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EC number: 700-093-4 | CAS number: 176969-34-9
- 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:
- 15 Jul - 03 Aug 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 2020
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- adopted in 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Gesundheit und Soziales, Düsseldorf, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
- EC Number:
- 700-093-4
- Cas Number:
- 176969-34-9
- Molecular formula:
- C6H6F2N2O2
- IUPAC Name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
Constituent 1
Method
- Target gene:
- His operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male Sprague-Dawley rats treated with Aroclor 1254.
Prior to first use, each batch was checked for its metabolising capacity by using reference mutagens; appropriate activity was demonstrated. - Test concentrations with justification for top dose:
- First and second experiment: 16, 50, 158, 500, 1581 and 5000 µg/plate with and without metabolic activation
Dose levels were routinely determined on the basis of a standard protocol: If not limited by solubility, 5000 µg/plate or 5 µL/plate were used as highest dose. The results of the first experiment were considered as a pre-test for toxicity. Concentrations of the second experiment were chosed based on the results of the first experiment. - Vehicle / solvent:
- Vehicle/solvent used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- cumene hydroperoxide
- mitomycin C
- other: nitrofurantoin, -S9, 0.2 and 0.4 µg/plate in DMSO for TA100; 4-nitro-1,2-phenylene diamine, -S9, 10 and 20 µg/plate in DMSO for TA1537, 0.5 and 1 µg/plate in DMSO for TA98; 2-aminoanthracene, +S9, 3 and 6 µg/plate in DMSO for all strains
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicates
- Number of independent experiments : 2
METHOD OF APPLICATION: in agar (plate incorporation, Experiment 1) and preincubation (Experiment 2)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 20 min
- Exposure duration: 48 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: Cytotoxicity was determined as background growth inhibition, dose-dependent reduction in mutant count per plate and by titer determination. - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA100 and TA98 this increase should be about twice that of negative controls, whereas for TA1537, at least a threefold increase should be reached. For TA102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA1535 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- evident as a reduction in titer at ≥ 1581 µg/plate for all strains in the first experiment (plate incorporation test) and for strain TA 100 at 5000 µg/plate in the second experiment (pre-incubation test).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
:
- Precipitation and time of the determination: There was no precipitation at any test item concentration in any experiment, neither with nor without S9 mix.
CYTOTOXICITY:
