Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 231-995-1 | CAS number: 7783-40-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 January 2017 - 21 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- In vitro gene mutation study in bacteria
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Magnesium fluoride
- EC Number:
- 231-995-1
- EC Name:
- Magnesium fluoride
- Cas Number:
- 7783-40-6
- Molecular formula:
- F2Mg
- IUPAC Name:
- magnesium difluoride
- Test material form:
- solid: crystalline
- Details on test material:
- - median particle size 873 um
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 662599-1
- Expiration date of the lot/batch: 31 July 2017
- Purity test date: 18 January 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at room temperature, protected from moisture
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: Test item is poorly soluble in water according to the literature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Because of the poor solubility of the test item, a preliminary experiment was conducted to determine the insolubility. Three solvent (deionised water, dimethyl sulfoxide and ethanol) were tested. The test item did not show cytotoxicity when used any of the test solvents. DMSO was selcted as a solvent for the actual test. To increase the solubility the grinding in glass mortar and 3 hour- period of solubilisation were applied. The same procedure was applied in experiments when deionised water was used as vehicle.
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: .
- Remarks:
- The Salmonella strains used in the study are histidine-dependent. The strain has rfa mutation which changes the properties of the bacterial cell wall, increasing the permeability of cells to certain types of chemicals.
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- other:
- Remarks:
- The Salmonella strains used in the study are histidine-dependent. The strain has rfa mutation which changes the properties of the bacterial cell wall, increasing the permeability of cells to certain types of chemicals.
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other:
- Remarks:
- The Salmonella strains used in the study are histidine-dependent. The strain has rfa mutation which changes the properties of the bacterial cell wall, increasing the permeability of cells to certain types of chemicals.
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other:
- Remarks:
- The Salmonella strains used in the study are histidine-dependent. The strain has rfa mutation which changes the properties of the bacterial cell wall, increasing the permeability of cells to certain types of chemicals.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other:
- Remarks:
- The E.coli WP2 uvrA strain is tryptophan-dependent. Strain has a DNA deletion that affects repair of ultraviolet light damage which greatly increases sensitivity in detecting mutagens.
- Metabolic activation:
- with and without
- Metabolic activation system:
- The mammalian liver post-mitochondrial fraction (S9)
- Test concentrations with justification for top dose:
- concentrations studied 50, 150, 500, 1500 and 5000 mg/plate.
- Vehicle / solvent:
- DMSO. In the range finding study also deionised water and ethanol were used as solvents.
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO/sterile water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO/sterile water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene - with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): app. 10^9 cells per mL
DURATION
- Preincubation period: 20 min (without metabolic activation)
- Selection time (if incubation with a selection agent): 48 - 72 h
NUMBER OF REPLICATIONS: triplaicate cultures were set up
After the incubation period, the number of revertant colonies per plate was counted by hand - Evaluation criteria:
- Considering biological relevance the test item is considered positive if the assay is valid and the following conditions are met:
- concentration-related increase over the tested range and reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation
- Mutation factor >2.
The positive result indicates that the test item induces mutations in Salmonella typhimurium or E.coli cells.
The test item for which results do not meet the above criteria is considered non-mutagenic in this test.
Negative results indicate that under the test conditions, the test item does not produce mutations in Salmonella typhimurium/E.coli cells. - Statistics:
- The mutation frequency at each dose concentration level of the test item was compared to the one observed in negative and positive controls.
The statistical analysis was carried out using unpaired T-test.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The results indicate that test item Magnesium Fluoride did not induce a statistically significant dose-related increase in the number of revertants when tested in Salmonella typhimurium TA100, TA1535, TA97, TA98 and E.coli uvrA, both with and without metabolic activation.
According to the results obtained in this test system the test item is considered non mutagenic. - Executive summary:
Magnesium Fluoridewas tested for the mutagenic potential using in vitro Bacterial Reverse Mutation Test (Ames test) (corresponding to the OECD TG No. 471). A preliminary range-finding assay was performed using three strains of Salmonella typhimurium (TA97, TA100, TA1535) up to a maximum dose of 5.0 mg/plate to determine cytotoxicity and the optimal non-toxic test dose.
Magnesium Fluoride was tested for the mutagenic potential in strains Salmonella typhimurium TA100, TA 98, TA 97, TA1535 and E.coli uvrA in the Main assay and in the assay with Pre incubation up to a maximal dose of 5.0 mg/plate in the absence external metabolic activation and in presence of external metabolic activation with S9 fractions prepared from Sprague-Dawley rat after induction Aroclor.
Magnesium Fluoride did not produce any significant increases of mutation frequency in strains up to the maximum dose of 5.0 mg/plate in strains Salmonella typhimurium TA100, TA 98, TA 97, TA1535 and E.coli uvrA both in the absence and presence of metabolic activation.
In accordance with these results Magnesium Fluoride is considered to be non mutagenic in bacterial gene mutation test system.
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.