

-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg

corrected dermal NOAEL= oral NOAEL

1000mg/kg bw/day 0.025 kg =

NOAELrat 25mg/kg bw/day

 

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
LOAEC
Value:
50 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
LOAEC
Value:
50 mg/m³

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
LOAEC

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 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):
10
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 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):
10
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Magnesium

General population

Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population

The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF(Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.

A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.

To cover the intra-species variation, the default AF(Assessment factor)of 10 for general population was applied to the concentration/dose descriptor (NOAEL or NOAEC).

The dose descriptor for dermal irritation/corrosion come from dermal acute study and dermal Repeated toxicity study. In these studies, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.

We have taken that:

• the average weight of rats is 230g (210 -251.5g), used by SIAM 32, 19/04/2011

• the dose is applied over an area which is approximately 10% of the total body surface, and

• the total body surface of rats is on the average 376 cm2used by SIAM 32, 19/04/2011

The generic modification from thedose in mg/kg bw to NOAECmodified(in mg/cm2/day) will be

 

NOAEC in mg/cm2 =        ((average animal weight in kg) x (dose in mg/kg bw)) / Treated surface in cm2)

 

NOAEC in mg/cm2 =       (0.23 x 2000)/36.7 =12.5 mg/cm2

 -The dose was 2000 mg/kg bw in the acute study of SIAM 32, 19/04/2011

- average animal weight in kg was 0.23 kg

- Treated surface in cm2 was 36.7 cm2

 

NOAEC in mg/cm2 =       (0.23 x 2000)/36.7 =12.5 mg/cm2

Dermal exposure:

No studies were located regardinglong term exposure localeffects in animals after dermal exposure to various forms ofmagnesium.

Fordermalexposure we taken that:

-the average weight of rats is 250g (200-300g),

-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg

corrected dermal NOAEL= oral NOAEL

1000 mg/kg bw/day 0.025 kg =

NOAELrat25mg/kg bw/day

 

No studies were located regardinglong term exposure systemiceffects in animals after dermal exposure to various forms ofmagnesium.

For dermal exposure we taken that:

-the average weight of rats is 250g (200-300g),

-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg

corrected dermal NOAEL= oral NOAEL

1000mg/kg bw/day 0.025 kg =

NOAELrat 25mg/kg bw/day