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EC number: 876-151-9 | CAS number: 2292123-68-1
- 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
- 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:
- July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea
- EC Number:
- 876-151-9
- Cas Number:
- 2292123-68-1
- Molecular formula:
- C27H24N2O7S2
- IUPAC Name:
- N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea
- Test material form:
- solid: particulate/powder
Constituent 1
Method
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:
- Rat liver S9 mix
- Test concentrations with justification for top dose:
- Main test -1 (-/+S9 mix): 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate.
Main test -2 (-/+ S9 mix): 313, 625, 1250, 2500, 5000 µg/plate.
5000µg/plate selected as the highest dose as precipitation of the test item was observed. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test item was insoluble in distilled water at 50 mg/mL. Test item solution of 50 mg/mL was prepared in DMSO. The test item was soluble and considered to be stable from the observations; no colour change, gas generation, etc. Dehydrated DMSO was selected as vehicle as the test item can hydrolyse with strong alkali.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- furylfuramide
- other:
- Remarks:
- 5 positive controls are used
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- preincubation; incorporation in agar and poured on to agar plate
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes at 37°C +/- 0.5°C
- Exposure duration/duration of treatment: Incubation period = 48 hours
- Number of revertant colonies counted after incubation period
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Any supplementary information relevant to cytotoxicity: none observed - Rationale for test conditions:
- As required by the OECD guideline
- Evaluation criteria:
- - Test item was judged to be positive when the number of revertant colonies increased to twice or more than the negative control and when the responses were dose-related and/or reproducible. The other cases were judged to be negative.
- Statistics:
- No statistical methods used
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 2: Main test 1
Test period | From July 26, 2018 to July 30, 2018 | ||||||||||
With (+) or Without (-) S9 mix | Test item dose (µg/plate) | Number of revertant colonies per plate | |||||||||
Base-pair substitution | Frameshift | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
-S9 mix | Negative control | 89 | (90± 7) | 10 | (9 ± 2) | 20 | (24 ± 8) | 18 | (18 ± 4) | 6 | (12 ± 6) |
83 | 7 | 19 | 15 | 12 | |||||||
97 | 10 | 34 | 22 | 18 | |||||||
4.88 | 91 | (96 ± 10) | 11 | (10 ± 2) | 25 | (21 ± 4) | 14 | (17 ± 7) | 13 | (16 ± 4) | |
89 | 10 | 18 | 11 | 21 | |||||||
107 | 8 | 19 | 25 | 15 | |||||||
19.5 | 100 | (93 ± 6 | 7 | (6 ± 1) | 15 | (18 ± 5) | 20 | (17 ± 5) | 15 | (13 ± 4) | |
