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EC number: 440-240-7 | CAS number: 1282554-35-1
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-09-09 to 2010-10-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD 471 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,5´-Bi-1H-Benzimidazole,1,7´-dimethyl-2´-propyl
- IUPAC Name:
- 2,5´-Bi-1H-Benzimidazole,1,7´-dimethyl-2´-propyl
- Test material form:
- not specified
- Details on test material:
- - Storage condition of test material: Room temperature in the dark (ambient humidity)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes- The optical density (OD) at 600 nm of each bacterial culture was determined
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 30, 100, 300, 1000, 3000 µg/plate in the plate test and the preincubation test
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, preincubation)DURATION- Preincubation period: 20 min- Exposure duration: 2 days (TA 102: 3 days)NUMBER OF REPLICATIONS: 3 and 6 for negative controlDETERMINATION OF CYTOTOXICITY- Method: background bacterial lawn
- Evaluation criteria:
- A reproducible, concentration-dependent increase in the number of revertants of at least one tester strain over the vehicle control value and/or outside the historical control data range indicates a genotoxic activity.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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:
- other: historical control data (except for strain TA 102)
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Effects of pH:- Effects of osmolality:- Evaporation from medium:- Water solubility:- Precipitation: at 300 µg/plate and higher- Other confounding effects:RANGE-FINDING/SCREENING STUDIES: In a previous Ames test, The test substance was soluble in DMSO but showed precipitation on plates at concentrations of 1000, 3000 and 5000 μg/plate. Therefore, 3000 μg/plate was investigated as the highest concentration in this study.COMPARISON WITH HISTORICAL CONTROL DATA: yesADDITIONAL INFORMATION ON CYTOTOXICITY: No bacteriotoxicity was observed up to 3000 μg/plate
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
MUTAGENICITY
The OD600 of the individual overnight bacterial cultures varied between 2.3 and 3.0 (raw data). These values correspond to a bacterial titer of ca 100 million/0.1 mL. The test substance did not induce relevant increases in the number of revertant colonies in different tester strains of S. typhimurium compared to the negative control when tested up to 3000 μg/plate in two different experiments. Metabolic activation by S9 mix did not alter the mutation frequency of these bacterial strains under any test conditions used.
The validity of this study is given since the vehicle control plates showed spontaneous revertants in different tester strains of S.typhimurium at frequencies similar to those described in the literature and within the historical negative control data range (99 % lower
limit – 99 % upper limit) experienced in our laboratory., except for slightly higher number of revertants in strain TA 102 in the negative control using the preincubation method. This minor difference was regarded as incidental without any effect on the validity of the study in
view of the clear positive response of the positive control. The mutagens NaN3, 9-AA, 2-NF, MMC and 2-AA showed the expected strain specific responses in the absence and presence of mammalian liver enzymes, respectively, demonstrating the validity of this study.
Table 1: Mutagenic activity of the test substance in S. typhimurium Plate Test (summary of results) Without metabolic activation
µg/plate | Mean Revertants/Plate | ||||
| S. typhimurium | ||||
| TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 |
Negative Control |
|
|
|
|
|
DMSO | 7 | 3 | 14 | 74 | 438 |
Test substance |
|
|
|
|
|
30 | 6 | 5 | 16 | 69 | 459 |
100 | 5 | 6 | 14 | 71 | 452 |
300 | 4 P | 2 P | 26 P | 64 P | 442 |
1000 | 7 P | 5 P | 17 P | 67 P | 418 P |
3000 | 10 P | 5 P | 20 P | 75 P | 322 P |
Positive Control |
|
|
|
|
|
NaN3 (5) | 1016 | - | - | 1124 | - |
9-AA (50) | - | 252 | - | - | - |
2-NF (10) | - | - | 662 | - | - |
MMC (0.5) | - | - | - | - | 1331 |
Table 2: Mutagenic activity of the test substance in S. typhimurium Plate Test (summary of results)With metabolic activation
µg/plate | Mean Revertants/Plate | ||||
| S. typhimurium | ||||
| TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 |
Negative Control |
|
|
|
|
|
DMSO | 13 | 6 | 21 | 91 | 522 |
Test substance |
|
|
|
|
|
30 | 8 | 8 | 17 | 87 | 546 |
100 | 11 | 6 | 15 | 80 | 537 |
300 | 8 P | 4 P | 18 P | 73 P | 516 |
1000 | 8 P | 4 P | 14 P | 82 P | 488 P |
3000 | 7 P | 5 P | 14 P | 86 P | 411 P |
Positive Control |
|
|
|
|
|
2-AA (4) | 186 | 149 | 1286 | 1246 | - |
2-AA (10) | - | - | - | - | 1102 |
Table 3: Mutagenic activity of the test substance in S. typhimurium Preincubation (summary of results) Without metabolic activation
µg/plate | Mean Revertants/Plate | ||||
| S. typhimurium | ||||
| TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 |
Negative Control |
|
|
|
|
|
DMSO | 6 | 5 | 15 | 62 | 427 |
Test substance |
|
|
|
|
|
30 | 8 | 5 | 17 | 60 | 460 |
100 | 6 | 3 | 14 | 59 | 448 |
300 | 7 P | 4 P | 15 P | 56 P | 435 |
1000 | 4 P | 4 P | 15 P | 49 P | 375 P |
3000 | 2 P | 4 P | 15 P | 44 P | 355 P |
Positive Control |
|
|
|
|
|
NaN3 (5) | 1160 | - | - | 1314 | - |
9-AA (50) | - | 255 | - | - | - |
2-NF (10) | - | - | 518 | - | - |
MMC (0.5) | - | - | - | - | 1781 |
Table 4: Mutagenic activity of the test substance in S. typhimurium Preincubation (summary of results) With metabolic activation
µg/plate | Mean Revertants/Plate | ||||
| S. typhimurium | ||||
| TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 |
Negative Control |
|
|
|
|
|
DMSO | 10 | 4 | 16 | 84 | 541 |
Test substance |
|
|
|
|
|
30 | 9 | 5 | 18 | 83 | 572 |
100 | 9 | 2 | 19 | 76 | 558 |
300 | 6 P | 4 P | 17 P | 82 P | 562 |
1000 | 11 P | 3 P | 14 P | 81 P | 523 P |
3000 | 10 P | 3 P | 17 P | 76 P | 493 P |
Positive Control |
|
|
|
|
|
2-AA (4) | 118 | 245 | 1926 | 1662 | - |
2-AA (10) | - | - | - | - | 1394 |
P: Preincubation
-: Not tested
Underlined values are regarded as increased
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negativeThe test substance caused neither base-pair substitutions nor frameshift mutations in different S. typhimurium strains in the presence and absence of metabolic activation when tested up to insoluble concentration. Based on these results it was concluded, that the test substance is "Ames negative".
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