Cytotoxicity, evident as a reduction in titer was noted for all strains in the first experiment at ≥ 1581 µg/plate (plate incorporation test) and for strain TA 100 at 5000 µg/plate in the second experiment (pre-incubation test). There was no inhibition of the bacterial background lawn and no decrease in the number of spontaneous revertant colonies.
HISTORICAL CONTROL DATA: please refer to Table 3 under “Any other information on results incl. tables”
Any other information on results incl. tables
Table 1: Mean number of revertant colonies per plate observed in the first experiment (plate incorporation test)
Concentration (µg/plate) |
TA 1535 | TA 100 | TA 1537 | TA 98 | TA 102 | |||||
Metabolic activation | (-S9) | (+S9) | (-S9) | (+S9) | (-S9) | (+S9) | (-S9) | (+S9) | (-S9) | (+S9) |
DMSO | 8 ± 1 | 11 ± 2 | 110 ± 15 | 177 ± 22 | 6 ± 2 | 8 ± 1 | 23 ± 2 | 39 ± 2 | 294 ± 5 | 313 ± 64 |
16 | 7 ± 1 | 8 ± 1 | 101 ± 19 | 149 ± 23 | 6 ± 2 | 7 ± 1 | 22 ± 6 | 44 ± 7 | 301 ± 34 | 326 ± 76 |
50 | 8 ± 2 | 9 ± 1 | 96 ± 14 | 159 ± 29 | 5 ± 2 | 8 ± 0 | 22 ± 4 | 44 ± 2 | 269 ± 7 | 389 ± 28 |
158 | 8 ± 2 | 9 ± 2 | 102 ± 3 | 144 ± 13 | 5 ± 1 | 7 ± 2 | 21 ± 5 | 46 ± 9 | 279 ± 8 | 280 ± 90 |
500 | 7 ± 2 | 8 ± 2 | 115 ± 2 | 165 ± 21 | 4 ± 1 | 8 ± 1 | 18 ± 3 | 40 ± 4 | 205 ± 3 | 299 ± 51 |
1581 | 7 ± 1 | 8 ± 2 | 96 ± 15 | 114 ± 17 | 4 ± 1 | 8 ± 1 | 22 ± 5 | 43 ± 7 | 195 ± 60 | 333 ± 71 |
5000 | 8 ± 4 | 7 ± 2 | 98 ± 16 | 91 ± 11 | 5 ± 2 | 6 ± 1 | 21 ± 9 | 33 ± 5 | 206 ± 65 | 259 ± 78 |
Positive control# | NaN3 | 2-AA | NF | 2-AA | 4-NPDA | 2-AA | 4-NPDA | 2-AA | MMC | 2-AA |
a) | 772 ± 28 | 113 ± 8 | 300 ± 59 | 1298 ± 138 | 35 ± 3 | 193 ± 38 | 109 ± 7 | 1731 ± 324 | 846 ± 18 | 582 ± 18 |
b) | 917 ± 24 | 82 ± 2 | 398 ± 27 | 1396 ± 258 | 36 ± 8 | 48 ± 6 | 132 ± 6 | 1821 ± 210 | 1003 ± 117 | 1269 ± 170 |
#: NaN3: Sodium azide, NF: Nitrofurantoin, 4-NPDA: 4-Nitro-1,2-phenylene diamine, MMC: Mitomycin C, 2-AA: 2-Aminoanthracene a) lower concentration, 10 µg/plate for NaN3, 0.2 µg/plate for NF, 10µg/plate for 4-NDPA for TA1537, 0.5 µg/plate for TA98, 0.2 µg/plate for MMC, 3 µg/platefor 2-AA b) upper concentration, 20 µg/plate for NaN3, 0.4 µg/plate for NF, 20µg/plate for 4-NDPA for TA1537, 1 µg/plate for TA98, 0.4 µg/plate for MMC, 6 µg/plate for 2-AA |
Table 2: Mean number of revertant colonies per plate observed in the second experiment (pre-incubation test)
Concentration (µg/plate) |
TA 1535 | TA 100 | TA 1537 | TA 98 | plate | |||||
Metabolic activation | (-S9) | (+S9) | (-S9) | (+S9) | (-S9) | (+S9) | (-S9) | (+S9) | (-S9) | (+S9) |
DMSO | 9 ± 3 | 13 ± 3 | 134 ± 24 | 177 ± 21 | 7 ± 1 | 10 ± 3 | 16 ± 1 | 30 ± 4 | 249 ± 20 | 316 ± 11 |
16 | 9 ± 2 | 14 ± 3 | 146 ± 3 | 190 ± 20 | 7 ± 1 | 10 ± 4 | 17 ± 3 | 27 ± 4 | 251 ± 14 | 303 ± 15 |
50 | 8 ± 2 | 13 ± 2 | 131 ± 15 | 191 ± 7 | 7 ± 1 | 8 ± 1 | 17 ± 6 | 34 ± 3 | 251 ± 19 | 277 ± 47 |
158 | 11 ± 3 | 13 ± 2 | 146 ± 27 | 218 ± 21 | 7 ± 1 | 8 ± 1 | 18 ± 5 | 32 ± 2 | 216 ± 15 | 335 ± 18 |
500 | 8 ± 1 | 11 ± 4 | 122 ± 11 | 214 ± 31 | 6 ± 1 | 7 ± 1 | 20 ± 2 | 27 ± 4 | 250 ± 8 | 342 ± 27 |
