Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-104-6
CAS number: 7439-95-4
across from well water soluble magnesium salts to magnesium:
toxicity of magnesium salts can
reasonably assume to be determined by the availability of magnesium ions
in solution. The water solubility of magnesium (6.7 mg/L at 21°C/pH
10.8) is a minimium of 104
orders of magnitude lower than the water solubility of magnesium
chloride (354 g/L at 20°C), magnesium sulfate (710 g/L at 20°C) or
magensium chloride hexahydrate (1670 g/L at 20°C). Thus,
read across from magnesium salts to magnesium, based on worst case
consideration, is justified and will likely lead to rather conservative
no-effect levels. In conclusion, it was decided to waive repeated dose
toxicity testing of magnesium and to read across from magnesium salts
for animal welfare reasons.
Although no data is available on the
genotoxic potential of metallic magnesium, one may safely assume that
metallic magnesium as such cannot cross cellular membranes, but instead
only the magnesium cation. Therefore, read across with reference to
information on the mutagenicity of other magnesium substances is clearly
warranted. For soluble magnesium compounds, there is no data gap for in
vitro genotoxicity, since at least one study for the three relevant
endpoints (bacterial reverse mutation, in vitro chromosome aberration,
in vitro gene mutation) of reliability grade 2 exist.
No data on the in vivo genotoxic
potential for magnesium compounds could be identified. However, based on
the negative results in the in vitro tests, further testing of
genotoxicity is not required (cf. REACH regulation, Annex VIII, 8.4).
However, regarding the in vivo genotoxicity of soluble magnesium
compounds, the following comments are put forward:
German federal institute for risk assessment (BfR) has conducted a
comprehensive risk assessment on health effects associated with either
magnesium deficiency (hypomagnesaemia) or increased systemic magnesium
levels (hypermagnesaemia). It was concluded that the only adverse effect
following overdosage (>250mg per day in a single dose) is an
osmosis-related reversible diarrhoea
- magnesium is abundantly distributed
throughout the human body, with the highest concentration in muscle
(270mM) and bone (530mM).
Further blood concentrations are reported as 27.1-43.9mg/L.
The majority of the systemic magnesium is present intracellularly, since
over 300 enzymes are magnesium depended for the correct functioning of
the catalytic reactions
vitro genotoxicity tests are conducted with mammalians cells in standard
cell culture media such as DMEM, Ham’s F12 and RPMI1640 which are
supplemented with magnesium salts at concentrations ranging from 0.6 to
Metabolism and its Disorders, Clin
Biochem Rev, 24(2): 47–66
G.V.; et al.(Eds.) (1978) The
elemental composition of human tissues and body fluids, Verlag
None of the in vitro genotoxicity
studies rated as reliable showed any effect in bacterial reverse
mutation assays, in mammalian cell gene mutation tests (TK assay) or in
mammalian cell chromosome aberration tests, thus the classification
criteria according to Regulation (EC) 1272/2008 and subsequent
adaptations as germ cell mutagen are not met.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again