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EC number: 233-433-0 | CAS number: 10163-15-2
- 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:
- The experimental phase of this study was performed between 26 January 2010 and 10 February 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study is conducted according to an appropriate guideline and under the conditions of GLP, the study is therefore considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- Meets the requirements of the Japanese Regulatory Authorities including METI, MHLW and MAFF, OECD Guidelines for Testing of Chemicals No. 471 "and the USA, EPA (TSCA) OPPTS harmonised guidelines.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of GLP inspection: 15 September 2009. Date of signature on GLP certificate: 26 November 2009.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Disodium fluorophospahte
- IUPAC Name:
- Disodium fluorophospahte
- Reference substance name:
- Disodium fluorophosphate
- EC Number:
- 233-433-0
- EC Name:
- Disodium fluorophosphate
- Cas Number:
- 10163-15-2
- Molecular formula:
- FH2O3P.2Na
- IUPAC Name:
- disodium fluorophosphate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor’s identification:Disodium fluorophosphate
Description : White solid
Batch number :9-01941-56
Date received :12 August 2009
Expiry date :January 2011
Storage conditions:Room temperature in the dark over silica gel
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine for Salmonella.
Tryptophan for E.Coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone/betanaphthoflavone induced rat liver, S9
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Experiment one (range-finding test): 50, 150, 500, 1500 and 5000 µg/plate
Experiment two (main test): 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile distilled water.
- Justification for choice of solvent/vehicle: The test material was fully soluble in sterile distilled water at 50 mg/ml in solubility checks performed in-house.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA100
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 1 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1535
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 2 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1537
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 2 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of WP2uvrA
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 10 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix Migrated to IUCLID6: Benzo(a)pyrene: 5 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix Migrated to IUCLID6: 4-Nitroquinoline-1-oxide: 0.2 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1537
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix Migrated to IUCLID6: 9-Aminoacridine: 80 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA100
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9 mix Migrated to IUCLID6: N-ethyl-N'-nitro-N-nitrosoguanidine: 3 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1535
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix Migrated to IUCLID6: N-ethyl-N'-nitro-N-nitrosoguanidine: 5 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of WP2uvrA
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix Migrated to IUCLID6: N-ethyl-N'-nitro-N-nitrosoguanidine: 2 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period for bacterial strains: 10h
- Exposure duration: 48 - 72 hrs
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): Not applicable
NUMBER OF REPLICATIONS: Triplicate plating.
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn. - Evaluation criteria:
- Acceptance Criteria:
The reverse mutation assay may be considered valid if the following criteria are met:
All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
The appropriate characteristics for each tester strain have been confirmed, eg rfa cell-wall mutation and pKM101 plasmid R-factor etc.
All tester strain cultures should be in the approximate range of 1 to 9.9 x 109 bacteria per ml.
Each mean positive control value should be at least twice the respective vehicle control value for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains to mutagenic exposure and the integrity of the S9-mix.
There should be a minimum of four non-toxic test material dose levels.
There should not be an excessive loss of plates due to contamination.
Evaluation criteria:
There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods, as recommended by the UKEMS can also be used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit a definitive judgement about the test material activity. Results of this type will be reported as equivocal. - Statistics:
- Standard deviation
Dunnett's Linear Regression Analysis
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Tested up to maximum recommended dose of 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- 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 nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Tested up to maximum recommended dose of 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test material was fully soluble in sterile distilled water at 50 mg/ml in solubility checks performed in-house.
- Precipitation: No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
RANGE-FINDING/SCREENING STUDIES:
Preliminary Toxicity Test:
The test material was non-toxic to the strains of bacteria used (TA100 and WP2uvrA-). The test material formulation and S9-mix used in this experiment were both shown to be sterile.
COMPARISON WITH HISTORICAL CONTROL DATA:
Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory).
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
ADDITIONAL INFORMATION ON CYTOTOXICITY: None - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
RESULTS
Preliminary ToxicityTest
The test material was non-toxic to the strains of bacteria used (TA100 and WP2uvrA-). The test material formulation and S9-mix used in this experiment were both shown to be sterile.
