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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 10th, 2016 - November 8th, 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:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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: The required amount of the test item (according to the concentration) was mixed in vehicle shortly before the administration (i.e. 100% concentration was obtained by mixing of 1g of test item with 1mL of vehicle).
The preparations were made freshly before each dosing occasion.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Suspension. The vehicle (DMSO) was selected from the recommended vehicles according to OECD 429. The test item was insoluble in the vehicle, therefore a homogeneous suspension was obtained.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: AnLab Prague, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 19.17 - 24.94g
- Housing: The animals were housed individually in polypropylene cages suspended on stainless steel racks, in a room equipped with central air-conditioning. The sanitation was performed according to standard operation procedures.
- Diet (e.g. ad libitum): A laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was served ad libitum, each day approximately at the same time. The certificate of analysis is included in the raw data.
- Water (e.g. ad libitum): The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is periodical monitored (including microbiological control) and recorded; certificate of analysis is included in raw data.
- Acclimation period: The animals were acclimated in identical conditions as during the experiment for 6 days prior to the start of treatment. The acclimation was according to standard operation procedures.
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 - 60 %.
- Photoperiod (hrs dark / hrs light): 12-hour light / 12-hour dark cycle
- IN-LIFE DATES: From: 05 October 2016 To: 08 November 2016
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Remarks:
- Vehicle – pos. control: Acetone/Olive Oil, 4:1, v/v
- Concentration:
- The Pre-screen test was performed using a dose of 100 % (v/v).
In the main test the test item at concentrations of 25%, 50% and 100% were administered. - No. of animals per dose:
- Pre-test: 2 animals
Main test: 5 animals / 100 % test item
5 animals / 50 % test item
5 animals / 25 % test item
5 animals / control (vehicle)
5 animals / positive control - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The test item was insoluble in the vehicle (DMSO) , therefore a homogeneous suspension was obtained.
- Irritation: local irritation at the application site were recorded daily
- Systemic toxicity: observed daily for any clinical signs of toxicity
- Ear thickness measurements: Ear thickness was measured by a calliper on Day 1 (pre-dose), Day 3 and Day 6.
- Erythema scores: Observation Score
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet
redness) to eschar formation preventing grading of erythema 4
MAIN STUDY
Day 1:
Each animal was identified and the body weight was recorded. To the dorsum of each ear 25µL of the appropriate dilution of the test item, or the vehicle alone was applied.
Days 2 and 3:
The application procedure carried out on day 1 was repeated.
Days 4 and 5: No treatment.
Day 6:
The body weight of each animal were recorded. 250µL of phosphate-buffered saline (PBS) containing 2 µCi (7.4 x 104 Bq) of 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine was injected into all test and control mice via the tail vein.
Five hours later, the animals were sacrificed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group (pooled treatment group approach) and weighted.
Cell suspension of lymph node cells from pooled treatment groups were prepared by gentle mechanical disaggregation by glass homogenizer. Lymph node cells were centrifuged (SOPA-00156- BIO) by 600g at 4C for 10 min. Suspension of cells were precipitated with 5% trichloroacetic acid (TCA) at 4 degC for 18-20h. Pellets were centrifuged by 2000g at 4C for 5 min., re-suspended in 1 ml TCA and transferred to gamma counting tubes for 125I-counting.
- Criteria used to consider a positive response:
Results are expressed as the Stimulation Index (SI). The SI was obtained by dividing the pooled radioactive incorporation for each treatment group by the radioactive incorporation of the pooled vehicle control group; this yields a mean SI. A substance is regarded as sensitizer in the LLNA test when SI≥3.
TREATMENT PREPARATION AND ADMINISTRATION:
The required amount of the test item (according to the concentration) was mixed in vehicle shortly before the administration (i.e. 100% concentration was obtained by mixing of 1g of test item with 1mL of vehicle).
The vehicle (DMSO) was selected from the recommended vehicles according to OECD 429. The test item was insoluble in the vehicle, therefore a homogeneous suspension was obtained.
