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EC number: 232-007-1 | CAS number: 7783-54-2
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 May 2012 to 27 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and TG compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Nitrogen trifluoride
- EC Number:
- 232-007-1
- EC Name:
- Nitrogen trifluoride
- Cas Number:
- 7783-54-2
- Molecular formula:
- F3N
- IUPAC Name:
- trifluoroamine
- Test material form:
- gas
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital / 5,6-benzoflavone induced rat liver
- Test concentrations with justification for top dose:
- First test: 0, 1.56, 3.13, 6.25, 12.5, 25, 50 and 100% (v/v)
Second test: 0, 6.25, 12.5, 25, 50 and 100% (v/v)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: dichloromethane (-S9); vinyl chloride monomer (+S9)
- Details on test system and experimental conditions:
- Initial toxicity-mutation assay:
The five tester strains were exposed toNF3 in stainless steel vessels at 7 concentrations (see above).
Aliquots (0.1 mL) of a 10 hour bacterial culture and 10% S9 mix (0.5 mL) or 0.1M pH 7.4 phosphate buffer (0.5 mL) were placed in glass vessels and 2 mL of agar containing histidine (0.5 mM), biotin (0.5 mM) and tryptophan (0.5 mM) were added. The mixtures were thoroughly shaken and overlaid onto previously prepared Petri dishes containing approximately 25 mL minimal agar. Each Petri dish was individually labelled with a unique code, identifying the contents of the dish. Three Petri dishes were prepared for each dose level. Plates were also prepared without the addition of bacteria in order to assess the sterility of the test substance, S9 mix and phosphate buffer. The seeded plates were placed in stainless steel vessels. The plates were supported, inverted with lids removed, on stainless steel racks inside the vessels, so as to permit circulation of the test substance. Plates containing S9 mix and buffer were placed in separate vessels. The vessels were sealed and partially evacuated. Appropriate volumes of the test substance or vapour-phase positive controls were injected via a needle valve or septum. The vessels were warmed to 37°C and the contents equilibrated to atmospheric pressure, where necessary, by admitting sterile atmospheric air. The plates were incubated for ca 48 hours in the vessels at 37°C and then removed from the vessels under air extraction. The plates were incubated for a further period ofca. 24 hours at 37°C to permit the growth of revertant colonies. Further sets of plates were prepared for the liquid positive control compounds. Aliquots of 0.1 mL of the positivecontrol solutions were added to the plates together with the bacteria, buffer or S9 mix andagar overlay. These plates were incubated at 37°C for 48-72 hours (not in stainless steel vessels). After this period the appearance of the background bacterial lawn was examined and revertant colonies were counted using an automated colony counter (Perceptive Instruments Sorcerer).
Any toxic effects of the test substance would be detected by a substantial (ca. 50%) reduction in revertant colony counts or by the absence of a complete background bacterial lawn. In the absence of any toxic effects the maximum concentration used in the second test was the same as that used in the first. If toxic effects had been observed at more than one concentration, a lower concentration might be chosen, ensuring that signs of bacterial inhibition are present at this maximum concentration. Ideally a minimum of four non-toxic concentrations should beobtained.
Confirmatory mutagenicity assay:
The second test was conducted using exactly the same procedures as the first test. The maximum test substance concentration chosen was again 100% v/v (nominal), but only five concentrations were used. - Evaluation criteria:
- If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive concentration-response relationship, it is considered to exhibit mutagenic activity in this test system.
Toxicity was assessed by reduction in the background lawn; dose-dependent reduction in the mutant count/plate (concurrent vehicle control). - Statistics:
- No statistical analysis was performed on the data.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: TA100, TA1535, WP2uvrA (pKM101)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: TA98 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Six doses of the test material ranging from 16 to 5000 ug/plate±S9 were evaluated in the plate incorporation test. No precipitation or toxicity was observed up to the limit dose, 5000 ug/plate.
No evidence of toxicity was observed in either the presence or absence of S9 in either test.
