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EC number: - | 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
- Biodegradation
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- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 16 May - 05 June 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of dipotassium 2-(3,4-dimethyl-1H-pyrazol-1-yl) succinate and dipotassium 2-(4,5-dimethy-1H-pyrazol-1-yl) succinate
- Molecular formula:
- C9H10K2N2O4
- IUPAC Name:
- Reaction mass of dipotassium 2-(3,4-dimethyl-1H-pyrazol-1-yl) succinate and dipotassium 2-(4,5-dimethy-1H-pyrazol-1-yl) succinate
1
Method
- Target gene:
- his operon (for S. typhimurium strains) and trp operon (for E. coli strain)
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with phenobarbital/beta-naphthoflavone
- Test concentrations with justification for top dose:
- First experiment: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation (tested up to the recommended maximum concentration)
Second experiment: 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation (tested up to the recommended maximum concentration) - Vehicle / solvent:
- - Vehicle used: deionized water
- Justification for choice of vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, (4-NOPD), 2-Aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation (first experiment); preincubation (second experiment)
DURATION
- Preincubation period: 1 h
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: bacterial growth inhibition, reduction in the number of spontaneous revertants (below a factor of 0.5) or a clearing of the bacterial background lawn.
- Rationale for test conditions:
- In the pre-experiment the concentration range of the test item was 3 – 5000 µg/plate. The pre-experiment is reported as experiment I. Since no relevant toxic effects were observed
- Evaluation criteria:
- - A test item is considered as a mutagen if a biologically relevant increase in the number of revertants of twofold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) the spontaneous mutation rate of the corresponding solvent control is observed.
- A dose dependent increase is considered biologically relevant if the threshold is reached or exceeded at one or more concentrations.
- An increase of revertant colonies equal or above the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant - Statistics:
- Mean numbers of the revertant colonies of each concentration of each test system was calculated and compared to that of the solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- 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
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- 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
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
No relevant effect on bacterial growth was observed in any strain at any test concentration.
Any other information on results incl. tables
Table 1: Summary Results Experiment I (plate incorporation)
|
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||||
|
|
|
|
|
|
|
|
||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
||
|
|
|
|
|
|
|
|
||
Without Activation |
Deionised water |
|
16 ± 4 |
10 ± 3 |
28 ± 2 |
106 ± 9 |
50 ± 3 |
||
Untreated |
|
11 ± 4 |
11 ± 1 |
33 ± 6 |
100 ± 8 |
55 ± 7 |
|||
Test item |
3 µg |
13 ± 4 |
12 ± 2 |
29 ± 12 |
94 ± 13 |
47 ± 18 |
|||
|
10 µg |
16 ± 2 |
11 ± 3 |
34 ± 10 |
104 ± 19 |
49 ± 10 |
|||
|
33 µg |
16 ± 4 |
10 ± 1 |
34 ± 8 |
93 ± 16 |
52 ± 3 |
|||
|
100 µg |
15 ± 5 |
10 ± 3 |
30 ± 3 |
99 ± 8 |
52 ± 15 |
|||
|
333 µg |
12 ± 2 |
6 ± 2 |
34 ± 5 |
92 ± 11 |
58 ± 10 |
|||
|
1000 µg |
11 ± 1 |
12 ± 4 |
32 ± 3 |
98 ± 12 |
53 ± 10 |
|||
|
2500 µg |
10 ± 1 |
11 ± 2 |
34 ± 11 |
93 ± 14 |
49 ± 9 |
|||
|
5000 µg |
16 ± 3 |
11 ± 1 |
37 ± 10 |
88 ± 3 |
57 ± 17 |
|||
NaN3 |
10 µg |
1119 ± 35 |
|
|
1542 ± 75 |
|
|||
4-NOPD |
10 µg |
|
|
405 ± 30 |
|
|
|||
4-NOPD |
50 µg |
|
73 ± 10 |
|
|
|
|||
MMS |
2.0 µL |
|
|
|
|
963 ± 28 |
|||
|
|
|
|
|
|
|
|
||
With Activation |
Deionised water |
|
11 ± 5 |
16 ± 4 |
35 ± 6 |
114 ± 12 |
55 ± 10 |
||
Untreated |
|
16 ± 4 |
16 ± 1 |
40 ± 12 |
116 ± 14 |
62 ± 1 |
|||
Test item |
3 µg |
9 ± 5 |
15 ± 4 |
45 ± 6 |
98 ± 13 |
51 ± 6 |
|||
|
10 µg |
11 ± 3 |
17 ± 7 |
36 ± 8 |
118 ± 16 |
54 ± 6 |
|||
|
33 µg |
11 ± 4 |
16 ± 4 |
40 ± 12 |
115 ± 10 |
56 ± 11 |
|||
|
100 µg |
10 ± 5 |
16 ± 1 |
40 ± 6 |
110 ± 6 |
56 ± 16 |
|||
|
333 µg |
13 ± 4 |
15 ± 2 |
43 ± 9 |
94 ± 12 |
58 ± 8 |
|||
|
1000 µg |
9 ± 3 |
20 ± 6 |
38 ± 3 |
96 ± 14 |
59 ± 7 |
|||
|
2500 µg |
10 ± 1 |
14 ± 6 |
41 ± 15 |
105 ± 26 |
61 ± 4 |
|||
|
5000 µg |
10 ± 4 |
18 ± 4 |
40 ± 7 |
85 ± 5 |
53 ± 5 |
|||
2-AA |
2.5 µg |
325 ± 24 |
417 ± 10 |
3168 ± 188 |
2727 ± 207 |
|
|||
2-AA |
10.0 µg |
|
|
|
|
306 ± 12 |
|||
|
|
|
|
|
|