The numbers of revertant colonies for the toxicity assay were:
With (+) or without (-) S9-mix |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
116 |
104 |
112 |
93 |
135 |
115 |
119 |
116 |
108 |
119 |
123 |
+ |
TA100 |
101 |
118 |
109 |
118 |
105 |
105 |
109 |
98 |
101 |
103 |
127 |
- |
WP2uvrA- |
24 |
31 |
25 |
41 |
25 |
25 |
26 |
20 |
20 |
25 |
28 |
+ |
WP2uvrA- |
25 |
24 |
26 |
21 |
18 |
24 |
29 |
29 |
25 |
29 |
28 |
MutationTest
Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). These data are not given in the report. The amino acid supplemented top agar and the S9-mix used in both experiments was shown to be sterile.
Results for the negative controls (spontaneous mutation rates) are presented inTable1and were considered to be acceptable. These data are for concurrent untreated control plates performed on the same day as the Mutation Test.
The individual plate counts, the mean number of revertant colonies and the standard deviations for the test material, vehicle and positive controls both with and without metabolic activation, are presented in Table 2 to Table 5.
Information regarding the equipment and methods used in these experiments as required by the Japanese Ministry of Economy, Trade and Industry and Japanese Ministry of Health, Labour and Welfare and graphs are presented in Overall remarks, attachments.
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
Table1 Spontaneous Mutation Rates (Concurrent Negative Controls
Range-finding Test
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||
100 |
|
20 |
|
21 |
|
22 |
|
5 |
|
102 |
(101) |
18 |
(19) |
16 |
(20) |
22 |
(22) |
7 |
(7) |
100 |
|
18 |
|
24 |
|
21 |
|
9 |
|
Main Test
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|||||
79 |
|
9 |
|
19 |
|
24 |
|
11 |
|
98 |
(93) |
12 |
(11) |
23 |
(20) |
10 |
(18) |
9 |
(11) |
102 |
|
12 |
|
18 |
|
19 |
|
12 |
|
Table2 Test Results: Range-Finding Test– Without Metabolic Activation
Test Period |
From: 02 February 2010 |
To: 05 February 2010 |
||||||||||
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||||||||
Base-pair substitution type |
Frameshift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA‑ |
TA98 |
TA1537 |
||||||||
- |
0 |
123 89 110 |
(107) 17.2# |
15 24 24 |
(21) 5.2 |
25 24 24 |
(24) 0.6 |
19 18 15 |
(17) 2.1 |
9 11 15 |
(12) 3.1 |
|
- |
50 |
104 86 97 |
(96) 9.1 |
21 25 17 |
(21) 4.0 |
20 25 25 |
(23) 2.9 |
20 16 15 |
(17) 2.6 |
12 8 11 |
(10) 2.1 |
|
- |
150 |
100 104 115 |
(106) 7.8 |
19 25 18 |
(21) 3.8 |
24 25 17 |
(22) 4.4 |
16 24 18 |
(19) 4.2 |
11 11 11 |
(11) 0.0 |
|
- |
500 |
86 95 105 |
(95) 9.5 |
24 22 24 |
(23) 1.2 |
22 22 19 |
(21) 1.7 |
18 17 24 |
(20) 3.8 |
13 6 9 |
(9) 3.5 |
|
- |
1500 |
95 98 92 |
(95) 3.0 |
22 24 24 |
(23) 1.2 |
25 25 25 |
(25) 0.0 |
18 24 20 |
(21) 3.1 |
7 15 15 |
(12) 4.6 |
|
- |
5000 |
108 111 83 |
(101) 15.4 |
20 26 27 |
(24) 3.8 |
18 18 19 |
(18) 0.6 |
21 20 22 |
(21) 1.0 |
11 13 10 |
(11) 1.5 |
|
Positive controls
S9-Mix
- |
Name Concentration (μg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
