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EC number: 232-188-7 | CAS number: 7789-75-5
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- IUPAC Name:
- sodium fluoride
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot number: 199-7-4
- Expiration date of the lot/batch: not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under storage conditions: stable
- other information:
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdal, PA.
- Weight at study initiation: males 240-256g, females 218-241g
- Age: young adult
- Housing: Single, in suspended stainless steel caging with mesh floors (conform Guide for the Care and Use of Laboratory Animals (DHEW) (NIH) No. 86.23)
- Diet: Purina Rodent Chow #5012
- Water: Filtered tap water supplied ad libitum by an automatic water dispensing system.
- Identification: each cage was identified with a cage card indicating at least the study number and identification and sex of the animals. A number was allocated to each rat on receipt and a stainless steel ear tag bearing its number was attached to the rat. This number, together with the sequential animal number assigned to the study, constituted unique identification.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-71°F
- Photoperiod (hrs dark / hrs light): 12h light/dark cycle
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with water
- Details on dermal exposure:
- On the day prior to application, a group of animals was prepared by clipping (Oster model # A2 - small) the dorsal area and the trunk. After clipping and just prior to application, the animals were examined for health, weighed (initial) and the skin checked for any abnormalities.
Individual doses were calculated based on the initial bodyweights.
2000 mg/kg bw of the test substance was placed on a 2 1/4 x 3 inch adhesive backed-gauze patch, moistened with distilled watere (1 mL per 1g of test substance), then applied to a dose area of approximately 2 x 3 inch (approximately 10% of the body surface). The patch and the entire trunk of each animal were then wrapped with 3 inch Durapore tape to avoid dislocation of the patch and to minimize evaporation of the test substance. The rats were then returned to their designated cages.
After 24h of exposure to the test substance, the patches were removed and the test sites gently wiped with water and a clean towel to remove any residual test substance. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw/d
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Bodyweights:
Individual weights of the animals were recorded just prior to test substance application (initial) and again on days 7 and 14 (termination).
Cage-side observations:
The animals were observed for signs of gross toxicity, behavioral changes and mortality at 1, 3 and 24h after application and at least once daily thereafter for 14 days. Observations included gross evaluation of the skin and fur, eyes and mucous membranesk respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observations of tremors, convulsions, salivation, diarrhea, sleep and coma.
Necropsy:
All rats were euthanized via CO2 inhalation on day 14. A gross necropsy was performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- NaF
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 905 mg/kg bw
- Based on:
- element
- Remarks:
- fluoride
- Mortality:
- None
- Clinical signs:
- other: One female exhibited facial staining, diarrhea and emaciation between days 2 and 6. All other animals appeared active and healthy. Dermal irritation and/or discoloration was noted at the dose site of all animals. No other effects of gross toxicity, advers
- Gross pathology:
- All tissues and organs appeared normal.
- Other findings:
- Red lung discoloration was observed, which is consistent with euthanasia via CO2 inhalation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The single dose acute dermal LD50 was found to be > 2000 mg/kg bw.
- Executive summary:
An acute dermal toxicity test was conducted with rats to determine the potential for the test item to produce toxicity after topical application. A dose of 2000 mg/kg bw of the test item was applied to the skin of ten healthy rats for 24 hours. The animals were observed for signs of gross toxicity and mortality at least once daily for 14 days. Bodyweights were recorded just prior to application and again on days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.
All animals survived and gained bodyweight during the study. One female exhibited facial staining, diarrhea and emaciation between days 2 and 6. All other animals appeared active and healthy. Apart from the dermal irritation and/or discoloration noted at the dose site of all animals, there were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Gross necropsy findings at terminal sacrifice were generally unremarkable.
In conclusion, the single dose acute dermal LD50 was found to be > 2000 mg NaF/kg bw.
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