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EC number: 232-029-1 | CAS number: 7783-82-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study reviewed by the United States Governmental Organisation "NATIONALTOXICOLOGY PROGRAM" (NTP), U.S. DEPARTMENT OF HEALTH AND HUMANSERVICES, PublicHealthService, National Institutes of Health.Therefore it is consired as reasonably reliable. Study done according to OECD Guideline. Read across justification is given in section 13 assessment reports: WF6 justification for read across
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male Fischer 344 rat liver Sa
- Test concentrations with justification for top dose:
- Two laboratories performed the test. The highest dose of the study compound did not exceed 5 mg/mL.
- Vehicle / solvent:
- none
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Details on test system and experimental conditions:
- Mouse lymphoma L5178Y cells were maintained at 37 °C as suspension cultures in Fischer's medium supplemented with 2 mM l-glutamine, 110 µg/mL sodium pyruvate, 0.05% pluronic F68, antibiotics and heat activated horse serum. To reduce the number of spontaneously occurring trifluorothymidine (TFT) resistant cells, subcultures were exposed once to medium containing THMG (thymidine, hypoxanthine, methotrexate, glycine) for one day, to THG for one day and to normal medium for 3 to 5 days.
Incubation with the study chemical continued for 4 hours, at which time the medium plus chemical was removed. The cells were resuspended in fresh medium and incubated for an additional 2 days to allow expression of the mutant phenotype. Cell density was monitored so that log phase growth was maintained. After the 48 hour expression period, 3 x 10(+6) cells were plated in medium and soft agar supplemented with trifluorothymidine for selection of TFT-resistant cells and 600 cells were plated in nonselective medium and soft agar to determine cloning efficiency. Plates were incubated at 37 °C in 5% carbon dioxide for 10 to 12 days. - Evaluation criteria:
- All data was evaluated statistically for both trend and peak response. Both responses had to be significant (P<0.05) for a chemical to be considered positive and the absence of both trend and a peak response resulted in a negative call. Validation criteria are detailed in Myhr at al (1985). This assay is initially performed without S9; if a clearly positive response is not obtained, the experiment is repeated with induced S9.
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Sodium fluoride was studied at two laboratories for induction of trifluorothymidine resistance in mouse L5178Y lymphoma cells. In the first laboratory, sodium fluoride was positive both with and without Aroclor 1254-induced male Fischer 344 rat liver S9, the effective doses, with and without S9, ranged from 300 to 600 µg/mL (Caspary et al, 1987). In the second laboratory, sodium fluoride was tested without S9 only, and test results were positive in the first trial at 62.5, 125, and 1,000 µg/mL and in the second trial at 800 and 900 µg/mL. The mutant colonies obtained after sodium fluoride treatment of L5178Y cells were primarily small colonies, suggesting that chromosomal abnormalities may be involved.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
positive
In two laboratories, sodium fluoride was tested for induction of trifluorothymidine resistance in mouse L5178Y lymphoma cells; results were positive both with and without S9. - Executive summary:
Sodium fluoride was studied at two laboratories for induction of trifluorothymidine resistance in mouse L5178Y lymphoma cells. In the first laboratory, sodium fluoride was positive both with and without Aroclor 1254-induced male Fischer 344 rat liver S9, the effective doses, with and without S9, ranged from 300 to 600 µg/mL (Caspary et al, 1987). In the second laboratory, sodium fluoride was tested without S9 only, and test results were positive in the first trial at 62.5, 125, and 1,000 µg/mL and in the second trial at 800 and 900 µg/mL. The mutant colonies obtained after sodium fluoride treatment of L5178Y cells were primarily small colonies, suggesting that chromosomal abnormalities may be involved.