1581 | 7 ± 2 | 8 ± 1 | 153 ± 5 | 188 ± 3 | 7 ± 2 | 8 ± 3 | 18 ± 1 | 31 ± 4 | 239 ± 9 | 335 ± 13 |
5000 | 8 ± 1 | 11 ± 2 | 132 ± 10 | 173 ± 10 | 7 ± 1 | 7 ± 1 | 19 ± 3 | 26 ± 6 | 254 ± 29 | 277 ± 36 |
Positive control# | NaN3 | 2-AA | NF | 2-AA | 4-NPDA | 2-AA | 4-NPDA | 2-AA | Cumene | 2-AA |
a) | 1074 ± 15 | 112 ± 13 | 503 ± 48 | 2459 ± 451 | 34 ± 2 | 273 ± 36 | 72 ± 6 | 1538 ± 94 | 447 ± 8 | 539 ± 39 |
b) | 850 ± 13 | 68 ± 21 | 927 ± 23 | 2553 ± 325 | 50 ± 4 | 183 ± 12 | 114 ± 17 | 2019 ± 117 | 454 ± 29 | 874 ± 35 |
#: NaN3: Sodium azide, NF: Nitrofurantoin, 4-NPDA: 4-Nitro-1,2-phenylene diamine, 2-AA: 2-Aminoanthracene a) lower concentration, 10 µg/plate for NaN3, 0.2 µg/plate for NF, 10µg/plate for 4-NDPA for TA1537, 0.5 µg/plate for TA98, 50 µg/plate for Cumene, 3 µg/platefor 2-AA b) upper concentration, 20 µg/platefor NaN3, 0.4 µg/plate for NF, 20µg/plate for 4-NDPA for TA1537, 1 µg/plate for TA98, 75µg/plate for Cumene, 6 µg/plate for 2-AA |
Table 3: Historical control data generated in the testing laboratory from 1999 to 2008
1. Plate incorporation method Summary of Historical Negative and Positive Controls |
1999 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
8 |
|
82 |
22 |
7 |
1 |
21 |
3 |
185 |
28 |
DMSO |
- |
8 |
1 |
73 |
13 |
7 |
2 |
17 |
3 |
174 |
30 |
Ethanol |
- |
7 |
- |
99 |
- |
5 |
- |
19 |
- |
292 |
- |
EGDE |
- |
12 |
- |
90 |
- |
6 |
- |
19 |
- |
298 |
- |
DMF |
- |
7 |
- |
70 |
- |
5 |
- |
22 |
- |
198 |
- |
Na-azid |
- |
642 |
79 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
217 |
28 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
105 |
15 |
137 |
20 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
351 |
50 |
Water |
+ |
9 |
2 |
102 |
31 |
7 |
2 |
26 |
7 |
273 |
22 |
DMSO |
+ |
9 |
2 |
92 |
17 |
8 |
1 |
24 |
2 |
248 |
31 |
Ethanol |
+ |
7 |
- |
123 |
- |
8 |
- |
24 |
- |
307 |
- |
EGDE |
+ |
10 |
* |
115 |
- |
8 |
- |
26 |
- |
385 |
- |
DMF |
+ |
10 |
- |
98 |
- |
8 |
- |
24 |
- |
266 |
- |
2-AA |
+ |
184 |
43 |
1290 |
304 |
221 |
57 |
1295 |
194 |
477 |
79 |
2000 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
9 |
1 |
81 |
11 |
7 |
2 |
25 |
6 |
196 |
32 |
DMSO |
- |
9 |
2 |
73 |
17 |
7 |
1 |
23 |
6 |
209 |
30 |
Ethanol |
- |
12 |
- |
97 |
- |
6 |
- |
31 |
- |
209 |
- |
Na-azid |
- |
629 |
70 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
226 |
35 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
106 |
15 |
173 |
21 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
352 |
43 |
Water |
+ |
11 |
1 |
104 |
14 |
10 |
2 |
37 |
5 |
260 |
41 |
DMSO |
+ |
10 |
2 |
94 |
20 |
8 |
2 |
32 |
7 |
270 |
34 |
Ethanol |
+ |
12 |
- |
106 |
- |
13 |
- |
42 |
- |
230 |
- |
2-AA |
+ |
207 |
38 |
1468 |
223 |
252 |
88 |
1524 |
160 |
539 |
66 |
2001 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
9 |
3 |
100 |
22 |
6 |
1 |
39 |
4 |
223 |
42 |
DMSO |
- |
9 |
2 |
100 |
13 |
6 |
2 |
34 |
13 |
208 |
35 |
Acetone |
- |
8 |
- |
113 |
- |
8 |
- |
38 |
- |
233 |
- |
