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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 7, 2016 - October 28, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
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: Materion / lot 662599-1
- Expiration date of the lot/batch: 31-Jul 2017
- Purity test date: 18- Jan-2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: RT, away from moisture
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: low solubility
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not expected
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 25 mg of test item were applied topically onto the tissue surface (after wetting by 25 uL sterile DPBS) by spoon, for 60 minutes.
FORM AS APPLIED IN THE TEST (if different from that of starting material) liquid or suspension
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200-SIT)
- Tissue batch number(s): Lot No. 23367
- Delivery date:October 27, 2016
- Date of initiation of testing: October 28, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: incubator 37±1°C
- Temperature of post-treatment incubation (if applicable): incubator 37±1°C, 5±1% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 15 times with DPBS
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 h
- Spectrophotometer: spectrophotometer MRX II (Dynex) Sr. No 1CXD3229
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: three - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 ul
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 ul - Duration of treatment / exposure:
- 60 ± 1 minutes
- Duration of post-treatment incubation (if applicable):
- 42 ± 2 hours
- Number of replicates:
- 3
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg of test item were applied topically onto the tissue surface (after wetting by 25 uL sterile DPBS) by spoon, for 60 minutes.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 ul Dulbecco's Phosphate-Buffered Saline (DPBS)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 ul 5% SDS - Duration of treatment / exposure:
- 60 ± 1 minutes
- Observation period:
- 42 ± 2 hours
- Number of animals:
- not used, in vitro study
- Details on study design:
-
REMOVAL OF TEST SUBSTANCE
- Washing (if done): All tissue inserts were rinsed with DPBS (15 times) to remove any residual test material, than was submerged 3 times in 150 mL of DPBS. Finally, each insert was blotted on sterile blotting paper and transferred to new 6-well plates pre-filled with 0.9 mL of fresh medium.
- Time after start of exposure: 60 min
OBSERVATION TIME POINTS
Tissue constructs were exposed to test item for 60 minutes and were then incubated at 37±1°C in a humidified atmosphere of 5±1% CO2 for 42 -hours.
SCORING SYSTEM:
- Method of calculation:
An ability of test item by to produce a decrease in cell viability was determined by using the MTT reduction assay. The celll cultures were transferred to 24-wells plate containing 0.3 mL/well of MTT reagent (1 mg/mL) and incubated at 37±1°C in a humidified atmosphere of 5±1% CO2 in air for 3 hr ± 5 min. After incubation, the cultures were rinsed with DPBS twice and transferred to new 24-well plate and extracted in 2 mL of isopropanol for 2 hours with shaking at room temperature.
2 x 200 μL of each extraction solution were transferred to a 96-well plate and the absorbances were recorded using a wavelength 540 nm.
For each individual tissue treated with test item, PC and NC, the individual relative tissue viability was calculated. For each test item, PC and NC, the mean relative viability of the three individual tissues were calculated and used for classification according to the Prediction Model. The results are shown as % of relative viability ± SD.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 94.8
- Negative controls validity:
- valid
- Remarks:
- viability % 100.0
- Positive controls validity:
- valid
- Remarks:
- viability % 6.9
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: 25 mg of the test item was added to 1 mL of the MTT medium and incubated in the incubator (37±1°C in a humidified atmosphere of 5±1% CO2 in air) for 60 min. Untreated MTT medium was used as control. The colour of treated MTT remained unchanged and it was concluded that the test item did not reduce MTT directly.
- Colour interference with MTT: The test item in a volume of 30 µL was added into 0.3 mL of purified water. The mixture was incubated in glass test tube in the incubator at 37±1°C in a humidified atmosphere of 5±1% CO2 in air for 60 min. At the end of the exposure time the presence of the staining was evaluated. The colour of mixture was unchanged and the test item has not the potential to stain tissue.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD of negative control was 1.544. Tissue viability is meeting the acceptance criterion if the mean OD of the NC tissues is ≥ 1.0 and ≤ 2.5.
- Acceptance criteria met for positive control: The viability of culture treated by positive control 5% SDS was 6.9%. The positive control met the acceptance criterion: mean tissue viability less than 20%
- Acceptance criteria met for variability between replicate measurements: The assay met the acceptance criterion as the SD calculated from individual % tissue viabilities of three identically treated replicates was < 18%.
Any other information on results incl. tables
Skin irritation potential of Magnesium Fluoride after 60 minutes exposure in reconstructed human epidermal model EpiDermTM
Test item |
OD |
SD |
Viability |
SD |
in vivo |
|
mean |
of OD |
mean (%) |
of viabilities |
prediction |
Negative controla |
1.544 |
0.081 |
100.0 |
5.24 |
NI |
Positive controlb |
0.106 |
0.020 |
6.9 |
1.27 |
I |
Magnesium Fluoride |
1.464 |
0.075 |
94.8 |
4.83 |
NI |
a DPBS
b 5% SDS
Evaluation Criteria
In vitro result |
In vivo prediction |
mean tissue viability ≤ 50% |
Irritant (I), (R38 or UN GHS category 2) |
mean tissue viability > 50% |
Non-irritant (NI), (UN GHS No Category) |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Magnesium Fluoride was examined for skin irritation in reconstructed human epidermal model EpiDermTM. Based on the results of the study, the test item is considered to be Non-irritant (NI) to the skin.
- Executive summary:
Magnesium Fluoride was examined for in vitro skin irritation in reconstructed human epidermal model EpiDermTM. The magnitude of viability was quantified by using MTT test. Validity of the test method was ascertained by positive control 5% SDS. Three tissue replicates were used for each treatment (exposure time 60 minutes), including negative and positive control.
The tissue viability met the acceptance criterion (mean OD of negative control was 1.544). The viability of culture treated by positive control 5% SDS was 6.9%. The positive control met the acceptance criterion: mean tissue viability less than 20%.
Determined viability of culture treated by Magnesium Fluoride (94.8%) fulfilled the criteria for non-irritancy. Therefore, Magnesium Fluoride is considered to be non-irritant to the skin.
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