The test item was administrated in volume of 25 uL to the dorsum of each ear. The alfa-Hexyl cinnamaldehyde (25%) as positive control and vehicle as a negative control were administrated in the same volume. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Lymph node Number of
weight (g) lymph nodes DPM SI
Positive Control 0.0838 10 7037 12.79
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.96
- Test group / Remarks:
- Magnesium Fluoride 25%
- Key result
- Parameter:
- SI
- Value:
- 1.07
- Test group / Remarks:
- Magnesium Fluoride 50%
- Key result
- Parameter:
- SI
- Value:
- 0.98
- Test group / Remarks:
- Magnesium Fluoride 100%
- Cellular proliferation data / Observations:
DETAILS ON STIMULATION INDEX CALCULATION: The pooled lymph node weights of treated groups were 0.0407g for 25% concentration, 0.0442g for 50% concentration and 0.0415g for 100% concentration of tested item. The lymph node weight of control group and positive control group were 0.0414g and 0.0838g, respectively. The DPM values for the three treated groups were 873 (25%), 976 (50%) and 889 (100%), respectively. The SI values for the three treated groups were 0.96 (25%), 1.07 (50%) and 0.98 (100%), respectively.
EC3 CALCULATION: The EC3 value could not be calculated, as all measured points were below the Stimulation Index of three.
CLINICAL OBSERVATIONS: No clinical signs of toxicity observed
BODY WEIGHTS No marked changes of mean body weight were observed during the study
Any other information on results incl. tables
Lymph node weight, DPM, SI, EC3 values.
|
Lymph node |
Number of |
|
|
|
|
weight (g) |
lymph nodes |
DPM |
SI |
EC3 |
Control |
0.0414 |
10 |
911 |
- |
-
|
Positive Control |
0.0838 |
10 |
7037 |
12.79 |
|
Magnesium Fluoride25% |
0.0407 |
10 |
873 |
0.96 |
|
Magnesium Fluoride50% |
0.0442 |
10 |
976 |
1.07 |
|
Magnesium Fluoride100% |
0.0415 |
10 |
889 |
0.98 |
Historical Control Data for Positive Control
Date |
Study No. |
DPM - negative control (vehicle) |
DPM - positive control |
Stimulation Index |
09/2016 |
600349510 |
777 |
4355 |
5.60 |
07/2016 |
600342910 |
1014 |
7601 |
7.49 |
04/2016 |
600333730 |
1093 |
6811 |
6.23 |
08/2015 |
600292090 |
313 |
3925 |
12.54* |
03/2014 |
6500000060250 |
1184.99 |
5055.63 |
4.27 |
01/2013 |
600170570 |
476.85 |
1887.81 |
3.96 |
08/2010 |
600079020 |
772.02 |
3915.76 |
5.07 |
06/2010 |
600071910 |
1067.21 |
4760.68 |
4.46 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitizing potential of Magnesium Fluoride was assessed using the murine local lymph node assay. Based on the results of this study, Magnesium Fluoride is not considered a skin sensitizer under the condition of this study.
- Executive summary:
The skin sensitization potential of Magnesium Fluoride was evaluated by LLNA method, which was developed on the basis of scientific understanding of the immunological mechanism of skin sensitization.
In our experiments, the test item was applied over three consecutive days, at three concentrations. All animals survived throughout the test period without showing any clinical signs of toxicity or local irritation. In comparison with control group, the increase in lymph node weight was observed in groups treated at 50 and 100% concentration. The increase of lymph node weight was not dose dependent. A similar trend was registered in the evaluation of DPM of the lymph nodes. Calculated SI values in treated groups remained under the value of 3, which is the threshold to consider the substance a sensitizer. Therefore, it was not possible to calculate an EC3 value.
The study is considered reliable without restrictions since it is conducted according the current guidelines and in compliance with GLP.
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.
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