Na-azid |
- |
633 |
76 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
264 |
26 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
94 |
13 |
172 |
19 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
365 |
24 |
Water |
+ |
11 |
2 |
119 |
22 |
9 |
2 |
50 |
6 |
283 |
30 |
DMSO |
+ |
10 |
2 |
125 |
19 |
9 |
2 |
41 |
9 |
267 |
32 |
Acetone |
+ |
12 |
- |
129 |
- |
10 |
- |
45 |
- |
317 |
- |
2-AA |
+ |
193 |
26 |
1614 |
97 |
270 |
78 |
1443 |
67 |
532 |
71 |
2002 |
Compound |
|
|
|
|
Strain |
|
|
|
|
||
and |
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
|||||
S9 Mix |
|
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
Z |
QR |
Water |
- |
14 |
3 |
130 |
29 |
8 |
3 |
35 |
8 |
222 |
50 |
DMSO |
- |
14 |
5 |
136 |
15 |
7 |
2 |
31 |
9 |
216 |
35 |
EGDE |
- |
21 |
7 |
146 |
8 |
8 |
2 |
27 |
5 |
262 |
38 |
Na-azid |
- |
735 |
80 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
323 |
30 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
88 |
11 |
156 |
24 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
556 |
92 |
Water |
+ |
11 |
3 |
151 |
25 |
10 |
2 |
48 |
14 |
275 |
36 |
DMSO |
+ |
12 |
4 |
151 |
19 |
8 |
2 |
39 |
12 |
270 |
24 |
EGDE |
+ |
9 |
3 |
144 |
19 |
7 |
1 |
33 |
6 |
306 |
45 |
2-AA |
+ |
158 |
30 |
1506 |
126 |
256 |
60 |
1283 |
139 |
554 |
64 |
2003 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
14 |
5 |
140 |
20 |
7 |
2 |
28 |
4 |
252 |
44 |
DMSO |
- |
14 |
3 |
144 |
13 |
7 |
1 |
24 |
5 |
227 |
28 |
EGDE |
- |
16 |
2 |
167 |
- |
7 |
- |
26 |
- |
243 |
- |
Ethanol |
- |
14 |
- |
150 |
- |
8 |
- |
18 |
- |
221 |
- |
Acetone |
- |
15 |
- |
134 |
- |
9 |
- |
42 |
- |
279 |
- |
Na-azid |
- |
679 |
90 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
358 |
42 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
91 |
12 |
157 |
18 |
|
|
MMC |
- |
|
|
|
|
|
|
|
|
530 |
63 |
Water |
+ |
13 |
1 |
177 |
30 |
10 |
2 |
41 |
6 |
281 |
32 |
DMSO |
+ |
11 |
2 |
169 |
22 |
9 |
2 |
34 |
6 |
294 |
32 |
EGDE |
+ |
11 |
1 |
184 |
- |
10 |
- |
39 |
- |
280 |
- |
Ethanol |
+ |
25 |
- |
177 |
- |
9 |
- |
38 |
- |
227 |
- |
Acetone |
+ |
10 |
- |
172 |
- |
12 |
- |
31 |
* |
311 |
- |
2-AA |
4- |
170 |
28 |
1526 |
143 |
286 |
78 |
1247 |
138 |
721 |
114 |
2004 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
16 |
3 |
150 |
12 |
8 |
1 |
24 |
7 |
227 |
13 |
DMSO |
- |
16 |
4 |
135 |
15 |
7 |
1 |
26 |
9 |
199 |
14 |
EGDE |
- |
16 |
- |
156 |
- |
7 |
- |
26 |
- |
263 |
- |
Ethanol |
- |
16 |
* |
135 |
- |
7 |
- |
27 |
- |
218 |
- |
Na-azid |
- |
651 |
121 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
339 |
28 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
91 |
18 |
153 |
16 |
|
|
MMC |
- |
|
|
|
|
|
|
|
|
541 |
59 |
Water |
+ |
13 |
2 |
158 |
20 |
11 |
2 |
42 |
11 |
255 |
20 |
DMSO |
+ |
11 |
2 |
153 |
23 |
10 |
2 |
40 |
9 |
255 |
24 |
EGDE |
+ |
12 |
- |
191 |
- |
8 |
- |
48 |
- |
301 |
- |
Ethanol |
+ |
20 |
- |
170 |
- |
10 |
- |
40 |
- |
251 |
- |
2-AA |
+ |
150 |
29 |
1436 |
116 |
259 |
57 |
1164 |
112 |
