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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 2016 - 10 November 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- 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 Advanced Chemicals Inc. lot.662599-1
- Expiration date of the lot/batch: 31 July 2017
- Purity test date: 18-Jan-2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 25°; keep away from moisture
- Stability under test conditions: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: The required amount of the test item (according to the body weight and dose) was mixed with vehicle (olive oil)
FORM AS APPLIED IN THE TEST (if different from that of starting material) liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 165 - 180 g
- Fasting period before study: over-night prior dosing
- Housing: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning.
- Diet: A laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered in recommended doses each day approximately at the same time.
- Water: The animals received tap water for human consumption. Supply of drinking was unlimited.
- Acclimation period: The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0 ± 0.3° C
- Humidity (%): 55.8 ± 2.1 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark cycle
IN-LIFE DATES: From: 21-Oct-2016 (animal delivery) To: 10-Nov-2016 (experiment termination; study day 14)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Olive oil is a standard vehicle according to OECD TG 423
- Lot/batch no. (if required): L52897
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 + 3 F. One group of 3 females was dosed first. As test item-related mortality was not observed during 24 hours another 3 females were treated at the same dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days.
- Frequency of weighing: Individual weights of animals were determined shortly before the test item was administered and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.
- Gross pathology:
- No macroscopic findings were noticed.
Any other information on results incl. tables
Sex |
Dose |
ID |
Result |
Sex |
Dose |
ID |
Result |
♀ |
2000 mg/kg |
1 |
alive |
♀ |
2000 mg/kg |
4 |
alive |
2 |
alive |
5 |
alive |
||||
3 |
alive |
6 |
alive |
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
165 |
180 |
190 |
15 |
25 |
10 |
2 |
170 |
195 |
200 |
15 |
20 |
5 |
||
3 |
170 |
190 |
195 |
10 |
15 |
5 |
||
4 |
180 |
195 |
205 |
15 |
25 |
10 |
||
5 |
170 |
200 |
205 |
30 |
35 |
5 |
||
6 |
175 |
205 |
205 |
30 |
30 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of the test item Magnesium Fluoride is higher than 2000 mg/kg body weight after single oral administration to Wistar rats. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Magnesium Fluoride is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.
- Executive summary:
The test item Magnesium Fluoride administered to 6 females at limit dose of 2000 mg/kg body weight did not cause death. Stagnation of the body weight in one animal and increase of the body weight in the rest animals were observed between one and two weeks after administration of the test item. No signs of toxicity were observed at the dosage of 2000 mg/kg body weight during the first 4 hours in females or 14-day observation period. During necropsy, no macroscopic findings were noticed.
The study is considered reliable without restrictions since the study is carried out according to OECD No. 423 guideline and in compliance with principles of Good Laboratory Paractice (GLP). Based on the study result no classification is warranted for the test susbtance according to CLP.
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