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EC number: 231-954-8 | CAS number: 7782-41-4
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: NTP study
Data source
Reference
- Reference Type:
- publication
- Title:
- Technical Report on the Toxicology and Carcinogenesis Studies of Sodium Fluoride in F344/N Rats and B6C3F1 Mice.
- Author:
- NTP
- Year:
- 1 990
- Bibliographic source:
- U.S Department of Health and Human Services. NTP TR 393, NIH Publication No. 91-2848, December 1990.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
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
- Details on test material:
- No further details
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- metabolic enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver.
- Test concentrations with justification for top dose:
- Each test consisted of triplicate plates of concurrent positive and negative control and at least five doses of the test chemical. High dose was limited to 10 mg/plate.
- Vehicle / solvent:
- No vehicle
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Details on test system and experimental conditions:
- Sodium fluoride was incubated with the Salmonella typhimurium tester strains (TA98, TA100, TA1535, TA1537) either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37 degC prior to the addition of soft agar supplemented with l-histidine and d-biotin and subsequent plating on minimal glucose agar plates. Incubation continued for an additional 48 hours.
- Evaluation criteria:
- A positive response is defined as a reproducible, dose related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response was defined as an increase in revertants that was not dose related, not reproducible or of insufficient magnitude to support a determination of mutagenicity. A negative response was obtained when no increase in revertant colonies was observed following chemical treatment.
- Statistics:
- none reported.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No additional information
Any other information on results incl. tables
Mutagenicity of Sodium Fluoride in Salmonella typhimurium
|
|
Revertants/plate |
|||||
Strain |
Dose (µg/plate) |
-S9 |
+10% hamster S9 |
+10% rat S9 |
|||
Trial 1 |
Trial 2 |
Trial 1 |
Trail 2 |
Trial 1 |
Trail 2 |
||
TA100 |
0 |
70 ±5.4 |
92 ± 5.9 |
85 ±7.5 |
91 ±6.0 |
100 ±4.4 |
75 ±7.4 |
100 |
119 ±3.6 |
92 ±6.7 |
94 ±2.1 |
95 ±6.8 |
111 ±6.9 |
108 ±13.4 |
|
333 |
125 ±6.6 |
103 ±11.0 |
86 ±12.1 |
94 ±4.7 |
109 ±6.6 |
104 ±4.5 |
|
1000 |
106 ±10.1 |
84 ±3.3 |
89 ±7.1 |
89 ±7.8 |
100 ±2.2 |
94 ±5.9 |
|
3333 |
116 ±8.0 |
89 ±6.2 |
91 ±6.4 |
92 ±8.2 |
100 ±5.5 |
94 ±5.0 |
|
10000 |
114 ±1.2 |
94 ±3.3 |
85 ±7.8 |
85 ±7.2 |
97 ±8.1 |
96 ±5.4 |
|
Trial Summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive control |
318 ±21.4 |
394 ±5.7 |
428 ±22.9 |
1492 ±34.2 |
234 ±10.5 |
684 ±44.0 |
|
TA1535 |
0 |
19 ±2.3 |
8 ±0.6 |
5 ±0.6 |
6 ±0.7 |
12 ±1.8 |
7 ±0.9 |
100 |
24 ±3.8 |
10 ±2.1 |
11 ±3.2 |
9 ±2.3 |
13 ±1.8 |
7 ±1.0 |
|
333 |
20 ±5.2 |
7 ±0.9 |
10 ±0.3 |
8 ±2.6 |
12 ±2.1 |
7 ±1.5 |
|
1000 |
21 ±3.5 |
9 ±2.3 |
11 ±1.7 |
8 ±3.2 |
9 ±1.3 |
8 ±0.0 |
|
3333 |
24 ±2.6 |
8 ±2.8 |
9 ±1.7 |
8 ±0.9 |
12 ±2.1 |
7 ±1.0 |
|
10000 |
24 ±0.0 |
8 ±1.3 |
7 ±0.7 |
4 ±0.7 |
12 ±3.2 |
10 ±2.7 |
|
Trial Summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive control |
216 ±8.2 |
244 ±5.8 |
293 ±11.9 |
274 ±6.9 |
155 ±7.6 |
189 ±7.5 |
|
TA1537 |
0 |
6 ±1.3 |
7 ±1.5 |
5 ±0.6 |
6 ±1.0 |
16 ±1.2 |
6 ±0.9 |
100 |
5 ±1.5 |
6 ±0.3 |
21 ±2.9 |
7 ±1.9 |
16 ±0.9 |
11 ±3.0 |
|
333 |
8 ±1.5 |
4 ±0.9 |
15 ±1.5 |
6 ±0.6 |
15 ±3.2 |
9 ±2.5 |
|
1000 |
7 ±0.9 |
6 ±1.9 |
15 ±2.0 |
7 ±0.7 |
17 ±4.3 |
5 ±1.5 |
|
3333 |
6 ±1.2 |
4 ±1.8 |
15 ±2.1 |
7 ±1.2 |
15 ±1.5 |
6 ±1.5 |
|
10000 |
8 ±0.6 |
4 ±0.6 |
14 ±2.8 |
4 ±0.3 |
15 ±1.2 |
7 ±0.7 |
|
Trial Summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive control |
59 ±2.0 |
107 ±41.0 |
113 ±6.2 |
464 ±28.0 |
239 ±35.2 |
251 ±18.4 |
|
TA98 |
0 |
17 ±1.2 |
14 ±2.1 |
40 ±12.5 |
22 ±3.4 |
25 ±2.2 |
26 ±3.2 |
100 |
20 ±3.8 |
13 ±3.2 |
34 ±2.7 |
19 ±0.9 |
43 ±3.8 |
32 ±3.2 |
|
333 |
18 ±0.3 |
14 ±3.2 |
38 ±4.0 |
21 ±4.6 |
38 ±3.8 |
23 ±2.2 |
|
1000 |
16 ±0.3 |
11 ±2.8 |
30 ±1.7 |
16 ±3.2 |
35 ±1.8 |
21 ±2.0 |
|
3333 |
23 ±2.2 |
10 ±2.5 |
33 ±2.3 |
25 ±2.9 |
27 ±0.9 |
15 ±1.5 |
|
10000 |
19 ±2.6 |
12 ±1.3 |
29 ±7.0 |
17 ±0.3 |
32 ±2.1 |
18 ±1.0 |
|
Trial Summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive control |
504 ±20.3 |
684 ±9.8 |
265 ±3.8 |
638 ±104.1 |
146 ±5.2 |
180 ±10.4 |
Applicant's summary and conclusion
- Conclusions:
- Sodium fluoride did not induce gene mutations in Salmonella typhimurium when tested with a preincubation protocol at doses of 100 to 10,000 µg/plate in strains TA100, TA1535, TA1537 and TA98
- Executive summary:
Sodium fluoride did not induce gene mutations in Salmonella typhimurium when tested with a preincubation protocol at doses of 100 to 10,000 µg/plate in strains TA100, TA1535, TA1537 and TA98; all strains were tested with and without Aroclor 1254 -induced male Sprague-Dawley rat or Syrian hamster liver S9.
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