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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
Endpoint summary
Administrative data
Description of key information
Skin irritation:
Not Irritating (in vitro skin irritation in reconstructed human epidermal model EpiDermTM). Key study; Klimisch score 1.
Eye irritation:
Not Irritating (in vitro eye irritation in human model EpiOcularTM). Key study; Klimisch score 1.
Respiratory irritation:
Irritating. No data available of the substance. Inorganic fluorides generally are considered highly irritating substances.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
- 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 - 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
- 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. - 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%. - 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.
Reference
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) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 08, 2016 - September 22, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
- 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 - Species:
- other: in vitro study
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Protocol: In vitro EpiOcularTM eye irritation test (OCL-200-EIT)
- Source: MatTek In Vitro Life Science Laboratories, SR
- Cell line: The EpiOcular™ human cell construct
- Lot: 23735
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37±1°C
- Cell Culture Conditions: a humidified atmosphere of 5±1% CO2 in air - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL AND CONTROLS
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): as such - Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used
The EpiOcularTM cultures were pre-incubated at 37±1°C in a humidified atmosphere of 5±1% CO2 for 60 min. At the end of the first pre-incubation period, the medium was replaced by 1 mL of fresh assay medium. Further, the tissues were pre-incubated in incubator overnight prior to dosing for release of transport stress related compounds and debris. After pre-incubation tissues were pre-wetted with 20 µL of Dulbecco's Phosphate Buffered Saline (DPBS), then 50 µL of control items and 50 mg of the test item were applied topically onto the tissue surface for 6 hours. Two tissues were used per treatment, negative and positive controls. After exposure period, each tissue was rinsed gently with DPBS to remove any residual test item.
- RhCE tissue construct used, including batch number
The EpiOcular™ human cell construct Lot: 23735 was delivered one day before the pre-incubation of tissues and was stored in original package at 2-8°C. At day 1, each culture was removed from the agarose gel using a sterile forceps, inspected and transferred to a pre-labeled 6-well plates containing 1 mL of assay medium per well.
- Doses of test chemical and control substances used
50 mg and 50 µl, respectively
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
After post-soak immersion at room temperature, tissues than were transferred to fresh medium and incubated for 18 hours.
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
Before testing, test item was checked for its ability to reduce MTT directly. For this purpose, a 1.0 mg/mL MTT solution (in DMEM) was prepared. 50 mg of the test item was added to 1 mL of the MTT solution in a 6-well plate and the mixture was incubated in the dark at 37 +/- 1°C in a humidified atmosphere of 5 +/- 1% CO2 in air (standard culture conditions) for three hours. A negative control (50 μL of aqua pro injectione) was run concurrently. At the end of the exposure time the colour of treated MTT remained unchanged and it was concluded that the test item did not reduce MTT directly.
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable)
Two
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
Spectrophotometer MRX II (Dynex), wavelength 540nm
- Description of the method used to quantify MTT formazan
The MTT assay was performed by transferring the tissues to 24-wells plate containing MTT medium (1 mg/mL) and incubated at 37±1°C in a humidified atmosphere of 5±1% CO2 in air for 3 hours. After incubation, the blue formazan salt formed by cellular mitochondria was extracted with 2 mL/tissue of isopropanol for 2 hours with shaking at room temperature. Each extraction solutions in a volume of 200 μL were transferred to a 96-well plate and the optical density of extracted formazan was determined using a spectrophotometer at 540 nm.
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
60%, established cut-off value (Draft revised TG492, July 2016)
- Positive and negative control means and acceptance ranges based on historical data
Negative Control (NC):
The negative control OD > 1.0 and < 2.6.
Positive Control (PC):
The mean relative viability of the positive control is at 6 hours exposure below 60% of control viability.
- Acceptable variability between tissue replicates for positive and negative controls and for the test chemical
The difference of viability between the two relating tissues of a single chemical is < 20% in the same run - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- The mean tissue viability (%)
- Value:
- 109.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100.0
- Positive controls validity:
- valid
- Remarks:
- 17.3
- Other effects / acceptance of results:
- OTHER EFFECTS:
not observed
DEMONSTRATION OF TECHNICAL PROFICIENCY:
not demonstrated
ACCEPTANCE OF RESULTS:
Concurrent positive and negative controls were used to ensure adequate performance of the experimental model. Validity of the test method was ascertained by positive control methyl acetate and negative control aqua pro injectione. The tissue viability met the acceptance criterion; mean OD of negative control was 1.172.
The viability of culture treated by positive control methyl acetate was 17,3 %. The positive control met the acceptance criterion: mean tissue viability less than 60%.
- Range of historical values if different from the ones specified in the test guideline: - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Magnesium Fluoride was examined for eye irritation potential in EpiOcularTM Eye Irritation Test (OCL-200-EIT). Based on the results of the study, the test item is considered to be Non-irritant (NI).
- Executive summary:
The test item Magnesium Fluoride was examined for in vitro eye irritation in human model EpiOcularTM. The magnitude of viability was quantified by using MTT test.
Validity of the test method was ascertained by positive control methyl acetate. Two tissue replicates were used for each treatment (exposure time 6 hours), including negative and positive controls. The tissue viability met the acceptance criterion (mean OD of negative control was 1.172). The viability of culture treated by positive control methyl acetate was 17.3%. The positive control met the acceptance criterion: mean tissue viability less than 60%.