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
|
|||||||
Table 2: Summary Results Experiment II (pre incubation)
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||||
|
|
|
|
|
|
|
|
||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
||
|
|
|
|
|
|
|
|
||
Without Activation |
Deionionised water |
|
17 ± 6 |
15 ± 6 |
30 ± 4 |
102 ± 16 |
52 ± 9 |
||
Untreated |
|
15 ± 3 |
18 ± 1 |
36 ± 3 |
113 ± 16 |
55 ± 4 |
|||
Test item |
33 µg |
13 ± 3 |
14 ± 4 |
34 ± 9 |
122 ± 14 |
60 ± 7 |
|||
|
100 µg |
15 ± 4 |
16 ± 7 |
41 ± 2 |
108 ± 11 |
56 ± 10 |
|||
|
333 µg |
15 ± 0 |
15 ± 6 |
32 ± 8 |
106 ± 17 |
64 ± 5 |
|||
|
1000 µg |
14 ± 6 |
16 ± 3 |
31 ± 10 |
113 ± 9 |
61 ± 4 |
|||
|
2500 µg |
13 ± 4 |
17 ± 3 |
33 ± 2 |
116 ± 5 |
58 ± 9 |
|||
|
5000 µg |
16 ± 6 |
13 ± 3 |
33 ± 9 |
103 ± 11 |
56 ± 7 |
|||
NaN3 |
10 µg |
1290 ± 5 |
|
|
1603 ± 111 |
|
|||
4-NOPD |
10 µg |
|
|
447 ± 10 |
|
|
|||
4-NOPD |
50 µg |
|
86 ± 4 |
|
|
|
|||
MMS |
2.0 µL |
|
|
|
|
760 ± 31 |
|||
|
|
|
|
|
|
|
|
||
With Activation |
Deionionised water |
|
16 ± 4 |
17 ± 6 |
44 ± 8 |
110 ± 9 |
61 ± 4 |
||
Untreated |
|
10 ± 2 |
15 ± 2 |
46 ± 6 |
112 ± 3 |
63 ± 9 |
|||
Test item |
33 µg |
13 ± 1 |
16 ± 4 |
41 ± 14 |
108 ± 2 |
64 ± 17 |
|||
|
100 µg |
15 ± 7 |
16 ± 5 |
47 ± 6 |
103 ± 6 |
68 ± 9 |
|||
|
333 µg |
15 ± 6 |
15 ± 4 |
44 ± 5 |
110 ± 9 |
60 ± 3 |
|||
|
1000 µg |
12 ± 3 |
19 ± 4 |
48 ± 4 |
102 ± 1 |
61 ± 1 |
|||
|
2500 µg |
14 ± 2 |
16 ± 6 |
45 ± 3 |
95 ± 11 |
54 ± 6 |
|||
|
5000 µg |
13 ± 4 |
16 ± 4 |
47 ± 8 |
110 ± 3 |
59 ± 7 |
|||
2-AA |
2.5 µg |
308 ± 13 |
265 ± 6 |
2865 ± 116 |
3148 ± 186 |
|
|||
2-AA |
10.0 µg |
|
|
|
|
366 ± 1 |
|||
|
|
|
|
|
|
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
|
Table 3: Individual Results of Experiment I (Without metabolic activation)
Strain |
Compound |
Dose level per plate |
Mean revertants per plate |
Standard Deviation |
Ratio treated / solvent |
Individual revertant colony counts |
||
TA 1535 |
Test item |
3 µg |
13.3 |
3.8 |
0.8 |
15, 16, 9 |
||
|
|
10 µg |
15.7 |
1.5 |
1.0 |
16, 14, 17 |
||
|
|
33 µg |
15.7 |
4.2 |
1.0 |
19, 17, 11 |
||
|
|
100 µg |
14.7 |
5.1 |
0.9 |
9, 19, 16 |
||
|
|
333 µg |
12.0 |
2.0 |
0.7 |
12, 14, 10 |
||
|
|
1000 µg |
10.7 |
0.6 |
0.7 |
11, 11, 10 |
||
|
|
2500 µg |
10.3 |
0.6 |
0.6 |
10, 11, 10 |
||
|
|
5000 µg |
16.3 |
3.2 |
1.0 |
15, 20, 14 |
||
|
Deionised water |
|
16.3 |
4.0 |
|
14, 21, 14 |
||
|
