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Diss Factsheets
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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to guideline study with acceptable restrictions. As this study is being used for read-across, the reliability has been chosen to reflect this. Read-across from magnesium chloride to magnesium carbonate is justified on the following basis. Due to the presence of acid, mainly in the form of hydrochloric acid, in the stomach, magnesium carbonate will be converted into magnesium chloride when orally ingested. Furthermore, magnesium chloride is significantly more soluble than the carbonate salt and therefore represents the worst case in terms of its bioavailability for systemic absorption. In addition, both salts have been shown to have no acute toxicity and do not exhibit evidence of systemic toxicity when tested at a concentration of 2000 mg/kg bw in acute oral studies. Magnesium carbonate and magnesium chloride also occur in the natural environment and humans are widely exposed to naturally occurring magnesium carbonate and chloride, e.g. via drinking water and food on a day to day basis. Ingested magnesium, carbonate and chloride ions are actively regulated by the body. Systemic toxicity is likely to be caused by absorption of the magnesium ion rather than either the carbonate or chloride counterions and hence studies on magnesium salts can be read across from one to the other. This study is therefore deemed reliable for read across to magnesium carbonate as it represents the worst case for potential genotoxicity.
Data source
Reference
- Reference Type:
- publication
- Title:
- Primary Mutagenicity Screening of Food Additives Currently used in Japan
- Author:
- Ishidate M, Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M & Matsuoka A
- Year:
- 1 984
- Bibliographic source:
- Fd. Chem. Toxic., 22(8): 623-636
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- The bacterial strains tested are slightly different to those recommended in the guideline. Some details regarding the method and results are not described in the report.
- Principles of method if other than guideline:
- Salmonella/ microsome tests (Ames tests) were carried out on 190 synthetic food additives and 52 food additives derived from natural sources, all of which are currently used in Japan. One of the test materials used in the study was magnesium chloride.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Magnesium chloride (see endpoint summary for justification of read-across)
- IUPAC Name:
- Magnesium chloride (see endpoint summary for justification of read-across)
- Reference substance name:
- Magnesium chloride
- EC Number:
- 232-094-6
- EC Name:
- Magnesium chloride
- Cas Number:
- 7786-30-3
- IUPAC Name:
- magnesium dichloride
- Details on test material:
- Purity: 96.3%
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94 and TA98
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver microsome fraction (S9) - prepared from the liver of Fischer rats
- Test concentrations with justification for top dose:
- Maximum dose: 100 mg/plate (represents the highest non-cytotoxic dose used in the experiment)
- Vehicle / solvent:
- - Solvent used: distilled water
Controls
- Negative solvent / vehicle controls:
- yes
- Details on test system and experimental conditions:
- Cells cultured overnight were pre-incubated with both the test sample and the S9 mix for 20 min at 37 °C before plating. Duplicate plates were used for each of six different concentrations of the sample. The number of revertant (his+) colonies was scored after incubation at 37 °C for 2 days.
- Evaluation criteria:
- The result was considered positive if the number of colonies found was twice the number in the control.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Additional information on results:
- No significant increases in the number of revertant colonies were detected in any S. typhimurium strains at the maximum dose.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Magnesium chloride was considered to be non-mutagenic under the conditions of this test.
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