Any other information on results incl. tables
INITIAL TOXICITY-MUTATION ASSAY:
Table 7.6.1 -1: Bacterial mutation assay, summary of results– first test
Dose (%) |
0 |
1.56 |
3.13 |
6.25 |
12.5 |
25 |
50 |
100 |
+ve controla |
REVERTANTS/PLATE –S9 |
|||||||||
TA98 |
27.7 ± 4.2 |
26.0 ± 2.6 |
27.3 ± 0.6 |
23.3 ± 6.0 |
28.7 ± 2.1 |
29.0 ± 3.5 |
27.7 ± 1.5 |
25.7 ± 2.5 |
374.0 ± 47.9 |
TA100 |
121.7 ± 12.3 |
104.0 ± 2.6 |
127.3 ± 11.9 |
115.3 ± 19.3 |
110.0 ± 3.5 |
138.3 ± 10.5 |
169.7 ± 11.9 |
385.7 ± 11.1 |
1004.7 ± 19.1 |
TA1535 |
23.3 ± 0.6 |
24.3 ± 2.5 |
25.7 ± 4.7 |
30.3 ± 3.1 |
37.0 ± 2.6 |
67.7 ± 5.9 |
124.7 ± 10.6 |
247.7 ± 15.6 |
909.3 ± 175.2 |
TA1537 |
10.3 ± 1.5 |
12.7 ± 2.1 |
13.0 ± 1.7 |
11.0 ± 4.6 |
10.0 ± 1.0 |
9.7 ± 0.6 |
9.3 ± 3.1 |
15.3 ± 3.8 |
571.3 ± 114.6 |
WP2uvrA |
134.7 ± 5.8 |
137.3 ± 1.5 |
148.3 ± 11.0 |
162.7 ±5.9 |
167.7 ± 8.5 |
212.3 ± 9.0 |
357.7 ± 29.3 |
708.3 ± 32.1 |
2047.0 ± 210.5 |
REVERTANTS/PLATE +S9 |
|||||||||
TA98 |
36.7 ± 1.5 |
39.7 ± 3.1 |
40.0 ± 5.2 |
37.7 ± 1.2 |
36.0 ± 1.7 |
39.7 ± 2.1 |
37.3 ± 2.1 |
34.3 ± 7.4 |
338.7 ± 8.6 |
TA100 |
125.3 ± 9.3 |
135.0 ± 1.7 |
163.3 ± 11.0 |
213.3 ± 20.3 |
307.3 ± 5.7 |
520.7 ± 4.9 |
599.0 ± 21.6 |
595.3 ± 39.2 |
1254.7 ± 118.3 |
TA1535 |
21.0 ± 0.0 |
24.7 ± 1.2 |
62.3 ± 8.7 |
169.7 ± 11.1 |
211.3 ± 24.3 |
239.0 ± 7.0 |
303.0 ± 5.3 |
313.0 ± 6.9 |
245.7 ± 43.9 |
TA1537 |
27.0 ± 0.0 |
22.0 ± 4.6 |
25.3 ± 2.3 |
26.7 ± 2.5 |
25.7 ± 1.5 |
23.3 ± 2.3 |
25.3 ± 3.2 |
23.0 ± 1.0 |
183.0 ± 7.9 |
WP2uvrA |
151.3 ± 9.1 |
150.7 ± 6.7 |
184.0 ± 18.0 |
214.7 ± 16.3 |
339.3 ± 13.6 |
406.0 ± 12.1 |
484.7 ± 14.6 |
402.0 ± 60.6 |
2258.7 ± 113.9 |
a – standard liquid positive controls were used; the dose for these therefore was ug/plate
Table 7.6.1 -2: Bacterial mutation assay, summary of results– second test
Dose (%) |
0 |
6.25 |
12.5 |
25 |
50 |
100 |
+ve controla |
REVERTANTS/PLATE –S9 |
|||||||
TA98 |
34.7 ± 0.6 |
27.3 ± 7.1 |
26.3 ± 2.1 |
24.7 ± 2.9 |
31.7 ± 9.3 |
26.0 ± 1.7 |
383.7 ± 11.6
|
TA100 |
129.3 ± 2.3 |
135.7 ± 4.9 |
148.7 ± 10.1 |
186.3 ± 6.7 |
374.3 ± 27.0 |
489.0 ± 76.2 |
1052.3 ± 40.5 |
TA1535 |
20.7 ± 2.5 |
26.0 ± 5.0 |
32.3 ± 4.5 |
60.7 ± 6.5 |
146.0 ± 42.3 |
237.0 ± 24.6 |
849.3 ± 200.7 |
TA1537 |
13.0 ± 0.0 |
10.7 ± 1.5 |
12.7 ± 3.1 |
10.0 ± 1.0 |
11.3 ± 0.6 |
12.3 ± 3.2 |
702.0 ± 103.1 |
WP2uvrA |
134.7 ± 13.6 |
171.0 ± 20.7 |
193.0 ± 7.0 |
254.0 ± 11.8 |
404.0 ± 20.1 |
878.7 ± 66.1 |
2510.3 ± 355.3 |
REVERTANTS/PLATE +S9 |
|||||||
TA98 |
40.0 ± 4.4 |
41.0 ± 6.6 |
37.0 ± 3.0 |
35.7 ± 2.1 |
39.3 ± 3.2 |
30.7 ± 1.5 |
361.7 ± 29.2 |
TA100 |
122.0 ± 8.5 |
248.7 ± 16.6 |
352.3 ± 34.1 |
434.3 ± 13.8 |
583.0 ± 22.5 |
624.7 ± 19.6 |
889.0 ± 33.4 |
TA1535 |
22.3 ± 1.2 |
161.3 ± 17.1 |
252.7 ± 10.1 |
303.0 ± 21.0 |
348.3 ± 20.6 |
396.3 ± 9.1 |
224.0 ± 19.0 |
TA1537 |
20.7 ± 1.2 |
27.0 ± 1.0 |
28.7 ± 4.6 |
31.0 ± 4.6 |
31.7 ± 8.7 |
24.0 ± 3.6 |
170.3 ± 7.1 |
WP2uvrA |
147.0 ± 7.9 |
245.0 ± 2.6 |
392.7 ± 3.8 |
441.7 ± 4.9 |
479.0 ± 8.7 |
430.3 ± 17.6 |