Untreated Control |
|
11.0 |
4.0 |
|
7, 15, 11 |
||
|
|
|
|
|
|
|
||
TA 1537 |
Test item |
3 µg |
12.3 |
1.5 |
1.3 |
14, 12, 11 |
||
|
|
10 µg |
11.0 |
2.6 |
1.1 |
10, 9, 14 |
||
|
|
33 µg |
9.7 |
1.2 |
1.0 |
9, 11, 9 |
||
|
|
100 µg |
9.7 |
2.5 |
1.0 |
12, 7, 10 |
||
|
|
333 µg |
6.3 |
2.3 |
0.7 |
5, 9, 5 |
||
|
|
1000 µg |
12.0 |
4.4 |
1.2 |
7, 14, 15 |
||
|
|
2500 µg |
11.3 |
2.3 |
1.2 |
10, 10, 14 |
||
|
|
5000 µg |
10.7 |
0.6 |
1.1 |
11, 11, 10 |
||
|
Deionised water |
|
9.7 |
2.5 |
|
7, 12, 10 |
||
|
Untreated Control |
|
10.7 |
1.2 |
|
10, 12, 10 |
||
|
|
|
|
|
|
|
||
TA 98 |
Test item |
3 µg |
29.0 |
12.1 |
1.0 |
22, 22, 43 |
||
|
|
10 µg |
34.0 |
10.1 |
1.2 |
32, 25, 45 |
||
|
|
33 µg |
34.3 |
8.3 |
1.2 |
37, 25, 41 |
||
|
|
100 µg |
30.3 |
3.1 |
1.1 |
31, 27, 33 |
||
|
|
333 µg |
34.3 |
5.1 |
1.2 |
30, 33, 40 |
||
|
|
1000 µg |
31.7 |
2.9 |
1.1 |
30, 35, 30 |
||
|
|
2500 µg |
34.3 |
10.7 |
1.2 |
32, 46, 25 |
||
|
|
5000 µg |
37.3 |
10.0 |
1.3 |
26, 41, 45 |
||
|
Deionised water |
|
28.0 |
2.0 |
|
26, 30, 28 |
||
|
Untreated Control |
|
33.0 |
6.1 |
|
36, 26, 37 |
||
|
|
|
|
|
|
|
||
TA 100 |
Test item |
3 µg |
93.7 |
12.9 |
0.9 |
99, 79, 103 |
||
|
|
10 µg |
104.0 |
19.2 |
1.0 |
113, 117, 82 |
||
|
|
33 µg |
92.7 |
15.6 |
0.9 |
91, 109, 78 |
||
|
|
100 µg |
99.3 |
7.6 |
0.9 |
96, 108, 94 |
||
|
|
333 µg |
91.7 |
10.6 |
0.9 |
82, 103, 90 |
||
|
|
1000 µg |
98.0 |
12.2 |
0.9 |
106, 84, 104 |
||
|
|
2500 µg |
92.7 |
14.2 |
0.9 |
108, 80, 90 |
||
|
|
5000 µg |
87.7 |
2.5 |
0.8 |
88, 85, 90 |
||
|
Deionised water |
|
105.7 |
9.0 |
|
101, 116, 100 |
||
|
Untreated Control |
|
100.3 |
7.8 |
|
94, 98, 109 |
||
|
|
|
|
|
|
|
||
WP2 |
Test item |
3 µg |
47.0 |
18.2 |
0.9 |
68, 37, 36 |
||
uvrA |
|
10 µg |
49.3 |
10.0 |
1.0 |
38, 53, 57 |
||
|
|
33 µg |
52.0 |
2.6 |
1.0 |
49, 53, 54 |
||
|
|
100 µg |
52.0 |
15.1 |
1.0 |
69, 47, 40 |
||
|
|
333 µg |
57.7 |
10.1 |
1.2 |
47, 59, 67 |
||
|
|
1000 µg |
53.3 |
10.0 |
1.1 |
57, 42, 61 |
||
|
|
2500 µg |
49.0 |
8.5 |
1.0 |
41, 58, 48 |
||
|
|
5000 µg |
56.7 |
16.8 |
1.1 |
53, 75, 42 |
||
|
Deionised water |
|
50.0 |
2.6 |
|
47, 52, 51 |
||
|
Untreated Control |
|
54.7 |
7.0 |
|
48, 54, 62 |
||
|
|
|
|
|
|
|
||
TA 1535 |
NaN3 |
10 µg |
1119.3 |
35.2 |
68.5 |
1152, 1124, 1082 |
||
TA 1537 |
4-NOPD |
50 µg |
73.0 |
10.1 |
7.6 |
82, 62, 75 |
||
TA 98 |
4-NOPD |
10 µg |
405.3 |
29.8 |
14.5 |
425, 420, 371 |
||