573 |
79 |
2005 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
19 |
7 |
162 |
22 |
7 |
1 |
25 |
5 |
223 |
20 |
DMSO |
- |
16 |
3 |
142 |
17 |
7 |
1 |
24 |
8 |
214 |
22 |
EGDE |
- |
19 |
3 |
152 |
33 |
7 |
1 |
29 |
7 |
254 |
27 |
Ethanol |
- |
11 |
- |
138 |
- |
7 |
- |
21 |
- |
238 |
- |
DMF |
- |
10 |
- |
125 |
- |
6 |
- |
24 |
- |
212 |
- |
Na-azid |
- |
652 |
66 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
310 |
33 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
89 |
12 |
149 |
17 |
|
|
MMC |
- |
|
|
|
|
|
|
|
|
518 |
38 |
Water |
+ |
13 |
|
205 |
41 |
8 |
1 |
41 |
8 |
260 |
44 |
DMSO |
+ |
11 |
2 |
178 |
22 |
8 |
2 |
44 |
8 |
284 |
30 |
EGDE |
+ |
16 |
2 |
152 |
17 |
8 |
1 |
43 |
7 |
310 |
31 |
Ethanol |
+ |
15 |
- |
127 |
- |
11 |
- |
31 |
- |
287 |
- |
DMF |
+ |
10 |
- |
171 |
- |
7 |
- |
51 |
- |
264 |
- |
2-AA |
|
168 |
28 |
1426 |
142 |
185 |
58 |
1157 |
162 |
718 |
99 |
2006 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
17 |
5 |
139 |
22 |
7 |
1 |
18 |
6 |
205 |
18 |
DMSO |
- |
15 |
3 |
129 |
18 |
7 |
1 |
25 |
7 |
214 |
24 |
EGDE |
- |
20 |
- |
164 |
- |
7 |
- |
37 |
- |
188 |
- |
Na-azid |
- |
654 |
101 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
303 |
37 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
78 |
8 |
142 |
33 |
|
|
MMC |
|
|
|
|
|
|
|
|
|
560 |
222 |
Water |
+ |
11 |
2 |
144 |
28 |
8 |
1 |
28 |
4 |
268 |
26 |
DMSO |
+ |
10 |
2 |
157 |
26 |
8 |
1 |
31 |
7 |
261 |
26 |
EGDE |
+ |
10 |
- |
178 |
- |
8 |
- |
37 |
- |
279 |
- |
2-AA |
+ |
134 |
29 |
1359 |
126 |
181 |
71 |
1017 |
107 |
596 |
105 |
2007 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
16 |
7 |
143 |
19 |
7 |
1 |
24 |
3 |
213 |
13 |
DMSO |
- |
13 |
5 |
138 |
22 |
7 |
1 |
21 |
4 |
237 |
33 |
EGDE |
- |
14 |
- |
119 |
- |
7 |
- |
27 |
- |
186 |
- |
Na-azid |
- |
681 |
127 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
355 |
32 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
87 |
9 |
152 |
15 |
|
|
MMC |
- |
|
|
|
|
|
|
|
|
610 |
72 |
Water |
+ |
11 |
1 |
172 |
33 |
8 |
2 |
34 |
4 |
288 |
37 |
DMSO |
+ |
11 |
2 |
174 |
28 |
9 |
1 |
29 |
5 |
285 |
45 |
EGDE |
+ |
13 |
- |
149 |
- |
10 |
- |
35 |
- |
252 |
- |
2-AA |
+ |
153 |
33 |
1490 |
343 |
173 |
51 |
1079 |
204 |
568 |
105 |
2008 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
13 |
7 |
143 |
21 |
6 |
1 |
24 |
3 |
220 |
15 |
DMSO |
- |
13 |
3 |
149 |
10 |
8 |
1 |
21 |
5 |
250 |
23 |
Ethanol |
- |
14 |
- |
145 |
- |
6 |
- |
29 |
- |
285 |
- |
Acetone |
- |
15 |
- |
108 |
- |
7 |
- |
34 |
- |
225 |
- |
Na-azid1 |
- |
916 |
127 |
|
|
|
|
|
|
|
|
Na-azid2 |
|
979 |
163 |
|
|
|
|
|
|
|
|
NF1 |
- |
|
|
382 |
30 |
|
|
|
|
|
|
NF2 |
|
|
|
563 |
60 |
|
|
|
|
|
|
4-NPDA1 |
- |
|
|
|
|
87 |
10 |
149 |
16 |
|
|
4-NPDA2 |
|
|
|
|
|
161 |
8 |
259 |
15 |
|
|
MMC1 |
- |
|
|
|
|
|
|
|
|
818 |
79 |
MMC2 |
|
|
|
|
|
|
|
|
|
1000 |
35 |
Water |
+ |
11 |
2 |
188 |
9 |
10 |
2 |
33 |
3 |
275 |
35 |
DMSO |
+ |
11 |
1 |
168 |
20 |
10 |
2 |
35 |
6 |
309 |
27 |
Ethanol |
+ |
13 |
- |