Determined viability of culture treated by Magnesium Fluoride (109.1%) fulfilled the criteria for irritancy.
Therefore, the test item Magnesium Fluoride is considered to be non-irritant to the eye.
Reference
Test item |
OD |
SD |
Viability |
SD |
in vivo |
|
mean |
of OD |
mean (%) |
of viabilities |
prediction |
Negative controla |
1.172 |
0.033 |
100.0 |
2.77 |
NI |
Positive controlb |
0.203 |
0.020 |
17.3 |
1.66 |
I |
Magnesium Fluoride |
1.279 |
0.010 |
109.1 |
0.81 |
NI |
a H2O
b methyl acetate
Evaluation Criteria
In vitro result In vivo prediction
mean tissue viability ≤ 60% Irritant (I)
mean tissue viability > 60% Non-irritant (NI)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
A good quality guideline compliant skin irritation study (OECD 439 -in vitro skin irritation in reconstructed human epidermal model EpiDermTM) was conducted for magnesium fluoride (Bednáriková, M. 2016a).The purpose of the study was to evaluate the skin irritation potential of the test item Magnesium Fluoride by EpiDermTM in vitro model by measuring test item induced decrease in cell viability (as determined by using the MTT reduction assay) below defined threshold levels. The method involved a 60- minute exposure of tissues to the test item.
In the study three tissue replicates were used for each treatment, including negative and positive control. After exposure each tissue was washed and post-incubated for 42 -hours post-incubated. The cultures were transferred to 24-wells plate containing MTT reagent (1 mg/mL) and incubated in a humidified atmosphere 3 h. After incubation, the cultures were rinsed twice and transferred to new 24-well plate and extracted in isopropanol with shaking at room temperature.
Each extraction solution was transferred to a 96-well plate and the absorbances were recorded.
Validity of the test method was ascertained by positive control (5% SDS) and by negative control (sterile DPBS). The tissue viability of negative control and viability of culture treated by positive control determined in this study were compared with the historical data values. The tissue viability met the acceptance criterion (mean OD of negative control was 1.544). The positive control met the acceptance criterion: mean tissue viability was 6.9% (less than 20%). The viability of culture treated by Magnesium Fluoride was 94.8%. Therefore, magnesium fluoride is considered to be non-irritant to the skin.
Eye irritation
A good quality guideline compliant eye irritation study (OECD 492 –in vitro eye irritation in Reconstructed Human Cornea-like Epithelium (RhCE)) was conducted for magnesium fluoride (Bednáriková, M. 2016b). Aim of the study was to examine the acute eye irritation potential of the test item by measurement of its cytotoxic effect on the EpiOcular™ cornea epithelial model. The EpiOcular tissue construct is a nonkeratinized epithelium prepared from normal human keratinocytes (MatTek).
In this assay, the test article was applied to the surface of the cornea epithelial construct for 6 hours. After exposure period, each tissue was extensively rinsed, and the tissue was allowed to express the resulting damage.
Two construct tissues are used for the treatment with test item and for negative and positive controls. The MTT assay was performed to determine tissue viability. The tissues were transferred in the 24-wells plate containing MTT medium (1 mg/mL) and incubated in a humidified atmosphere for 3 hours. After incubation the blue formazan salt formed was extracted in isopropanol and the optical density of extracted formazan was determined using a spectrophotometer at 540 nm.
Validity of the test method was ascertained by positive control (methyl acetate) and negative control (aqua pro injection). The tissue viability met the acceptance criterion as the mean OD of negative control was 1.172 (acceptance criteria OD > 1.0 and < 2.6). The positive control met the acceptance criterion as the viability of culture treated by methyl acetate was 17.3% (less than 60%).The viability of culture treated by magnesium fluoride was 109.1%. Therefore, the test item magnesium fluoride is considered to be non-irritant to the eye.
Respiratory irritation
Potential respiratory irritation properties of magnesium fluoride have not been thoroughly investigated and recorded. However, it is generally known that the exposure of humans to airborne contaminants and particulates, may cause adverse effects on the respiratory system. The particle size distribution of the magnesium fluoride (Smeykal, H. 2016) showed median particle size D50 = 873 um and only approximately 0.3 Vol.-% is of inhalable size i.e. smaller than 100 um.
However, inorganic fluorides are considered highly irritating substances. Epidemiological investigations of workers in aluminium smelters (i.e. occupationally exposed to airborne fluorides) have reported e.g., reduced lung capacity, irritation of the respiratory tract, asthma, cough and/or bronchitis)(WHO, 2002). However, the effects observed on these studies may not be possible to attribute solely to fluoride per se owing to the exposure of these workers to other airborne contaminants and particulates.
Justification for classification or non-classification
The result of the key study (Bednáriková, M. 2016a) does not indicate Magnesium Fluoride to be classified for skin irritant according to CLP Regulation 1272/2008.
The result of the key study (Bednáriková, M. 2016b) does not indicate Magnesium Fluoride to be classified for eye irritant according to CLP Regulation 1272/2008.
Evidence on respiratory tract irritation of inorganic fluorides (WHO, 2002) suggests that the substance has to be classified to hazard class STOT SE 3 H335 according to CLP Regulation 1272/2008.
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