TA 100 |
NaN3 |
10 µg |
1542.0 |
75.4 |
14.6 |
1629, 1500, 1497 |
||
WP2 uvrA |
MMS |
2.0 µL |
962.7 |
28.2 |
19.3 |
985, 972, 931 |
||
NaN3 4-NOPD MMS |
sodium azide 4-nitro-o-phenylene-diamine methyl methane sulfonate |
|||||||
Table 4: Individual Results of Experiment I (With metabolic activation)
Strain |
Compound |
Dose level per plate |
Mean revertants per plate |
Standard Deviation |
Ratio treated / solvent |
Individual revertant colony counts |
||||
TA 1535 |
Test item |
3 µg |
9.3 |
4.9 |
0.8 |
15, 6, 7 |
||||
|
|
10 µg |
11.3 |
2.5 |
1.0 |
11, 14, 9 |
||||
|
|
33 µg |
11.0 |
3.6 |
1.0 |
7, 14, 12 |
||||
|
|
100 µg |
9.7 |
4.6 |
0.9 |
7, 15, 7 |
||||
|
|
333 µg |
13.0 |
3.6 |
1.1 |
17, 10, 12 |
||||
|
|
1000 µg |
9.0 |
3.0 |
0.8 |
12, 6, 9 |
||||
|
|
2500 µg |
9.7 |
0.6 |
0.9 |
9, 10, 10 |
||||
|
|
5000 µg |
10.0 |
4.0 |
0.9 |
10, 14, 6 |
||||
|
Deionised water |
|
11.3 |
5.1 |
|
17, 10, 7 |
||||
|
Untreated Control |
|
15.7 |
4.2 |
|
17, 11, 19 |
||||
|
|
|
|
|
|
|
||||
TA 1537 |
Test item |
3 µg |
15.3 |
4.0 |
1.0 |
19, 16, 11 |
||||
|
|
10 µg |
17.0 |
7.0 |
1.1 |
9, 22, 20 |
||||
|
|
33 µg |
16.3 |
4.0 |
1.0 |
14, 21, 14 |
||||
|
|
100 µg |
16.0 |
1.0 |
1.0 |
17, 16, 15 |
||||
|
|
333 µg |
15.3 |
1.5 |
1.0 |
15, 14, 17 |
||||
|
|
1000 µg |
19.7 |
5.5 |
1.3 |
14, 25, 20 |
||||
|
|
2500 µg |
13.7 |
6.4 |
0.9 |
10, 10, 21 |
||||
|
|
5000 µg |
18.0 |
3.6 |
1.1 |
14, 19, 21 |
||||
|
Deionised water |
|
15.7 |
4.0 |
|
12, 20, 15 |
||||
|
Untreated Control |
|
15.7 |
1.2 |
|
17, 15, 15 |
||||
|
|
|
|
|
|
|
||||
TA 98 |
Test item |
3 µg |
45.0 |
6.1 |
1.3 |
41, 42, 52 |
||||
|
|
10 µg |
36.3 |
7.6 |
1.0 |
43, 38, 28 |
||||
|
|
33 µg |
39.7 |
12.4 |
1.1 |
32, 33, 54 |
||||
|
|
100 µg |
40.3 |
6.4 |
1.1 |
43, 45, 33 |
||||
|
|
333 µg |
42.7 |
9.3 |
1.2 |
47, 49, 32 |
||||
|
|
1000 µg |
37.7 |
2.5 |
1.1 |
38, 35, 40 |
||||
|
|
2500 µg |
41.0 |
14.7 |
1.2 |
58, 32, 33 |
||||
|
|
5000 µg |
40.0 |
7.0 |
1.1 |
47, 40, 33 |
||||
|
Deionised water |
|
35.3 |
5.9 |
|
31, 33, 42 |
||||
|
Untreated Control |
|
40.0 |
11.5 |
|
51, 28, 41 |
||||
|
|
|
|
|
|
|
||||
TA 100 |
Test item |
3 µg |
97.7 |
13.1 |
0.9 |
84, 99, 110 |
||||
|
|
10 µg |
117.7 |
15.6 |
1.0 |
134, 103, 116 |
||||
|
|
33 µg |
115.0 |
9.5 |
1.0 |
125, 106, 114 |
||||
|
|
100 µg |
109.7 |
5.5 |
1.0 |
110, 115, 104 |
||||
|
|
333 µg |
94.3 |
12.1 |
0.8 |
90, 85, 108 |
||||
|
|
1000 µg |