142 |
- |
7 |
- |
41 |
- |
359 |
- |
Acetone |
+ |
10 |
- |
139 |
- |
9 |
- |
34 |
- |
291 |
- |
2-AA1 |
+ |
112 |
22 |
2183 |
311 |
185 |
77 |
1619 |
259 |
726 |
74 |
2-AA2 |
|
99 |
28 |
1691 |
374 |
143 |
60 |
1737 |
298 |
1393 |
205 |
1 low dose of respective positive control |
2. Pre-incubation method |
Summary of Historical Negative and Positive Controls |
1999 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
10 |
2 |
117 |
10 |
9 |
2 |
22 |
6 |
247 |
32 |
DMSO |
- |
7 |
2 |
72 |
12 |
6 |
1 |
15 |
3 |
223 |
20 |
Ethanol |
- |
7 |
- |
90 |
- |
7 |
- |
24 |
- |
294 |
- |
EGDE |
- |
10 |
- |
120 |
- |
16 |
- |
13 |
- |
279 |
- |
DMF |
- |
12 |
- |
135 |
- |
9 |
- |
15 |
- |
282 |
- |
Na-azid |
- |
638 |
59 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
258 |
29 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
136 |
17 |
139 |
12 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
525 |
54 |
Water |
+ |
11 |
2 |
144 |
30 |
12 |
2 |
28 |
7 |
294 |
15 |
DMSO |
+ |
8 |
2 |
88 |
13 |
8 |
1 |
23 |
3 |
298 |
22 |
Ethanol |
+ |
11 |
- |
96 |
* |
6 |
- |
28 |
- |
312 |
- |
EGDE |
+ |
11 |
|
173 |
- |
13 |
- |
22 |
- |
329 |
- |
DMF |
+ |
14 |
- |
158 |
- |
12 |
- |
29 |
- |
312 |
- |
2-AA |
+ |
149 |
32 |
1190 |
181 |
203 |
42 |
1117 |
149 |
467 |
53 |
2000 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
11 |
3 |
135 |
8 |
10 |
2 |
24 |
5 |
239 |
23 |
DMSO |
- |
8 |
2 |
80 |
16 |
8 |
2 |
21 |
6 |
237 |
20 |
Ethanol |
- |
9 |
- |
103 |
- |
11 |
- |
44 |
- |
228 |
- |
Na-azid |
- |
620 |
72 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
294 |
55 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
136 |
14 |
176 |
22 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
469 |
43 |
Water |
+ |
12 |
2 |
148 |
15 |
12 |
2 |
31 |
4 |
297 |
28 |
DMSO |
+ |
9 |
1 |
90 |
14 |
9 |
2 |
29 |
6 |
296 |
20 |
Ethanol |
+ |
13 |
- |
127 |
- |
14 |
- |
51 |
- |
211 |
- |
2-AA |
+ |
178 |
36 |
1353 |
213 |
239 |
54 |
1349 |
160 |
466 |
39 |
2001 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
10 |
2 |
121 |
24 |
9 |
1 |
40 |
6 |
269 |
25 |
DMSO |
- |
8 |
2 |
107 |
16 |
7 |
1 |
32 |
6 |
229 |
24 |
Acetone |
- |
13 |
- |
120 |
- |
10 |
- |
37 |
- |
271 |
- |
Na-azid |
- |
614 |
92 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
403 |
44 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
121 |
17 |
182 |
20 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
429 |
48 |
Water |
- |
11 |
1 |
136 |
36 |
10 |
1 |
43 |
9 |
305 |
32 |
DMSO |
+ |
10 |
2 |
123 |
20 |
9 |
2 |
40 |
6 |
281 |
27 |
Acetone |
+ |
15 |
- |
142 |
- |
14 |
- |
51 |
- |
315 |
- |
2-AA |
+ |
196 |
28 |
1627 |
93 |
294 |
46 |
1442 |
120 |
470 |
47 |
2002 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
17 |
5 |
153 |
9 |
8 |
2 |
32 |
13 |
272 |
18 |
DMSO |
- |
12 |
3 |
145 |
13 |
8 |
2 |
29 |
6 |
255 |
32 |
EGDE |
- |
18 |
4 |
158 |
12 |
9 |
2 |
33 |
7 |
264 |
42 |
Na-azid |
- |
740 |
95 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
447 |