||||||
3 |
5 |
2 |
0.2 |
80 |
||||||||
552 593 439 |
(528) 79.8 |
436 460 470 |
(455) 17.5 |
645 681 685 |
(670) 22.0 |
152 154 149 |
(152) 2.5 |
735 691 703 |
(710) 22.7 |
ENNG N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
# Standard deviationTable3 Test Results: Range-Finding Test– With Metabolic Activation
Test Period |
From: 02 February 2010 |
To: 05 February 2010 |
||||||||||
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||||||||
Base-pair substitution type |
Frameshift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA‑ |
TA98 |
TA1537 |
||||||||
+ |
0 |
96 82 83 |
(87) 7.8# |
18 14 15 |
(16) 2.1 |
19 25 19 |
(21) 3.5 |
24 25 25 |
(25) 0.6 |
11 10 15 |
(12) 2.6 |
|
+ |
50 |
83 84 88 |
(85) 2.6 |
19 14 16 |
(16) 2.5 |
21 18 20 |
(20) 1.5 |
22 24 27 |
(24) 2.5 |
10 10 11 |
(10) 0.6 |
|
+ |
150 |
95 95 78 |
(89) 9.8 |
12 15 13 |
(13) 1.5 |
25 15 27 |
(22) 6.4 |
17 26 27 |
(23) 5.5 |
9 11 10 |
(10) 1.0 |
|
+ |
500 |
86 85 85 |
(85) 0.6 |
17 18 14 |
(16) 2.1 |
18 17 18 |
(18) 0.6 |
16 24 21 |
(20) 4.0 |
7 14 11 |
(11) 3.5 |
|
+ |
1500 |
97 90 83 |
(90) 7.0 |
14 15 15 |
(15) 0.6 |
20 19 19 |
(19) 0.6 |
18 18 17 |
(18) 0.6 |
6 14 7 |
(9) 4.4 |
|
+ |
5000 |
91 93 90 |
(91) 1.5 |
15 19 15 |
(16) 2.3 |
26 26 28 |
(27) 1.2 |
25 21 22 |
(23) 2.1 |
8 17 18 |
(14) 5.5 |
|
Positive controls
S9-Mix
+ |
Name Concentration (μg/plate) No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
||||||
1 |
2 |
10 |
5 |
2 |
||||||||
1188 1298 1294 |
(1260) 62.4 |
252 225 227 |
(235) 15.0 |
421 440 391 |
(417) 24.7 |
194 188 138 |
(173) 30.7 |
244 214 222 |
(227) 15.5 |
BP Benzo(a)pyrene
2AA 2-Aminoanthracene
# Standard deviationTable4 Test Results: Main Test– Without Metabolic Activation
Test period |
From: 07 February 2010 |
To: 10 February 2010 |
|||||||||||||
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||||||
Base-pair substitution type |
Frameshift type |
||||||||||||||
TA100 |
TA1535 |
WP2uvrA‑ |
TA98 |
TA1537 |
|||||||||||
- |
0 |
91 87 98 |
(92) 5.6# |
13 21 23 |
(19) 5.3 |
29 18 19 |
(22) 6.1 |
19 22 18 |
(20) 2.1 |
10 20 13 |
(14) 5.1 |
||||
- |
50 |
107 100 98 |
(102) 4.7 |
16 21 31 |
(23) 7.6 |
24 14 26 |
(21) 6.4 |
12 23 20 |
(18) 5.7 |
19 12 23 |
(18) 5.6 |
||||
- |
150 |
100 91 90 |
(94) 5.5 |
18 19 22 |
(20) 2.1 |
16 22 21 |
(20) 3.2 |
20 23 34 |
(26) 7.4 |
12 18 16 |
(15) 3.1 |
||||
- |
500 |
66 88 68 |
(74) 12.2 |
15 8 11 |
(11) 3.5 |
23 27 14 |
(21) 6.7 |
16 18 15 |
(16) 1.5 |
12 11 12 |
(12) 0.6 |
||||
- |
1500 |
70 88 91 |
(83) 11.4 |
15 14 18 |
(16) 2.1 |
18 16 29 |
(21) 7.0 |
15 14 14 |
(14) 0.6 |
10 16 14 |
(13) 3.1 |
||||
- |
5000 |
100 87 78 |
(88) 11.1 |
11 14 18 |
(14) 3.5 |
18 27 19 |
(21) 4.9 |
12 11 11 |
(11) 0.6 |
11 11 7 |
(10) 2.3 |
||||
Positive controls
S9-Mix
- |
Name Concentration (μg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||||||
3 |
5 |
2 |
0.2 |
80 |
|||||||||||
405 434 446 |
(428) 21.1 |
1740 1797 1525 |
(1687) 143.4 |
468 558 475 |
(500) 50.1 |
106 84 109 |
