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EC number: 943-693-3 | CAS number: -
- 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
- Study period:
- Mar - Apr 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 Jul 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Landesamt für Umwelt Rheinland-Pfalz
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of diammonium (2R,3R)-2,3-dihydroxybutanedioate and diammonium bis[(2R,3R)-2,3-dioxidobutanedioato]diantimonate(2-)
- EC Number:
- 943-693-3
- IUPAC Name:
- Reaction mass of diammonium (2R,3R)-2,3-dihydroxybutanedioate and diammonium bis[(2R,3R)-2,3-dioxidobutanedioato]diantimonate(2-)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 170492F01
- Expiration date of the Batch: 22 Jun 2019
- Purity: 100.0 area-% (HPLC fingerprint)
- Content:
21.4 g/100 g Test item
23.5 g/100 g (NH4)2C4H4O6
30 g/100 g Tartrate
6.7 g/100 g Ammonium
9.1 g/100 g Antimony
53.5 g/100 g Water
- Physical state, appearance: liquid, colorless to yellowish, clear
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The stability of the test substance (aqueous solution) throughout the study period was guaranteed as indicated by the sponsor, therefore the stability of the test substance in the vehicle water was expected.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was weighed and topped up with the chosen vehicle to achieve the required concentration of the stock solution. The test substance was dissolved in water (= ultrapure water). To achieve a clear solution of the test substance in the vehicle, the test substance preparation was shaken thoroughly. The further concentrations were diluted from the stock solution according to the planned doses. All test substance formulations were prepared immediately before administration.
FORM AS APPLIED IN THE TEST (if different from that of starting material): aqueous solution
Method
- Target gene:
- his, trp
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and ß-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 0; 100; 500; 1000; 2750; 5500 and 11000 µg/plate (Experiment 1 and Experiment 2, respectively)
In agreement with the recommendations of current guidelines 5 mg/plate or 5 µL/plate were generally selected as maximum test dose at least in the 1st Experiment. However, this maximum dose was tested even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate or > 5 µL/plate might also be tested in repeat experiments for further clarification / substantiation.
In this study, due to the purity of the test substance 11.0 mg/plate was used as top dose in all experiments. - Vehicle / solvent:
- - Vehicle used: water
- Justification for choice of vehicle: Due to the good solubility of the test substance in water, water was used as vehicle.
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 2-aminoanthracene (with S9 mix; 2.5 µg/plate dissolved in DMSO for TA 1535, TA 100, TA 1537 & TA 98; 60 µg/plate dissolved in DMSO for E.coli WP2 uvrA)
- Remarks:
- further positive control substances: N-methyl-N'-nitro-N-nitrosoguanidine (without S9 mix; 5 µg/plate dissolved in DMSO for TA 1535 & TA 100), 4-nitro-o-phenylenediamine (without S9 mix; 10 µg/plate dissolved in DMSO for TA 98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min (PIT)
- Exposure duration: 48 - 72 h (SPT & PIT)
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants (factor ≤ 0.6), clearing or diminution of the background lawn (= reduced his- or trp- background growth) - Evaluation criteria:
- Mutagenicity:
Individual plate counts, the mean number of revertant colonies per plate and the standard deviations were given for all dose groups as well as for the positive and negative (vehicle) controls in all experiments. In general, six doses of the test substance were tested with a maximum of 5 mg/plate, and triplicate plating was used for all test groups at least in the 1st Experiment. Dose selection and evaluation as well as the number of plates used in repeat studies or further experiments were based on the findings in the 1st Experiment.
Toxicity:
Toxicity detected by a
- decrease in the number of revertants (factor ≤ 0.6)
- clearing or diminution of the background lawn (= reduced his- or trp- background growth)
was recorded for all test groups both with and without S9 mix in all experiments and indicated in the tables. Single values with a factor ≤ 0.6 were not detected as toxicity in low dose groups.
Solubility:
If precipitation of the test material was observed, it would be recorded and indicated in the tables. As long as precipitation did not interfere with the colony scoring, 5 mg/plate was generally selected and analyzed (in cases of nontoxic compounds) as the maximum dose at least in the 1st Experiment even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate might also be tested in repeat experiments for further clarification / substantiation. - Statistics:
- Acceptance criteria:
Generally, the experiment was considered valid if the following criteria were met
- The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies compatible with the range of the historical positive control data or above.
- Fresh bacterial culture containing approximately 10^9 cells per mL were used.