Reference
The table below shows the induction of trifluorothymidine resistance in mouse L5178Y cells by sodium fluoride; | |||||
Compound | Concentration (µg/mL) | Cloning Efficiency (%) | Relative Total Growth (%) | Tft Resistant Cells | Mutant fraction |
- S9 | 75.8 ±3.8 | 99.8 ±4.8 | 67.0 ±5.9 | 29.5 ±1.9 | |
Trial 1 | |||||
Distilled water | |||||
Sodium fluoride | 200 | 85.5 ±18.5 | 81.5 ±8.5 | 80.5 ±13.5 | 32.0 ±2.0 |
300 | 85.3 ±4.7 | 72.0 ±5.2 | 133.3 ±22.3 | 52.7 ±9.4 | |
400 | 78.7 ±0.9 | 41.0 ±4.0 | 107.7 ±4.9 | 45.7 ±1.9 | |
500 | 75.0 ±3.8 | 16.7 ±2.7 | 125.0 ±16.7 | 55.3 ±4.8 | |
600 | 79.5 ±3.5 | 10.0 ±1.0 | 196.0 ±3.0 | 83.0 ±5.0 | |
800 | Lethal | ||||
Methyl methanesulfonate | 5 | 66.7 ±2.4 | 70.7 ±5.2 | 489.0 ±43.7 | 244.3 ±13.2 |
- S9 | 105.7 ±9.1 | 100.0 ±9.1 | 77.0 ±2.5 | 24.3 ±1.9 | |
Trial 2 | |||||
Distilled water | |||||
Sodium fluoride | 50 | 91.0 ±7.0 | 86.3 ±2.0 | 59.0 ±9.3 | 22.0 ±3.1 |
100 | 92.0 ±4.0 | 71.5 ±8.5 | 75.5 ±3.5 | 27.0 ±0 | |
200 | 88.0 ±4.6 | 57.0 ±2.3 | 72.7 ±11.1 | 27.3 ±3.0 | |
300 | 89.3 ±10.2 | 49.3 ±3.7 | 58.3 ±8.7 | 22.0 ±2.7 | |
400 | 104.0 ±12.0 | 40.0 ±0.0 | 112.0 ±25.0 | 35.5 ±4.5 | |
500 | 94.3 ±7.6 | 17.3 ±3.0 | 119.0 ±28.4 | 41.3 ±8.5 | |
600 | Lethal | ||||
Methyl methanesulfonate | 5 | 66.7 ±2.4 | 70.7 ±5.2 | 489.0 ±43.7 | 140 ±36.5 |
+ S9 | 107.5 ±1.3 | 100.0 ±6.8 | 83.8 ±6.9 | 25.8 ±2.1 | |
Trial 3 | |||||
Distilled water | |||||
Sodium fluoride | 100 | 85 | 75 | 66 | 26 |
200 | 99.7 ±7.8 | 70.7 ±4.9 | 59.7 ±9.9 | 20.7 ±4.4 | |
300 | 94.5 ±5.5 | 52.0 ±9.0 | 110.5 ±5.5 | 39.5 ±4.5 | |
400 | 106.7 ±7.0 | 41.3 ±2.3 | 121 ±14.1 | 39.0 ±7.6 | |
500 | 72.3 ±9.2 | 13.3 ±3.8 | 177.7 ±45.1 | 81.0 ±19.3 | |
600 | 77.5 ±13.5 | 7.5 ±0.5 | 206.5 ±24.5 | 94.0 ±27.0 | |
Methyl methanesulfonate | 2.5 | 61.3 ±5.2 | 28.0 ±2.1 | 615.0 ±43.3 | 334.7 ±11.9 |
+ S9 | 82.3 ±3.0 | 100.0 ±9.3 | 81.5 ±8.7 | 33.0 ±2.4 | |
Trial 3 | |||||
Distilled water | |||||
Sodium fluoride | 50 | 78.0 ±2.9 | 100.0 ±7.8 | 63.7 ±4.2 | 27.0 ±1.2 |
100 | 79.3 ±6.0 | 86.7 ±21.1 | 88.7 ±14.0 | 37.7 ±6.8 | |
200 | 85.0 ±13.1 | 83.3 ±6.4 | 98.0 ±18.6 | 38.0 ±2.0 | |
300 | 76.3 ±0.3 | 49.7 ±3.3 | 119.0 ±11.8 | 51.7 ±5.2 | |
400 | 77.3 ±3.8 | 29.0 ±1.5 | 144.7 ±10.3 | 62.3 ±2.3 | |
500 | 74.3 ±3.4 | 21.0 ±3.1 | 167.7 ±27.9 | 75.7 ±14.3 | |
600 | Lethal | ||||
Methyl methanesulfonate | 2.5 | 47.7 ±2.7 | 21.0 ±2.7 | 731.7 ±22.9 | 573.7 ±34.6 |
The table below shows the results obtained for the induction of trifluorothymidine resistance in mouse L5178Y/TK cells by sodium fluoride; | |||||
Compound | Concentration (µg/mL) | Cloning Efficiency (%) | Relative Total Growth (%) | Tft Resistant Cells | Mutant fraction |
- S9 | 58.8 ±3.0 | 100.0 ±10.3 | 101 ±14.0 | 58.0 ±9.7 | |
Trial 1 | |||||
Fischer’s medium without serum | |||||
Sodium fluoride | 62.5 | 52.5 ±5.5 | 88.5 ±12.5 | 162.0 ±0.0 | 104.5 ±11.5 |
125 | 52.5 ±8.5 | 78.0 ±4.0 | 144.0 ±24.0 | 97.5 ±31.5 | |
250 | 59.0 ±4.0 | 70.0 ±9.0 | 130.0 ±9.0 | 73.5 ±0.5 | |
500 | 70.0 ±15.0 | 36.0 ±1.0 | 161.5 ±18.5 | 82.5 ±26.5 | |
1000 | 40.0 ±4.0 | 8.0 ±3.0 | 155.5 ±13.5 | 134.0 ±25.0 | |
Methyl methanesulfonate | 15 | 16.5 ±1.5 | 13.0 ±2.0 | 172.0 ±3.0 | 342.5 ±24.5 |
- S9 | 90.5 ±5.72 | 100.0 ±5.3 | 138.3 ±12.8 | 51.0 ±4.1 | |
Trial 2 | |||||
Fischer's medium without serum | |||||
Sodium fluoride | 500 | 82.0 ±3.0 | 33.0 ±0.0 | 145.0 ±20.0 | 58.5 ±5.5 |
600 | 87.0 ±10.0 | 28.0 ±3.0 | 148.5 ±0.5 | 58.0 ±7.0 | |
700 | 90.5 ±3.5 | 25.0 ±0.0 | 177.0 ±25.0 | 66.0 ±12.0 | |
800 | 78.5 ±0.5 | 20.0 ±1.0 | 215.5 ±22.5 | 91.5 ±9.5 | |
900 | 78.0 ±2.0 | 13.0 ±1.0 | 445.0 ±22.0 | 195.5 ±3.5 | |
1000 | Lethal | ||||
Methyl methanesulfonate | 1552.0 ±4.0 | 52.0 ±4.0 | 35.0 ±1.0 | 77.0 ±14.0 | 49.0 ±5.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
Justification for selection of genetic toxicity endpoint
Study reviewed by the United States Governmental Organisation "NATIONALTOXICOLOGY PROGRAM" (NTP), U.S. DEPARTMENT OF HEALTH AND HUMANSERVICES, PublicHealthService, National Institutes of Health.Therefore it is consired as reasonably reliable. Study done according to OECD Guideline.
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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