96.0 |
14.4 |
0.8 |
100, 108, 80 |
||||
|
|
2500 µg |
105.0 |
26.0 |
0.9 |
75, 121, 119 |
||||
|
|
5000 µg |
85.3 |
4.9 |
0.7 |
82, 91, 83 |
||||
|
Deionised water |
|
114.3 |
11.6 |
|
122, 120, 101 |
||||
|
Untreated Control |
|
116.0 |
13.7 |
|
113, 104, 131 |
||||
|
|
|
|
|
|
|
||||
WP2 |
Test item |
3 µg |
50.7 |
5.5 |
0.9 |
56, 51, 45 |
||||
uvrA |
|
10 µg |
53.7 |
5.9 |
1.0 |
56, 47, 58 |
||||
|
|
33 µg |
56.0 |
11.4 |
1.0 |
64, 61, 43 |
||||
|
|
100 µg |
55.7 |
15.9 |
1.0 |
74, 46, 47 |
||||
|
|
333 µg |
58.0 |
7.5 |
1.1 |
51, 66, 57 |
||||
|
|
1000 µg |
58.7 |
6.7 |
1.1 |
53, 66, 57 |
||||
|
|
2500 µg |
60.7 |
3.5 |
1.1 |
64, 57, 61 |
||||
|
|
5000 µg |
53.0 |
5.0 |
1.0 |
48, 58, 53 |
||||
|
Deionised water |
|
54.7 |
9.8 |
|
49, 66, 49 |
||||
|
Untreated Control |
|
62.3 |
0.6 |
|
63, 62, 62 |
||||
|
|
|
|
|
|
|
||||
TA 1535 |
2-AA |
2.5 µg |
325.0 |
23.6 |
28.7 |
345, 299, 331 |
||||
TA 1537 |
2-AA |
2.5 µg |
416.7 |
9.7 |
26.6 |
406, 419, 425 |
||||
TA 98 |
2-AA |
2.5 µg |
3168.3 |
188.3 |
89.7 |
3143, 2994, 3368 |
||||
TA 100 |
2-AA |
2.5 µg |
2726.7 |
207.1 |
23.8 |
2910, 2768, 2502 |
||||
WP2 uvrA |
2-AA |
10.0 µg |
306.3 |
11.6 |
5.6 |
312, 293, 314 |
||||
2-AA |
2-aminoanthracene |
|
||||||||
Table 5: Individual Results of Experiment II (Without metabolic activation)
Strain |
Compound |
Dose level per plate |
Mean revertants per plate |
Standard Deviation |
Ratio treated / solvent |
Individual revertant colony counts |
||
TA 1535 |
Test item |
33 µg |
12.7 |
3.2 |
0.7 |
14, 9, 15 |
||
|
|
100 µg |
15.0 |
4.0 |
0.9 |
11, 15, 19 |
||
|
|
333 µg |
15.0 |
0.0 |
0.9 |
15, 15, 15 |
||
|
|
1000 µg |
13.7 |
5.5 |
0.8 |
10, 20, 11 |
||
|
|
2500 µg |
13.0 |
3.6 |
0.8 |
12, 17, 10 |
||
|
|
5000 µg |
15.7 |
6.0 |
0.9 |
15, 22, 10 |
||
|
Deionised water |
|
17.0 |
6.2 |
|
22, 19, 10 |
||
|
Untreated Control |
|
14.7 |
2.5 |
|
12, 15, 17 |
||
|
|
|
|
|
|
|
||
TA 1537 |
Test item |
33 µg |
14.0 |
3.6 |
1.0 |
10, 15, 17 |
||
|
|
100 µg |
16.0 |
6.6 |
1.1 |
9, 22, 17 |
||
|
|
333 µg |
14.7 |
5.5 |
1.0 |
9, 15, 20 |
||
|
|
1000 µg |
16.3 |
2.5 |
1.1 |
19, 16, 14 |
||
|
|
2500 µg |
17.3 |
2.9 |
1.2 |
14, 19, 19 |
||
|
|
5000 µg |
12.7 |
3.2 |
0.9 |
9, 15, 14 |
||
|
Deionised water |
|
14.7 |
6.0 |
|
14, 9, 21 |
||
|
Untreated Control |
|
17.7 |
1.2 |
|
17, 19, 17 |
||
|
|
|
|
|
|
|
||
TA 98 |
Test item |
33 µg |
34.0 |
8.5 |
1.1 |
25, 42, 35 |
||
|
|