Assessment criteria:
The test substance was considered positive in this assay if the following criteria were met
- A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if
- The number of revertants for all tester strains were within the range of the historical negative control data under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- SPT with S9 mix from 5500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- PIT without S9 from 5500 µg/plate & with S9 from 11000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- SPT with S9 & PIT without S9 from 11000 µg/plate, respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found with and without S9 mix.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: see tables in any other information on results
- Negative (solvent/vehicle) historical control data: see tables in any other information on results
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: A weak bacteriotoxic effect (slight decrease in the number of his+ revertants) was observed in the standard plate test and in the preincubation assay depending on the strain and test conditions from about 5500 µg/plate onward.
DISCUSSION
According to the results of the present study, the test substance did not lead to a relevant increase in the number of revertant colonies without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay).
Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria.
In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
In addition, the positive control substances with and without S9 mix induced a significant increase in the number of revertant colonies compatible with the range of the historical positive control data.
Any other information on results incl. tables
Table 1: Decreased revertant numbers were observed at following concentrations [µg/plate]
Experiment |
S9 |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E.coli |
1st – SPT |
Without |
- |
- |
- |
- |
- |
With |
5500 – 11000 |
- |
- |
11000 |
- |
|
2nd – PIT |
Without |
- |
- |
5500 – 11000 |
11000 |
- |
With |
- |
- |
11000 |
- |
- |
Table 2: Standard plate test without metabolic activation
Strain |
Test group |
Dose [µg/plate] |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
Water Test item
MNNG |
- 100 500 1000 2750 5500 11000 5.0 |
8.0 8.7 9.0 9.3 9.7 7.3 9.7 5933.3 |
2.6 2.9 2.0 5.0 5.5 2.1 4.6 365.5 |
- 1.1 1.1 1.2 1.2 0.9 1.2 741.7 |
7, 6, 11 12, 7, 7 9, 11, 7 10, 14, 4 7, 16, 6 9, 5, 8 7, 7, 15 6024, 6245, 5531 |
TA 100 |
Water Test item
MNNG |
- 100 500 1000 2750 5500 11000 5.0 |
118.0 126.3 141.7 127.0 143.0 125.7 115.7 4294.0 |
27.5 4.2 28.0 5.6 12.3 10.0 11.8 133.0 |
- 1.1 1.2 1.1 1.2 1.1 1.0 36.4 |
119, 145, 90 125, 131, 123 148, 111, 166 128, 121, 132 148, 152, 129 122, 118, 137 122, 102, 123 4160, 4296, 4426 |
TA 1537 |
Water Test item
AAC |
- 100 500 1000 2750 5500 11000 100 |
9.0 7.3 7.3 9.7 4.7 6.3 6.3 849.0 |
1.0 2.5 2.1 1.5 2.1 1.2 1.5 136.0 |
- 0.8 0.8 1.1 0.5 0.7 0.7 94.3 |
9, 10, 8 5, 10, 7 5, 9, 8 8, 11, 10 4, 3, 7 7, 7, 5 6, 5, 8 692, 925, 930 |
TA 98 |
Water Test item
NOPD |
- 100 500 1000 2750 5500 11000 10 |
20.3 20.7 14.3 19.0 24.0 21.7 13.7 1132.0 |
2.1 8.3 2.5 4.6 3.0 8.1 3.2 77.1 |
- 1.0 0.7 0.9 1.2 1.1 0.7 55.7 |
22, 18, 21 14, 30, 18 12, 14, 17 15, 24, 18 21, 24, 27 16, 31, 18 16, 10, 15 1192, 1159, 1045 |
E.coli |