31 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
114 |
14 |
165 |
17 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
480 |
35 |
Water |
+ |
15 |
2 |
167 |
20 |
11 |
2 |
45 |
11 |
322 |
19 |
DMSO |
+ |
11 |
2 |
155 |
16 |
9 |
1 |
38 |
9 |
314 |
38 |
EGDE |
+ |
12 |
10 |
179 |
20 |
9 |
2 |
46 |
10 |
342 |
35 |
2-AA |
+ |
170 |
22 |
1550 |
122 |
316 |
57 |
1234 |
149 |
509 |
34 |
2003 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
18 |
2 |
154 |
19 |
10 |
3 |
31 |
10 |
246 |
26 |
DMSO |
- |
15 |
3 |
137 |
18 |
8 |
1 |
20 |
5 |
236 |
24 |
EGDE |
- |
16 |
- |
161 |
- |
8 |
- |
26 |
- |
262 |
- |
Ethanol |
- |
14 |
- |
142 |
- |
7 |
- |
23 |
- |
249 |
- |
Acetone |
- |
20 |
- |
134 |
- |
12 |
- |
33 |
- |
340 |
- |
Na-azid |
- |
664 |
88 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
463 |
37 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
120 |
18 |
164 |
17 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
477 |
44 |
Water |
+ |
13 |
5 |
173 |
32 |
9 |
1 |
39 |
11 |
303 |
63 |
DMSO |
+ |
11 |
2 |
159 |
24 |
9 |
2 |
34 |
5 |
297 |
28 |
EGDE |
+ |
15 |
- |
213 |
|
12 |
- |
52 |
- |
288 |
- |
Ethanol |
+ |
21 |
- |
181 |
- |
8 |
- |
39 |
- |
308 |
- |
Acetone |
+ |
9 |
- |
159 |
- |
17 |
- |
26 |
- |
398 |
- |
2-AA |
+ |
187 |
28 |
1527 |
159 |
345 |
60 |
1255 |
144 |
613 |
94 |
2004 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
18 |
3 |
151 |
9 |
11 |
2 |
25 |
5 |
224 |
14 |
DMSO |
- |
15 |
3 |
134 |
10 |
8 |
1 |
24 |
6 |
209 |
19 |
EGDE |
- |
14 |
• |
148 |
- |
9 |
- |
21 |
- |
253 |
- |
Ethanol |
- |
18 |
- |
130 |
- |
6 |
- |
22 |
- |
218 |
- |
Na-azid |
- |
609 |
107 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
460 |
56 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
111 |
18 |
157 |
18 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
470 |
34 |
Water |
+ |
14 |
2 |
182 |
10 |
10 |
2 |
35 |
5 |
266 |
11 |
DMSO |
+ |
12 |
2 |
156 |
24 |
10 |
2 |
36 |
7 |
251 |
25 |
EGDE |
+ |
13 |
- |
206 |
- |
11 |
- |
51 |
- |
298 |
- |
Ethanol |
+ |
24 |
- |
182 |
- |
9 |
- |
34 |
- |
221 |
- |
2-AA |
+ |
163 |
14 |
1515 |
134 |
293 |
25 |
1145 |
120 |
512 |
56 |
2005 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
18 |
4 |
158 |
15 |
8 |
3 |
29 |
6 |
241 |
38 |
DMSO |
- |
17 |
4 |
144 |
18 |
7 |
2 |
27 |
8 |
228 |
19 |
EGDE |
- |
15 |
- |
144 |
- |
8 |
- |
23 |
- |
239 |
- |
Ethanol |
- |
13 |
- |
139 |
- |
8 |
- |
30 |
- |
260 |
- |
DMF |
- |
12 |
- |
93 |
- |
8 |
- |
32 |
- |
270 |
- |
Na-azid |
- |
637 |
72 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
451 |
44 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
107 |
21 |
155 |
17 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
428 |
39 |
Water |
+ |
14 |
2 |
205 |
30 |
11 |
2 |
44 |
8 |
289 |
47 |
DMSO |
+ |
11 |
3 |
183 |
31 |
9 |
2 |
44 |
7 |
289 |
33 |
EGDE |
+ |
13 |
- |
193 |
- |
11 |
|
32 |
- |
308 |
- |
Ethanol |
+ |
21 |
- |
191 |
- |
10 |
- |
29 |
* |
276 |
- |
DMF |
+ |
10 |
- |
124 |
- |
9 |
- |
51 |
- |
284 |
- |
2-AA |
+ |
161 |
18 |
