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EC number: 232-151-5 | CAS number: 7789-23-3
- 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
Based on the reported acute oral LD50 values for sodium fluoride in experimental animals, fluoride salts are considered moderately toxic if ingested.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according generally valid procedures and all parameters described were closely related or comparable to guideline methods.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- - a control group was not included.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Portage, MI, USA
- Weight at study initiation: 190 - 300 g (fasted weight)
- Fasting period before study: No data
ENVIRONMENTAL CONDITIONS
- Followed approved Standard Operating Procedures of the test facility
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4.0% w/v in deionized water
- Amount of test substance and vehicle dosed (if gavage): 2.86, 3.4, 4.0 or 5.6 mL/kg body weight
- Justification for choice of vehicle: test substance was readily soluble up to 4% in water
- Doses:
- Dose levels evaluated were: 114, 136, 160 and 224 mg NaF/kg body weight.
- No. of animals per sex per dose:
- 10 female rats per dose
- Control animals:
- no
- Details on study design:
- After a single oral gavage dose, all animals were observed for mortality at frequent intervals during the first 4 hours after dosing (at least once during the first 30 minutes) and daily thereafter for the next 14 days.
- Statistics:
- The LD50 value and 95% confidence limits were calculated by the Probit Method [ J. Finney, Probit Analysis, 3rd Ed., Cambridge Univ. Press, 1971, pp. 50-90] by use of the computer program BLISS17 [Fortran version of BLISS17 program, written by D.J. Finney].
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 148.5 mg/kg bw
- 95% CL:
- 116.3 - 185.5
- Mortality:
- Dose Level Number of Deaths
114 mg/kg 2/10
136 mg/kg 4/10
160 mg/kg 7/10
224 mg/kg 8/10
336 mg/kg 8/8
500 mg/kg 8/8 - Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for sodium fluoride in female Sprague-Dawley rats was 148.5 mg/kg body weight with 95% confidence limits of 116.3 - 185.5 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 248 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- May 1995 - June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study comply with the Principles of GLP OECD and was conducted in accordance with EPA OPP 81-4 guideline.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Remarks:
- GLP statement included
- Limit test:
- no
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- inhalation
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0.52, 1.02 and 1.98 mg/L
- No. of animals per sex per dose:
- five males and five females per group
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed at least daily for signs of gross toxicity and mortality; bodyweights recorded just prior to exposure (day 0) and on days 7 and 14 (i.e. termination) or after death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Mortality at 0.52 mg/L: Total 2/10 (i.e. Males 0/5; Females 2/5)
Mortality at 1.02 mg/L: Total 5/10 (i.e. Males 1/5; Females 4/5)
Mortality at 1.98 mg/L: Total 8/10 (i.e. Males 3/5; Females 5/5) - Clinical signs:
- other: All animals, irrespective of their exposure level, displayed clinical signs such as: ocular and nasal discharge facial staining ano-genital staining abnormal respiration abnormal posture pilo-erection hypoactivity. Survivors from all exposure groups reco
- Body weight:
- Some surviving animals lost bodyweight through day 7, however all gained weight over the entire 14 -day observation period.
- Gross pathology:
- - Gross necropsy of decedents:
discoloration of the lungs, gastro-intestinal tract, liver and spleen; edema of the lungs; distention of the gastro-intestinal tract; fluid in the stomach and/or rigor mortis.
- Gross necropsy of survivors from all groups was generally unremarkable. Two survivors from the group exposed to 0.52 mg/L exhibited dark red foci on the lungs. - Conclusions:
- An acute inhalation toxicity study was conducted with rats to determine the toxicity via inhalation for NaF and the defined LC50 value is 1.00 mg/L.
- Executive summary:
An acute inhalation toxicity study was conducted with rats to determine the toxicity via inhalation for NaF.
After establishing the desired generation procedures during pre-test trials, 30 healthy rats were selected and equally distributed into three exposure groups of five males and five females each. Exposure values were 0.52, 1.02 and 1.98 mg/L and each test group was exposed for four hours. Chamber concentration and particle size distribution were determined periodically during each exposure.
The animals were observed for signs of gross toxicity and mortality at least daily for 14 days. Bodyweights were recorded just prior to exposure (day 0) and again on days 7 and 14 (i.e. termination) or after death. Necropsies were performed on all animals.