Water Test item
4-NQO |
- 100 500 1000 2750 5500 11000 5 |
33.0 31.7 28.3 26.0 28.3 21.7 30.3 766.3 |
7.2 5.8 6.1 3.6 3.5 2.5 7.0 18.2 |
- 1.0 0.9 0.8 0.9 0.7 0.9 23.2 |
35, 39, 25 35, 35, 25 35, 27, 23 30, 23, 25 28, 25, 32 24, 22, 19 31, 37, 23 763, 786, 750 |
Table 3: Standard plate test with metabolic activation
Strain |
Test group |
Dose [µg/plate] |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
13.7 10.3 11.0 8.7 11.0 7.7 6.7 210.7 |
1.5 2.5 1.0 1.5 1.0 1.5 3.1 5.7 |
- 0.8 0.8 0.6 0.8 0.6 0.5 15.4 |
15, 14, 12 13, 8, 10 12, 10, 11 9, 10, 7 10, 12, 11 9, 8, 6 10, 6, 4 206, 217, 209 |
TA 100 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
127.0 114.3 129.0 111.3 114.3 115.3 117.0 1565.0 |
5.3 16.1 15.1 5.1 12.5 8.3 17.4 117.3 |
- 0.9 1.0 0.9 0.9 0.9 0.9 12.3 |
129, 131, 121 121, 96, 126 143, 131, 113 110, 117, 107 123, 100, 120 122, 106, 118 129, 97, 125 1691, 1545, 1459 |
TA 1537 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
7.3 6.7 8.3 8.0 8.3 9.7 8.3 90.0 |
3.1 2.9 2.1 1.0 4.2 1.2 2.5 8.0 |
- 0.9 1.1 1.1 1.1 1.3 1.1 12.3 |
4, 10, 8 5, 10, 5 6, 10, 9 7, 8, 9 13, 5, 7 11, 9, 9 6, 11, 8 90, 98, 82 |
TA 98 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
30.7 29.7 26.3 27.3 28.3 22.0 18.0 1033.0 |
6.1 7.6 6.8 11.6 1.5 2.6 7.5 91.7 |
- 1.0 0.9 0.9 0.9 0.7 0.6 33.7 |
32, 36, 24 28, 38, 23 21, 34, 24 38, 29, 15 30, 28, 27 21, 20, 25 10, 19, 25 1102, 1068, 929 |
E.coli |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 60 |
24.0 28.3 27.0 27.0 30.0 30.0 26.7 92.7 |
1.7 4.0 1.0 5.3 1.0 5.6 4.0 1.5 |
- 1.2 1.1 1.1 1.3 1.3 1.1 3.9 |
25, 22, 25 32, 24, 29 26, 28, 27 25, 23, 33 31, 29, 30 35, 24, 31 29, 29, 22 93, 94, 91 |
Table 4: Preincubation test without metabolic activation
Strain |
Test group |
Dose [µg/plate] |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
Water Test item
MNNG |
- 100 500 1000 2750 5500 11000 5.0 |
9.7 8.3 7.0 8.7 12.0 8.0 8.0 2417.3 |
4.5 2.5 2.0 3.1 3.6 2.6 1.7 309.5 |
- 0.9 0.7 0.9 1.2 0.8 0.8 250.1 |
5, 10, 14 11, 6, 8 5, 7, 9 8, 6, 12 11, 16, 9 7, 6, 11 10, 7, 7 2493, 2077, 2682 |
TA 100 |
Water Test item
MNNG |
- 100 500 1000 2750 5500 11000 5.0 |
109.3 102.0 112.7 104.3 102.3 102.0 116.3 3483.3 |
10.2 15.7 4.7 11.2 14.2 16.8 7.8 252.7 |
- 0.9 1.0 1.0 0.9 0.9 1.1 31.9 |
105, 102, 121 109, 113, 84 111, 109, 118 114, 92, 107 115, 87, 105 83, 115, 108 110, 125, 114 3772, 3376, 3302 |
TA 1537 |
Water Test item
AAC |
- 100 500 1000 2750 5500 11000 100 |
9.0 5.3 8.3 11.7 10.0 5.3 5.3 807.7 |
2.0 2.1 2.5 2.5 3.6 4.0 0.6 123.6 |
- 0.6 0.9 1.3 1.1 0.6 0.6 89.7 |
7, 9, 11 3, 7, 6 11, 6, 8 9, 14, 12 7, 14, 9 10, 3, 3 6, 5, 5 950, 727, 746 |
TA 98 |
Water Test item
NOPD |
- 100 500 1000 2750 5500 11000 10 |
21.3 18.3 19.3 16.7 19.0 17.7 12.7 1234.0 |
6.5 5.0 6.4 4.6 1.7 7.2 3.1 113.2 |
- 0.9 0.9 0.8 0.9 0.8 0.6 57.8 |
21, 15, 28 13, 19, 23 23, 23, 12 14, 22, 14 18, 21, 18 26, 14, 13 12, 16, 10 1287, 1311, 1104 |
E.coli |
Water Test item
4-NQO |
- 100 500 1000 2750 5500 11000 5 |
30.0 35.3 32.7 27.3 24.7 25.7 26.3 526.3 |
7.0 3.2 5.8 4.6 5.0 1.5 2.3 73.0 |
- 1.2 1.1 0.9 0.8 0.9 0.9 17.5 |
30, 23, 37 39, 33, 34 26, 36, 36 22, 30, 30 24, 20, 30 27, 24, 26 25, 29, 25 569, 568, 442 |
Table 5: Preincubation test with metabolic activation
Strain |
Test group |
Dose [µg/plate] |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