100 µg |
41.3 |
1.5 |
1.4 |
40, 43, 41 |
||
|
|
333 µg |
31.7 |
8.1 |
1.0 |
41, 26, 28 |
||
|
|
1000 µg |
31.3 |
9.8 |
1.0 |
20, 37, 37 |
||
|
|
2500 µg |
33.3 |
1.5 |
1.1 |
33, 32, 35 |
||
|
|
5000 µg |
33.3 |
9.3 |
1.1 |
36, 41, 23 |
||
|
Deionised water |
|
30.3 |
4.0 |
|
28, 35, 28 |
||
|
Untreated Control |
|
35.7 |
2.5 |
|
36, 33, 38 |
||
|
|
|
|
|
|
|
||
TA 100 |
Test item |
33 µg |
122.0 |
13.9 |
1.2 |
115, 138, 113 |
||
|
|
100 µg |
107.7 |
11.0 |
1.1 |
114, 114, 95 |
||
|
|
333 µg |
105.7 |
16.7 |
1.0 |
119, 87, 111 |
||
|
|
1000 µg |
113.3 |
8.6 |
1.1 |
104, 121, 115 |
||
|
|
2500 µg |
116.3 |
5.0 |
1.1 |
121, 111, 117 |
||
|
|
5000 µg |
103.3 |
11.2 |
1.0 |
113, 106, 91 |
||
|
Deionised water |
|
102.0 |
16.1 |
|
85, 104, 117 |
||
|
Untreated Control |
|
113.3 |
16.2 |
|
132, 104, 104 |
||
|
|
|
|
|
|
|
||
WP2 |
Test item |
33 µg |
60.3 |
7.0 |
1.2 |
53, 67, 61 |
||
uvrA |
|
100 µg |
56.0 |
10.0 |
1.1 |
66, 46, 56 |
||
|
|
333 µg |
64.0 |
5.0 |
1.2 |
59, 64, 69 |
||
|
|
1000 µg |
60.7 |
4.2 |
1.2 |
64, 56, 62 |
||
|
|
2500 µg |
57.7 |
9.3 |
1.1 |
62, 64, 47 |
||
|
|
5000 µg |
55.7 |
6.5 |
1.1 |
62, 56, 49 |
||
|
Deionised water |
|
51.7 |
9.1 |
|
45, 48, 62 |
||
|
Untreated Control |
|
54.7 |
4.0 |
|
59, 54, 51 |
||
|
|
|
|
|
|
|
||
TA 1535 |
NaN3 |
10 µg |
1290.0 |
5.2 |
75.9 |
1287, 1296, 1287 |
||
TA 1537 |
4-NOPD |
50 µg |
86.0 |
3.6 |
5.9 |
87, 89, 82 |
||
TA 98 |
4-NOPD |
10 µg |
447.3 |
10.2 |
14.7 |
443, 440, 459 |
||
TA 100 |
NaN3 |
10 µg |
1603.0 |
110.7 |
15.7 |
1710, 1489, 1610 |
||
WP2 uvrA |
MMS |
2.0 µL |
760.3 |
30.7 |
14.7 |
785, 726, 770 |
||
NaN3 4-NOPD MMS |
sodium azide 4-nitro-o-phenylene-diamine methyl methane sulfonate |
|||||||
Table 6: Individual Results of Experiment II (With metabolic activation)
Strain |
Compound |
Dose level per plate |
Mean revertants per plate |
Standard Deviation |
Ratio treated / solvent |
Individual revertant colony counts |
|||
TA 1535 |
Test item |
33 µg |
12.7 |
1.2 |
0.8 |
12, 14, 12 |
|||
|
|
100 µg |
15.3 |
6.5 |
1.0 |
9, 15, 22 |
|||
|
|
333 µg |
15.3 |
5.5 |
1.0 |
10, 15, 21 |
|||
|
|
1000 µg |
11.7 |
3.1 |
0.7 |
9, 15, 11 |
|||
|
|
2500 µg |
14.0 |
2.0 |
0.9 |
16, 12, 14 |
|||
|
|
5000 µg |
13.0 |
3.6 |
0.8 |
17, 10, 12 |
|||
|
Deionised water |
|
16.0 |
3.6 |
|
19, 12, 17 |
|||
|
Untreated Control |
|
10.3 |
1.5 |
|
9, 12, 10 |
|||
|
|
|
|
|
|
|
|||
TA 1537 |
Test item |