90 | 7 | 15 | 12 | 8 | |||||||
89 | 5 | 24 | 20 | 15 | |||||||
78.1 | 87 | (85 ± 6) | 10 | (8 ± 3) | 34 | (25 ± 8) | 20 | (15 ± 6) | 14 | (13 ± 2) | |
90 | 4 | 18 | 8 | 11 | |||||||
89 | 10 | 22 | 18 | 14 | |||||||
313* | 93 | (88 ± 13) | 3 | (4 ± 4) | 24 | (20 ± 4) | 15 | (14 ± 1) | 17 | (12 ± 4) | |
98 | 8 | 20 | 13 | 10 | |||||||
74 | 1 | 17 | 13 | 10 | |||||||
1250* | 76 | (82 ± 8) | 4 | (5 ± 1) | 10 | (14 ± 4) | 11 | (10 ± 2) | 8 | (8 ± 1) | |
79 | 6 | 18 | 8 | 7 | |||||||
91 | 5 | 14 | 11 | 9 | |||||||
5000* | 77 | (77 ± 9) | 8 | (7 ± 1) | 28 | (22 ± 6) | 8 | (11 ± 3) | 13 | (11 ± 2) | |
68 | 6 | 16 | 12 | 9 | |||||||
85 | 6 | 23 | 14 | 11 | |||||||
+S9 mix | Negative control | 90 | (89 ± 2) | 6 | (6 ± 2) | 21 | (26 ± 6) | 25 | (22 ± 3) | 17 | (17 ± 5) |
87 | 4 | 24 | 21 | 12 | |||||||
91 | 7 | 32 | 20 | 22 | |||||||
4.88 | 90 | (95 ± 5) | 7 | (10 ± 6) | 29 | (28 ± 4) | 22 | (30 ± 7) | 10 | (14 ± 5) | |
94 | 7 | 24 | 36 | 13 | |||||||
100 | 17 | 32 | 33 | 19 | |||||||
19.5 | 93 | (90 ± 25) | 10 | (11 ± 1) | 22 | (27 ± 4) | 24 | ( 30 ± 7) | 19 | (21 ± 4) | |
85 | 11 | 29 | 29 | 25 | |||||||
85 | 12 | 29 | 38 | 18 | |||||||
78.1 | 119 | (89 ± 11) | 8 | (8 ± 4) | 33 | (32 ± 4) | 26 | (28 ± 7) | 11 | (14 ± 3) | |
78 | 5 | 27 | 22 | 17 | |||||||
74 | 12 | 35 | 36 | 13 | |||||||
313* | 83 | (89 ± 2) | 6 | (9 ± 3) | 20 | (23 ± 3) | 32 | ( 29 ± 7) | 13 | (15 ± 3) | |
83 | 9 | 22 | 21 | 15 | |||||||
102 | 11 | 26 | 34 | 18 | |||||||
1250* | 87 | (86 ± 6) | 4 | (7 ± 4) | 21 | (22 ± 2) | 26 | (22 ± 4) | 11 | (11 ± 1) | |
91 | 5 | 25 | 21 | 11 | |||||||
89 | 11 | 21 | 19 | 10 | |||||||
5000* | 89 | (86 ± 6) | 6 | (6 ± 2) | 17 | (15 ± 2) | 24 | (23 ± 3) | 12 | (13 ± 2) | |
79 | 4 | 14 | 25 | 15 | |||||||
91 | 7 | 14 | 19 | 13 | |||||||
Positive control -S9 mix | Chemical | AF-2 | NaN3 | AF-2 | AF-2 | ICR-191 | |||||
Dose ((µg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 0.5 | ||||||
No. of revertant colonies/plate | 680 | (692 ± 12) | 492 | (492 ± 11) | 122 | (120 ± 8) | 488 | (498 ± 9) | 474 | (482 ± 29) | |
703 | 503 | 111 | 504 | 457 | |||||||
692 | 481 | 127 | 503 | 514 | |||||||
Positive control +S9 mix | Chemical | 2AA | 2AA | 2AA | B[a]P | 2AA | |||||
Dose ((µg/plate) | 1 | 2 | 10 | 5 | 2 | ||||||
No. of revertant colonies/plate | 897 | (896 ± 3) | 191 | (179 ± 11) | 476 | (449 ± 56) | 318 | (302 ± 17) | 167 | (177 ± 25) | |
899 | 169 | 485 | 284 | 206 | |||||||
893 | 177 | 385 | 303 | 159 |
Note: ( ) The mean number of revertant colonies per plate ± standard deviation (n=3)
* Precipitation of the test item was observed in all plates for each tester strain
AF-2: furylfuramide
NaN3: Sodium azide
2AA: 2-aminoanthracene
B[a]P: Benzo[a]pyrene
Table 3: Main test 2
Test period | From August 10, 2018 to August 13, 2018 | ||||||||||
With (+) or Without (-) S9 mix | Test item dose (µg/plate) | Number of revertant colonies per plate | |||||||||