7.0 10.0 5.7 9.7 6.7 8.0 6.7 206.0 |
2.0 4.0 1.5 2.3 2.1 1.0 2.5 17.8 |
- 1.4 0.8 1.4 1.0 1.1 1.0 29.4 |
5, 7, 9 6, 14, 10 7, 4, 6 11, 11, 7 5, 9, 6 9, 7, 8 9, 7, 4 200, 192, 226 |
TA 100 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
111.3 118.0 103.0 104.3 126.3 123.0 109.3 2141.0 |
6.1 18.0 12.5 20.5 11.5 15.5 5.5 37.2 |
- 1.1 0.9 0.9 1.1 1.1 1.0 19.2 |
110, 118, 106 123, 133, 98 115, 90, 104 92, 93, 128 133, 113, 133 124, 138, 107 104, 115, 109 2170, 2099, 2154 |
TA 1537 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
9.0 9.0 9.7 7.0 11.3 7.3 5.7 127.3 |
3.5 3.6 0.6 3.5 0.6 5.0 1.5 14.2 |
- 1.0 1.1 0.8 1.3 0.8 0.6 14.1 |
13, 7, 7 8, 13, 6 9, 10, 10 9, 3, 9 11, 11, 12 2, 8, 12 6, 7, 4 111, 137, 134 |
TA 98 |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 2.5 |
24.7 27.0 23.7 21.7 20.3 22.0 19.0 1494.3 |
2.5 4.4 5.9 7.5 3.1 9.2 1.7 318.9 |
- 1.1 1.0 0.9 0.8 0.9 0.8 60.6 |
27, 22, 25 32, 25, 24 28, 26, 17 22, 14, 29 23, 21, 17 12, 30, 24 18, 18, 21 1234, 1399, 1850 |
E.coli |
Water Test item
2-AA |
- 100 500 1000 2750 5500 11000 60 |
30.3 30.7 29.0 23.0 28.7 30.0 23.0 127.3 |
7.1 1.5 6.6 6.2 4.0 3.0 4.6 16.1 |
- 1.0 1.0 0.8 0.9 1.0 0.8 4.2 |
29, 24, 38 29, 31, 32 28, 36, 23 16, 28, 25 33, 28, 25 33, 27, 30 28, 22, 19 134, 139, 109 |
Table 6: Historical negative control data
Strain |
S9 Mix |
Vehicle |
No. of Plates |
No. of Values |
Min |
Max |
Mean |
SD |
TA 1535 |
Without With |
(All) (All) |
414 414 |
152 152 |
7 6 |
16 18 |
10 10 |
2.0 2.0 |
TA 100 |
Without With |
(All) (All) |
426 417 |
152 153 |
71 70 |
132 147 |
100 107 |
11.4 13.7 |
TA 1537 |
Without With |
(All) (All) |
411 411 |
152 152 |
5 5 |
13 16 |
8 9 |
1.7 2.1 |
TA 98 |
Without With |
(All) (All) |
420 413 |
152 152 |
14 12 |
34 38 |
21 28 |
3.3 4.5 |
E.coli |
Without With |
(All) (All) |
396 399 |
152 152 |
15 17 |
34 36 |
24 25 |
3.9 4.4 |
Table 7: Historical positive control data
Strain |
S9 Mix |
Positive Control |
No. of Plates |
No. of Values |
Min |
Max |
Mean |
SD |
TA 1535 |
Without With |
MNNG 2-AA |
312 312 |
110 110 |
1541 105 |
6171 520 |
3967 197 |
1253.9 56.3 |
TA 100 |
Without With |
MNNG 2-AA |
315 309 |
110 111 |
1126 272 |
5557 3021 |
3298 1748 |
1109.6 587.2 |
TA 1537 |
Without With |
AAC 2-AA |
309 312 |
110 110 |
253 50 |
2190 399 |
1044 141 |
404.3 50.3 |
TA 98 |
Without With |
NOPD 2-AA |
309 315 |
110 110 |
324 493 |
1746 3096 |
863 1524 |
206.8 529.1 |
E.coli |
Without With |
4-NQO 2-AA |
306 306 |
110 110 |
164 61 |
1721 537 |
860 133 |
431.9 61.8 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions chosen here, it is concluded that the test substance is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay.
Strains: TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA
Dose Range: 100 µg - 11000 µg/plate (SPT), 100 µg - 11000 µg/plate (PIT)
Test Conditions: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).
Solubility: No precipitation of the test substance was found with and without S9 mix.
Toxicity: A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions from about 5500 µg/plate onward.
Mutagenicity: A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.
Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium / Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
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