2140.7 ± 109.5 |
Table 7.6.1 -3: Bacterial mutation assay, summary of gaseous positive controls – first and second test
Dose (%) |
Positive control |
Revertants / plate |
|
1st test |
2nd test |
||
TA98 – S9 |
DCM |
120.0 ± 13.1 |
366.7 ± 44.5 |
TA100 – S9 |
DCM |
597.7 ± 66.2 |
794.7 ± 42.0 |
TA100 |
VCM |
393.7 ± 35.2 |
417.0 ± 41.3 |
TA1535 |
VCM |
136.3 ± 5.5 |
161.0 ± 4.4 |
WP2uvrA |
VCM |
808.0 ± 22.9 |
855.0 ± 70.8 |
DCM - dichloromethane
VCM – vinyl chloride monomer
Applicant's summary and conclusion
- Conclusions:
- It was concluded that NF3 showed evidence of mutagenic activity in this bacterial system with increases in revertants observed in twoSalmonella typhimuriumstrains (TA100 and TA1535) and oneEscherichia colistrain (WP2uvrA(pKM101)) in the absence and presence of metabolic activation. In the remaining two Salmonella typhimurium strains (TA98 and TA1537) in the absence and presence of metabolic activation no evidence of mutagenic activity was observed when tested up to the maximum practicable concentration (100% v/v), under the test conditions employed.
- Executive summary:
In a reverse gene mutation assay in bacteria, fiveSalmonella typhimuriumstrains (TA98, TA100, TA1535, and TA1537) and oneE.coli(WP2uvrA(pKM101) were exposed to NF3 gas diluted in atmospheric air. Atmospheric air was also used as a vehicle control. To confirm sensitivity of the test system standard liquid positive controls were along with gaseous positive controls (dichloromethane in the absence of S9 and vinyl chloride monomer).
Concentrations of NF3 up to 100% (v/v) were tested (the maximum practicable concentration).
No signs of toxicity were observed towards the tester strains in either mutation test following exposure toNF3.
In both mutation tests in the absence of S9 mix, substantial, concentration-related increases in revertant colony counts were obtained in strains TA1535 and WP2uvrA (pKM101). Smaller increases were obtained in strain TA100.
In both mutation tests in the presence of S9 mix, substantial, concentration-related increases in revertant colony counts were obtained in strains TA1535 and TA100. Smaller increaseswere obtained in strain WP2uvrA (pKM101).
These data suggest that NF3 is mutagenic in bacteria, inducing base changes. The effect of metabolic activation did not alter the mutagenic potential in these strains.
It was concluded that NF3 showed evidence of mutagenic activity in this bacterial system with increases in revertants observed in twoSalmonella typhimuriumstrains (TA100 and TA1535) and oneEscherichia colistrain (WP2uvrA(pKM101)) in the absence and presence of metabolic activation. In the remaining two Salmonella typhimurium strains (TA98 and TA1537) in the absence and presence of metabolic activation no evidence of mutagenic activity was observed when tested up to the maximum practicable concentration (100% v/v), under the test conditions employed.
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