The mortality at each exposure level is provided below:
Exposure levelmg/L Mortality Males Females Total 0.52 0/5 2/5 2/10 1.02 1/5 4/5 5/10 1.98 3/5 5/5 8/10 Following exposure all animals, irrespective of their exposure level, displayed clinical signs such as: ocular and nasal discharge, facial staining, ano-genital staining, abnormal respiration, abnormal posture, pilo-erection and hypoactivity. Survivors from all exposure groups recovered from these symptoms by day 12 of the study. Although some surviving animals lost bodyweight through day 7, all gained weight over the entire 14 -day observation period. Gross necropsy of the decedents revealed discoloration of the lungs, gastro-intestinal tract, liver and spleen, edema of the lungs, distention of the gastro-intestinal tract, fluid in the stomach and/or rigor mortis. Gross necropsy of the survivors from all groups was generally unremarkable. Two survivors from the group exposed to 0.52 mg/L exhibited dark red foci on the lungs.
Based on the results, the acute inhalation toxicity study defined LC50 of NaF is 1.00 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 674 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comply with the GLP as defined in 40 CFR 160: U.S EPA Good Laboratory Practice Standards: Pesticide Programs (FIFRA) and OECD Principles of Good Laboratory Practice C(81)30 (Final) Annex 2.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab animals, Scottdale, PA on May 8, 1995
- Age at study initiation: Not indicated
- Weight at study initiation: Males: 240-256 g; Females: 218-241 g
- Housing: One animal in one stainless steel cage
- Diet: Purina Rodent Chow 5012
- Water: Ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-71
- Humidity (%): Not indicated
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12/12
TEST DATES: From: 23 May 1995 - To: 6 June 1995 (14 days) - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 2 x 3 cm
- % coverage: 10% of the body surface
- Type of wrap if used: Application site covered by adhesive backed-gauze patch and held in place by plaster (strapping)
REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: No - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 10 healthy rats : 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations, weighing before application and on days 7 and 14 (termination)
- Necropsy of survivors performed: Yes
- Other examinations performed: Macroscopic abnormalities at necropsy - Statistics:
- No
- Preliminary study:
- No
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: dermal irritation and/or discoloration at the dose site One female exhibited facial staining, diarrhea and emaciation between days 2 and 6.
- Gross pathology:
- No macroscopic abnormalities
- Other findings:
- No
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material at 2000 mg/kg body weight caused transient facial staining, diarrhea and emaciation in only one of five females. All other animals appeared active and healthy. There is no need to classify or label the test material for acute dermal toxicity.
- Executive summary:
An acute dermal toxicity test was conducted with rats to determine the potential for Composite NaF, to produce toxicity after topical application. Based on the results of testing, the single dose Acute Dermal Toxicity LD50 of the test substance is greater than 2000 mg/kg of bodyweight when applied as received, moistend with distilled water.
Two thousand milligrams of the test substance per kilogram of bodyweight 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. Bodyweight 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 other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Gross necropsy findings at terminal sacrifice were generally unremarkable.
Conclusion:
The Single Dose Acute Dermal LD50 of Composite NaF is greater 2000 mg/kg of bodyweight when applied as received, moistened with distilled water.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 348 mg/kg bw
Additional information
Justification for selection of acute toxicity – oral endpoint
Key study, conducted with test substance NaF. LD50 for female rats was lower than for male rats, thus the LD50 for females is taken forward. Assuming that the driver for toxicity is the fluoride ion, the established LD50 for NaF (148.5 mg/kg) was re-calculated to KF, resulting in 248 mg/kg.
Justification for selection of acute toxicity – inhalation endpoint
Key study, conducted with test substance NaF. Assuming that the driver for toxicity is the fluoride ion, the established LC50 for NaF (1 mg/L or 1000 mg/m³) was re-calculated to KF, resulting in 1674 mg/m³.
Justification for selection of acute toxicity – dermal endpoint
Key study, conducted with test substance NaF. Assuming that the driver for toxicity is the fluoride ion, the established LD50 for NaF (> 2000 mg/kg, limit test) was re-calculated to KF, resulting in > 3348 mg/kg.
Justification for classification or non-classification
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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