Base-pair substitution | Frameshift | ||||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |||||||
-S9 mix | Negative control | 99 | (94± 4) | 8 | (7 ± 1) | 39 | (44 ± 5) | 29 | (23 ± 10) | 6 | (11 ± 6) |
93 | 6 | 48 | 11 | 11 | |||||||
91 | 8 | 45 | 28 | 17 | |||||||
313* | 83 | (76 ± 11) | 8 | (8 ± 3) | 32 | (35 ± 3) | 17 | (14 ± 3) | 7 | (8 ± 3) | |
81 | 5 | 37 | 14 | 6 | |||||||
63 | 11 | 36 | 11 | 11 | |||||||
625* | 62 | (75 ± 12) | 5 | (6 ± 3) | 37 | (29 ± 8) | 14 | (11 ± 3) | 8 | (9 ± 3) | |
82 | 9 | 28 | 11 | 12 | |||||||
82 | 4 | 21 | 8 | 7 | |||||||
1250* | 71 | (77 ± 9) | 8 | (8 ± 2) | 36 | (34 ± 2) | 8 | (12 ± 5) | 10 | (7 ± 4) | |
87 | 9 | 32 | 11 | 9 | |||||||
74 | 6 | 35 | 17 | 3 | |||||||
2500* | 74 | (79 ± 4) | 6 | (5 ± 2) | 42 | (37 ± 5) | 15 | (13 ± 2) | 4 | (4 ± 1) | |
80 | 2 | 35 | 13 | 5 | |||||||
78 | 6 | 33 | 12 | 4 | |||||||
5000* | 87 | (82 ± 5) | 7 | (8 ± 3) | 42 | (38 ± 7) | 15 | (13 ± 2) | 5 | (4 ± 1) | |
80 | 12 | 30 | 11 | 4 | |||||||
78 | 6 | 42 | 14 | 4 | |||||||
+S9 mix | Negative control | 85 | (88 ± 9) | 7 | (14 ± 7) | 29 | (40 ± 14) | 26 | (26 ± 6) | 10 | (13 ± 4) |
80 | 20 | 55 | 21 | 18 | |||||||
98 | 15 | 35 | 32 | 12 | |||||||
313* | 72 | (73 ± 5) | 5 | (6 ± 3) | 33 | (37 ± 4) | 21 | (27 ± 6) | 15 | (18 ± 4) | |
78 | 3 | 37 | 27 | 23 | |||||||
69 | 9 | 41 | 33 | 17 | |||||||
625* | 77 | (81 ± 3) | 14 | (8 ± 6) | 28 | (35 ± 7) | 29 | (32 ± 6) | 14 | (13 ± 1) | |
83 | 6 | 41 | 38 | 14 | |||||||
83 | 3 | 38 | 28 | 12 | |||||||
1250* | 92 | (79 ± 14) | 4 | (9 ± 5) | 32 | (34 ± 3) | 24 | (26 ± 3) | 13 | (10 ± 3) | |
64 | 14 | 34 | 25 | 7 | |||||||
80 | 8 | 37 | 30 | 9 | |||||||
2500* | 60 | (76 ± 15) | 4 | (7 ± 3) | 39 | (44 ± 5) | 15 | (20 ± 5) | 9 | (10 ± 2) | |
81 | 9 | 48 | 20 | 9 | |||||||
88 | 9 | 44 | 24 | 13 | |||||||
5000* | 69 | (69 ± 4) | 5 | (7 ± 3) | 36 | (32 ± 4) | 28 | (23 ± 4) | 8 | (9 ± 3) | |
73 | 7 | 20 | 22 | 13 | |||||||
65 | 10 | 31 | 20 | 7 | |||||||
Positive control -S9 mix | Chemical | AF-2 | NaN3 | AF-2 | AF-2 | ICR-191 | |||||
Dose ((µg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 0.5 | ||||||
No. of revertant colonies/plate | 943 | (966 ± 57) | 340 | (353 ± 19) | 141 | (125 ± 14) | 420 | (416 ± 11) | 442 | (458 ± 16) | |
1031 | 344 | 121 | 424 | 473 | |||||||
925 | 374 | 113 | 404 | 459 | |||||||
Positive control +S9 mix | Chemical | 2AA | 2AA | 2AA | B[a]P | 2AA | |||||
Dose ((µg/plate) | 1 | 2 | 10 | 5 | 2 | ||||||
No. of revertant colonies/plate | 1230 | (1238 ± 14) | 210 | (187 ± 36) | 574 | (557 ± 31) | 288 | (270 ± 26) | 162 | (157 ± 9) | |
1255 | 146 | 521 | 281 | 147 | |||||||
1230 | 206 | 575 | 240 | 162 |
Note: ( ) The mean number of revertant colonies per plate ± standard deviation (n=3)
* Precipitation of the test item was observed in all plates for each tester strain
AF-2: furylfuramide
NaN3: Sodium azide
2AA: 2-aminoanthracene
B[a]P: Benzo[a]pyrene
Table 4: Historical data (Main test 1) Negative control (Mean+/-3 S.D.)
