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EC number: 232-152-0 | CAS number: 7789-24-4
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Cytogentic effects on lymphocytes in osteoporotic patients on long-term fluoride therapy
- Author:
- van Asten, P., Firouz D., Adaqaplam, T.N., Ido J.T., Symen A.D.
- Year:
- 1 998
- Bibliographic source:
- Pharmacy World & Science 20(5): 214-218
Materials and methods
- Type of study / information:
- Genotoxicity (chromosome aberrations, micronuclei) in osteoporosis patients under fluoride treatment.
- Endpoint addressed:
- genetic toxicity
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- Molecular formula:
- FNa
- IUPAC Name:
- sodium fluoride
- Test material form:
- solid
Constituent 1
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- Lymphocytes of 14 non smoking female volunteers were assessed in a double blind way. 7 volunteers were treated with fluoride containing formulations in the form of sodium fluoride (NaF) and disodium monofluorophosphate (MFP) for a period of 15 months up to 49 months. All volunteers of the treatment group are osteoporosis patients. 7 female volunteers of a comparable age range served as control group and remained untreated. The serum fluoride concentrations of the test group were checked every three months. Fluoride serum concentrations were kept within a range of 0.1 to 0.2 mf F-/L.
- Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: Fluoride was applied orally in form of tablets.
TYPE OF EXPOSURE MEASUREMENT: Biomonitoring of blood every three months.
EXPOSURE LEVELS: 100 mg MFP (equivalent to 26.4 mg F- ion); 25 mg NaF (equivalent to 22.6-33.9 mg F- ion)
EXPOSURE PERIOD: MFP was applied two times daily for a period of 19 to 21 months. NaF was applied two to three times daily for 15 months up to 49 months.
Results and discussion
- Results:
- Chromosome aberrations
Chromosome aberrations were not induced in patients treated with fluoride and were comparable with the results of the untreated control group.
The mean percentage of aberrant lymphocytes was 3.4 ± 1.7 and 2.9 ± 1.6 for fluoride-treated patients and control group, respectively. Predominantly observed aberrations included chromatid gaps, chromosome and chromatid breaks. Chromosomal aberrations of sodium fluoride-treated patients did not differ from the control group; mean values for chromosome breaks were 0.4 ± 0.5 and 0.5 ± 0.7, respectively.
Micronuclei
Results did not differ significantly for patients and control volunteers.
Fluoride ions do not have any clastogenic potential in human peripheral lymphocytes as can be seen from the above results.
Applicant's summary and conclusion
- Conclusions:
- Fluoride ions do not have any clastogenic potential in human peripheral lymphocytes in vivo.
- Executive summary:
In the publication of van Asten et. al. (1998) the lymphocytes of 14 female volunteers were investigated. 7 volunteers were included in the test group and exposed to fluoride containing formulations (i.e. sodium fluoride and disodium monofluorophosphate) for a period of 15 months up to 49 months. The peripheral blood lymphocytes of these patients were stimulated to divide in vitro. Biological endpoints included the frequencies of chromosomal aberrations and micronuclei in binucleated cells. 7 female volunteers of a comparable age range served as control group and remained untreated.
Chromosome aberrations as well as micronuclei were not induced in patients treated with fluoride and were comparable with the results of the untreated control group. Thus, fluoride ions did not show any clastogenic potential in vivo in humans.
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