1448 |
159 |
297 |
46 |
1142 |
97 |
607 |
99 |
2006 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
19 |
5 |
148 |
20 |
7 |
1 |
19 |
7 |
242 |
26 |
DMSO |
- |
15 |
3 |
130 |
14 |
7 |
1 |
19 |
4 |
217 |
23 |
EGDE |
- |
22 |
- |
151 |
- |
7 |
- |
26 |
- |
274 |
- |
Na-azid |
- |
668 |
87 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
444 |
33 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
98 |
10 |
142 |
10 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
443 |
26 |
Water |
+ |
12 |
3 |
182 |
39 |
9 |
1 |
29 |
6 |
275 |
29 |
DMSO |
+ |
10 |
2 |
142 |
28 |
9 |
1 |
30 |
5 |
273 |
29 |
EGDE |
+ |
10 |
- |
191 |
- |
8 |
- |
39 |
- |
252 |
- |
2-AA |
+ |
142 |
25 |
1397 |
101 |
217 |
50 |
982 |
91 |
528 |
62 |
2007 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
16 |
6 |
157 |
20 |
8 |
2 |
26 |
4 |
256 |
37 |
DMSO |
- |
13 |
3 |
137 |
20 |
8 |
1 |
20 |
4 |
237 |
24 |
EGDE |
- |
14 |
- |
160 |
- |
8 |
- |
27 |
- |
284 |
- |
Na-azid |
- |
683 |
118 |
|
|
|
|
|
|
|
|
NF |
- |
|
|
489 |
48 |
|
|
|
|
|
|
4-NPDA |
- |
|
|
|
|
107 |
12 |
156 |
13 |
|
|
Cumene |
- |
|
|
|
|
|
|
|
|
482 |
35 |
Water |
+ |
11 |
2 |
214 |
29 |
9 |
1 |
33 |
4 |
322 |
35 |
DMSO |
+ |
11 |
2 |
176 |
21 |
9 |
2 |
30 |
4 |
293 |
33 |
EGDE |
+ |
13 |
- |
205 |
- |
8 |
- |
34 |
- |
306 |
- |
2-AA |
+ |
150 |
22 |
1473 |
231 |
203 |
54 |
1007 |
172 |
514 |
42 |
2008 |
Compound and S9 Mix |
TA 1535 Z QR |
TA 100 Z QR |
Strain TA 1537 Z QR |
TA 98 Z QR |
TA 102 Z QR |
||||||
Water |
- |
17 |
6 |
151 |
16 |
9 |
1 |
21 |
6 |
249 |
21 |
DMSO |
- |
12 |
5 |
136 |
15 |
8 |
2 |
20 |
4 |
248 |
24 |
Ethanol |
|
16 |
- |
160 |
- |
9 |
- |
30 |
- |
311 |
- |
Acetone |
- |
16 |
- |
145 |
- |
10 |
- |
25 |
- |
216 |
- |
EGDE |
- |
15 |
- |
148 |
- |
8 |
- |
19 |
- |
281 |
- |
Na-azid1 |
- |
869 |
139 |
|
|
|
|
|
|
|
|
Na-azid2 |
|
1063 |
82 |
|
|
|
|
|
|
|
|
NF1 |
- |
|
|
568 |
39 |
|
|
|
|
|
|
NF2 |
|
|
|
884 |
60 |
|
|
|
|
|
|
4-NPDA1 |
- |
|
|
|
|
107 |
12 |
163 |
16 |
|
|
4-NPDA2 |
|
|
|
|
|
211 |
15 |
271 |
13 |
|
|
Cumene1 |
- |
|
|
|
|
|
|
|
|
559 |
52 |
Cumene2 |
|
|
|
|
|
|
|
|
|
595 |
41 |
Water |
+ |
12 |
3 |
178 |
24 |
11 |
2 |
39 |
6 |
310 |
34 |
DMSO |
+ |
13 |
2 |
164 |
28 |
11 |
2 |
33 |
5 |
309 |
28 |
Ethanol |
|
15 |
- |
159 |
- |
13 |
- |
40 |
* |
353 |
- |
Acetone |
+ |
10 |
- |
143 |
- |
11 |
- |
29 |
- |
248 |
- |
EGDE |
+ |
15 |
* |
182 |
- |
14 |
- |
36 |
- |
322 |
- |
2-AA1 |
+ |
132 |
26 |
2244 |
283 |
245 |
67 |
1426 |
246 |
640 |
78 |
2-AA2 |
|
108 |
10 |
1900 |
294 |
81 |
1433 |
1461 |
118 |
1318 |
288 |
1low dose of respective positive control 3 high variations due to cytotoxicity |
Applicant's summary and conclusion
- Conclusions:
- The test item was tested for bacterial mutagenicity in the Ames test according to OECD guideline 471. Under the conditions of the test, the test item was not mutagenic in S. typhimuirum strains TA98, TA100, TA102, TA1535 and TA1537 with and without metabolic activation.
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