33 µg |
15.7 |
4.0 |
0.9 |
20, 12, 15 |
|||
|
|
100 µg |
16.3 |
4.5 |
1.0 |
16, 21, 12 |
|||
|
|
333 µg |
14.7 |
4.0 |
0.9 |
11, 19, 14 |
|||
|
|
1000 µg |
19.0 |
3.6 |
1.1 |
20, 15, 22 |
|||
|
|
2500 µg |
15.7 |
6.0 |
0.9 |
22, 10, 15 |
|||
|
|
5000 µg |
15.7 |
4.2 |
0.9 |
11, 19, 17 |
|||
|
Deionised water |
|
17.0 |
6.0 |
|
17, 23, 11 |
|||
|
Untreated Control |
|
15.3 |
1.5 |
|
15, 17, 14 |
|||
|
|
|
|
|
|
|
|||
TA 98 |
Test item |
33 µg |
41.3 |
13.6 |
0.9 |
43, 27, 54 |
|||
|
|
100 µg |
47.3 |
6.0 |
1.1 |
48, 53, 41 |
|||
|
|
333 µg |
43.7 |
4.9 |
1.0 |
47, 38, 46 |
|||
|
|
1000 µg |
48.3 |
4.2 |
1.1 |
45, 47, 53 |
|||
|
|
2500 µg |
45.3 |
2.5 |
1.0 |
48, 45, 43 |
|||
|
|
5000 µg |
46.7 |
7.8 |
1.1 |
38, 53, 49 |
|||
|
Deionised water |
|
43.7 |
8.1 |
|
51, 45, 35 |
|||
|
Untreated Control |
|
46.0 |
6.1 |
|
42, 53, 43 |
|||
|
|
|
|
|
|
|
|||
TA 100 |
Test item |
33 µg |
108.3 |
2.1 |
1.0 |
110, 106, 109 |
|||
|
|
100 µg |
103.3 |
5.8 |
0.9 |
100, 100, 110 |
|||
|
|
333 µg |
109.7 |
9.1 |
1.0 |
120, 103, 106 |
|||
|
|
1000 µg |
101.7 |
1.2 |
0.9 |
103, 101, 101 |
|||
|
|
2500 µg |
95.3 |
11.0 |
0.9 |
104, 99, 83 |
|||
|
|
5000 µg |
110.0 |
2.6 |
1.0 |
113, 108, 109 |
|||
|
Deionised water |
|
110.0 |
8.9 |
|
113, 100, 117 |
|||
|
Untreated Control |
|
112.0 |
2.6 |
|
110, 111, 115 |
|||
|
|
|
|
|
|
|
|||
WP2 |
Test item |
33 µg |
64.3 |
16.6 |
1.1 |
66, 47, 80 |
|||
uvrA |
|
100 µg |
68.0 |
8.7 |
1.1 |
78, 63, 63 |
|||
|
|
333 µg |
59.7 |
3.2 |
1.0 |
62, 61, 56 |
|||
|
|
1000 µg |
61.3 |
0.6 |
1.0 |
62, 61, 61 |
|||
|
|
2500 µg |
54.3 |
6.1 |
0.9 |
49, 53, 61 |
|||
|
|
5000 µg |
58.7 |
6.7 |
1.0 |
53, 66, 57 |
|||
|
Deionised water |
|
60.7 |
3.5 |
|
61, 64, 57 |
|||
|
Untreated Control |
|
63.3 |
8.7 |
|
61, 73, 56 |
|||
|
|
|
|
|
|
|
|||
TA 1535 |
2-AA |
2.5 µg |
307.7 |
13.4 |
19.2 |
323, 302, 298 |
|||
TA 1537 |
2-AA |
2.5 µg |
264.7 |
5.8 |
15.6 |
268, 268, 258 |
|||
TA 98 |
2-AA |
2.5 µg |
2864.7 |
116.5 |
65.6 |
2994, 2768, 2832 |
|||
TA 100 |
2-AA |
2.5 µg |
3147.7 |
186.5 |
28.6 |
3039, 3363, 3041 |
|||
WP2 uvrA |
2-AA |
10.0 µg |
366.3 |
1.2 |
6.0 |
365, 367, 367 |
|||
2-AA |
2-aminoanthracene |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five tester strains (TA 98, TA 100, TA 1535, TA 1537 and WP2 uvrA) tested with and without metabolic activation up to 5000 µg/plate.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)