| -S9 mix | +S9 mix | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |
Mean | 118 | 10 | 33 | 20 | 11 | 109 | 10 | 29 | 27 | 12 |
S.D. | 18 | 4 | 12 | 6 | 4 | 17 | 3 | 11 | 7 | 4 |
Upper limit | 172 | 22 | 69 | 38 | 23 | 160 | 19 | 62 | 48 | 24 |
Lower limit | 64 | 1 | 1 | 2 | 1 | 58 | 1 | 1 | 6 | 1 |
Table 5: Historical data (Main test 1) Positive control (Mean+/-3 S.D.)
| -S9 mix | +S9 mix | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |
Chemical | AF-2 | NaN3 | AF-2 | AF-2 | ICR-191 | 2AA | 2AA | 2AA | B[a]P | 2AA |
Dose (µg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 0.5 | 1 | 2 | 10 | 5 | 2 |
Mean | 869 | 282 | 145 | 463 | 604 | 1476 | 237 | 458 | 264 | 205 |
S.D. | 89 | 47 | 29 | 56 | 95 | 261 | 35 | 121 | 36 | 38 |
Upper limit | 1136 | 423 | 232 | 631 | 889 | 2259 | 342 | 821 | 372 | 319 |
Lower limit | 602 | 141 | 58 | 295 | 319 | 693 | 132 | 95 | 156 | 91 |
Test period from January – June 2018, negative control and positive control with S9 mix
Test period from February – June 2018, positive control without S9 mix
Table 6: Historical data (Main test 2) Negative control (Mean+/-3 S.D.)
| -S9 mix | +S9 mix | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |
Mean | 115 | 10 | 31 | 20 | 11 | 107 | 10 | 28 | 27 | 12 |
S.D. | 18 | 3 | 9 | 6 | 5 | 17 | 3 | 9 | 8 | 8 |
Upper limit | 169 | 19 | 58 | 38 | 26 | 158 | 19 | 55 | 51 | 27 |
Lower limit | 61 | 1 | 4 | 2 | 1 | 56 | 1 | 1 | 3 | 1 |
Table 7: Historical data (Main test 2) Positive control (Mean+/-3 S.D.)
| -S9 mix | +S9 mix | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |
Chemical | AF-2 | NaN3 | AF-2 | AF-2 | ICR-191 | 2AA | 2AA | 2AA | B[a]P | 2AA |
Dose (µg/plate) | 00.1 | 0.5 | 0.01 | 0.1 | 0.5 | 1 | 2 | 10 | 5 | 2 |
Mean | 856 | 289 | 141 | 463 | 599 | 1421 | 232 | 452 | 263 | 198 |
S.D. | 99 | 54 | 29 | 54 | 103 | 308 | 39 | 120 | 37 | 41 |
Upper limit | 1153 | 451 | 228 | 625 | 908 | 2345 | 349 | 812 | 374 | 321 |
Lower limit | 559 | 127 | 54 | 301 | 290 | 497 | 115 | 92 | 152 | 75 |
Test period from February 2018 – July 2018
Applicant's summary and conclusion
- Conclusions:
- The test item had no ability to induce mutations under the test conditions.
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