(100) 13.7 |
538 674 665 |
(626) 76.1 |
ENNG N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
# Standard deviationTable5 Test Results: Main Test– With Metabolic Activation
Test period |
From: 07 February 2010 |
To: 10 February 2010 |
||||||||||
With or without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||||||||
Base-pair substitution type |
Frameshift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA‑ |
TA98 |
TA1537 |
||||||||
+ |
0 |
77 87 109 |
(91) 16.4# |
16 11 18 |
(15) 3.6 |
27 20 35 |
(27) 7.5 |
16 16 27 |
(20) 6.4 |
9 20 14 |
(14) 5.5 |
|
+ |
50 |
77 87 109 |
(91) 16.4 |
10 14 23 |
(16) 6.7 |
19 19 31 |
(23) 6.9 |
30 19 18 |
(22) 6.7 |
12 12 20 |
(15) 4.6 |
|
+ |
150 |
85 91 103 |
(93) 9.2 |
16 9 9 |
(11) 4.0 |
24 23 23 |
(23) 0.6 |
24 24 24 |
(24) 0.0 |
18 7 26 |
(17) 9.5 |
|
+ |
500 |
82 85 97 |
(88) 7.9 |
13 14 5 |
(11) 4.9 |
19 14 27 |
(20) 6.6 |
18 24 23 |
(22) 3.2 |
11 15 13 |
(13) 2.0 |
|
+ |
1500 |
73 78 151 |
(101) 43.7 |
7 8 8 |
(8) 0.6 |
22 30 25 |
(26) 4.0 |
31 19 20 |
(23) 6.7 |
15 14 13 |
(14) 1.0 |
|
+ |
5000 |
120 59 85 |
(88) 30.6 |
9 5 8 |
(7) 2.1 |
16 23 16 |
(18) 4.0 |
33 25 16 |
(25) 8.5 |
11 9 10 |
(10) 1.0 |
|
Positive controls
S9-Mix
+ |
Name Concentration (μg/plate) No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
||||||
1 |
2 |
10 |
5 |
2 |
||||||||
1000 896 687 |
(861) 159.4 |
245 228 217 |
(230) 14.1 |
213 211 211 |
(212) 1.2 |
198 293 254 |
(248) 47.8 |
220 198 179 |
(199) 20.5 |
BP Benzo(a)pyrene
2AA 2-Aminoanthracene
# Standard deviation
PLEASE SEE ATTACHED IN OVERALL REMARKS, ATTACHMENTS 1) Figures1-4 Dose-Response Curves. 2) Pages 23 -30 (Appendix 1 Report of Results in Mutagenicity Test using Micro-organisms).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic under the conditions of this test.
This study is conducted according to an appropriate guideline and under the conditions of GLP, the study is therefore considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint. - Executive summary:
Introduction.
The method was designed to conform to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF. It also meets the requirements of the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Directive 2000/32/EC and the, EPA (TSCA) OPPTS harmonised guidelines.
Methods.
Salmonella typhimuriumstrains TA1535, TA1537, TA98 and TA100 andEscherichia colistrain WP2uvrA-were treated with the test material using both the Ames plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range for the range-finding test was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate. The experiment was repeated on a separate day (pre-incubation method) using the same dose range as the range-finding test, fresh cultures of the bacterial strains and fresh test material formulations.
Results.
The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method.
Conclusion.
The test material was considered to be non-mutagenic under the conditions of this test.
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