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EC number: 208-915-9 | CAS number: 546-93-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The available information indicates that magnesium carbonate is non-hazardous and no hazard classifications are proposed. Magnesium carbonate is always prepared and used as a suspension and is never isolated in its solid or powder form; therefore, exposure to aerosols, particles or droplets of magnesium carbonate of an inhalable size will not occur. As magnesium carbonate is an inorganic ionic solid, the potential for absorption through the skin is also expected to be negligible.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.23 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.23 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Additional information - General Population
Justification for derivation of a DNEL for long-term oral exposure of the general population
The Opinion of the Scientific Committee on Food of the European Commission (SCF, 2001), which reviews and summarises a number of clinical studies on oral uptake of magnesium compounds, serves as the key study for repeated-dose oral toxicity. As stated in the endpoint summary of IUCLID Section 7.10, use of data from other easily bioavailable magnesium salts for read-across to magnesium carbonate is considered appropriate, based on the assumption that the first adverse effect to occur (mild diarrhoea) is triggered by magnesium concentration rather than by an effect of the carbonate ion.
Based on the clinical studies data, SCF (2001) identified a NOAEL for oral supplementation with easily dissociable magnesium salts (i.e. on top of the normal presence of magnesium in food and beverages) of 250 mg magnesium per day. In deriving the Tolerable Upper Intake Level (UL), SCF concluded that no assessment factor (i.e. “an uncertainty factor of 1.0”) was necessary, since “data are available from many human studies involving a large number of subjects from a spectrum of lifestage groups, including adults, pregnant and lactating women, and children…[and] the NOAEL is based on a mild, transient laxative effect, without pathological sequelae, which is readily reversible and for which considerable adaptation can develop within days”. The UL for readily dissociable magnesium salts was therefore set at 250 mg Mg/day, and applies to adults, including pregnant and lactating women, and children from 4 years on. The SCF concluded it could not establish an UL for 1–3 year old children as no data were available for this age group. SCF did note, however, that “although the incidence of diarrhoea is generally higher and its effects potentially more significant in this age group than in older children or adults, there is otherwise no basis for considering that they are more susceptible to the laxation effects of Mg”.
The assessment of the SCF is supported here for use in establishing a long-term oral DNEL for the general population for magnesium carbonate. Thus:
– the starting point is the NOAEL of 250 mg Mg/day, which based on the ECHA default adult human bodyweight of 60 kg is equivalent to 4.17 mg Mg/kg bw/day;
– no interspecies assessment factor is required as the data are from human studies;
– although none of the studies covers a chronic duration, the data that are available and nature of the adverse effect is such that the present assessment supports the SCF opinion in that an assessment factor for study duration is unnecessary.
– while there may be smaller deficiencies in individual studies, taken together the available data present an evident dose-response relationship and, consequently, the present assessment supports the SCF Opinion that an assessment factor to account for data quality deficiencies is unnecessary.
However, the SCF UL does not apply to 1–3 year old children as the clinical studies did not include children within this age range. In deriving a DNEL applicable to the general population as a whole, therefore, consideration must be given to the potential additional intraspecies variability presented by this age group. In accordance with the SCF Opinion that, aside from the incidence of diarrhoea generally being higher and the effects potentially more significant in this age group, there is no basis for considering they are more susceptible to the laxation effects of magnesium, the addition of an intraspecies assessment factor of 2 is considered sufficiently protective.
Application of this intraspecies assessment factor to the NOAEL of 4.17 mg Mg/kg bw/day results in a magnesium intake of 2.08 mg Mg/kg bw/day. This corresponds (based on molecular weight conversion of magnesium to magnesium carbonate) to a DNEL for magnesium carbonate of 7.23 mg/kg bw/day.
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