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EC number: - | CAS number: 42355-78-2
- 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:
- From July 08 to August 25, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted July 21, 1997
- Deviations:
- yes
- Remarks:
- deviation had no impact on the outcome of the study (details below)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- deviation had no impact on the outcome of the study (details below)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
- Cas Number:
- 42355-78-2
- Molecular formula:
- C40H40N12Na4O12S4
- IUPAC Name:
- tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
Method
- Target gene:
- his (trp) locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Strains TA 98 and TA 1537 detect frame shift mutations, strains TA 100 and TA 1535 serve to detection of base-pair substitution mutations, and strain E.coli WP2 uvrA detects cross-linking mutagens.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 post mitochondrial fraction
- Test concentrations with justification for top dose:
- First experiment: 50, 150, 500, 1500 and 5000 µg per plate.
As neither precipitation nor toxicity was observed in the first experiments, the second experiments were done with the same dose-range. Experiments with metabolic activation differ from the first by different amount of S9 (30 µl – 5.7 %, 50 µl - 9.5 %, 100 µl – 19.0 %). - Vehicle / solvent:
- Water for injection
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated controls contain no solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 0.1 ml of H2O for injection
- Positive controls:
- yes
- Remarks:
- reference mutagens
- Positive control substance:
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 4-nitro-o-phenylenediamine (NPD), 2-aminofluorene (2-AF), 2-aminoanthracene (2-AA), 9-aminoacridine hydrochloride monohydrate (9-AAc)
- Remarks:
- Without S9: AS 1.5 µg/plate TA100 and TA1535; NPD 20 µg/plate TA98; 9 AAc 100 µg/plate TA1537; ENNG 20 µg/plate E. coli. With S9: 2-AA 1.0 µg/plate TA 1535, 2.5 µg/plate TA1537, 25 µg/plate E. coli; 2-AF 10 µg/plate TA100 and TA98.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar, plate incorporation. 100 µl of test substance of required concentration, 100 µl of 16-18 h culture of tester strain, 0.5 ml relevant buffer and 30 µl of S9 post mitochondrial fraction (in case of test with metabolic activation) were added to the 2 ml of molten top agar (with trace of histidine or tryptophan) kept in a test tube at 45 ± 3 °C. After shaking the mixture was poured into a minimal glucose agar plate.
Fresh solutions of test substance were prepared before each experiment. All concentrations of the test substance solution were dosed in the volume of 0.1 ml per plate.
PREPARATION and USING OF S9: the metabolic activation was performed by S9 fraction of rat liver homogenate and mixture of cofactors. The liver homogenate was prepared from Wistar male rats weighing approximately 200 g, previously induced with Delor 106 (mixture of PCBs). Delor 106 was diluted with olive oil to a concentration of 200 mg/ml, and each rat was administered a single injection of 500 mg/kg 5 days before S9 preparation. The S9 was prepared according to the methods described by Maron and Ames (1983). The liver was removed from each animal and washed in ice cold 0.15 M KCl. The livers washed were mixed with another 0.15 M KCl (3 ml/g wet liver) homogenized in a grinder, and the tissue suspension was centrifuged for 10 min at 9000 g. Aliquots of the supernatant (S9) were stored in plastic tubes using sterile technique at a temperature below –70 °C. Cofactors (NADP and glucoso-6-phosphate) were dissolved in buffer. Each plate in all experiments with metabolic activation contained 0.5 ml of buffer with NADP and glucoso-6-phosphate and 30 µl S9 (the concentration of S9 in the S9mix was 5.7 %). In experiments without metabolic activation only buffer was added to the top agar.
DURATION
- Incubation period: 48 - 72 h at 37 ± 1 °C.
TOXICITY ASSAY: the starting solution (5000 µg/0.1 ml) was diluted to concentration series (10-5000 µg per plate), which was tested for toxicity in strain TA 100 without metabolic activation. No toxicity was observed in any dose.
COUNTER SYSTEM: after incubation the number of revertant colonies on the plate was counted manually with exception of positive controls, which were counted by an AccuCount 1000.
NUMBER OF REPLICATIONS: triplicate plating was used at each dose level except in the toxicity test with strain TA 98, where test substance was tested in duplo. Each experiment was repeated.
GENOTYPES: genotypes of each strain were controlled (plasmid pKM 101 – ampicillin resistance, uvr mutation, rfa mutation, his/trp mutation – spontaneous reversions). - Evaluation criteria:
- The main criterion for evaluation of results was modified two-fold increase rule, which is compatible with the application of statistical methods. After this rule the result is positive, if a reproducible dose-response effect occurs and/or a doubling of the ratio Rt/Rc is reached.
An increase is considered as "biologically relevant":
- if the number of reversions is at least twice as high as that in the solvent control for the strains having spontaneous reversion >10;
- if the number of reversions is at least three times as high as that in the solvent control for the strains having spontaneous reversion ≤10;
A test substance producing neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no evidence of a rising trend in the number of revertants with increasing dose
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no evidence of a rising trend in the number of revertants with increasing dose
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no evidence of a rising trend in the number of revertants with increasing dose
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no evidence of a rising trend in the number of revertants with increasing dose
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no evidence of a rising trend in the number of revertants with increasing dose
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Current historical ranges of revertant numbers in bacterial strains used in the study and live bacteria count used in the first experiments
Control | Spont.rev. | Water | PC -S9 | PC +S9 | Number of CFU/ml |
S.t. TA 100 | 78 - 182 | 87 - 173 | 318 - 826 | 543 - 1571 | 1.06*109 |
S.t. TA 1535 | 10 - 30 | 7 - 30 | 257 - 625 | 68 - 260 | 7.87*108 |
S.t. TA 98 | 12 - 48 | 11 - 49 | 277 - 1557 | 533 - 2181 | 2.13*108 |
S.t. TA 1537 | 5 - 21 | 5 - 22 | 455 - 1399 | 59 - 279 | 7.43*108 |
E.c. WP2 uvrA | 11 - 47 | 12 - 47 | 377 - 1097 | 0 - 387 | 9.40*108 |
Toxicity testing in strain TA 100
Test substance (mg per plate) | Revertants per plate | Rt/Rc | Bacteriotoxic effect | |||
Plates | x±sd | |||||
0 | 128 | 107 | 114 | 116 ± 9 | - | not evaluated |
water | 117 | 99 | 112 | 109 ± 8 | - | not evaluated |
10 | 112 | 105 | NT | 109 ± 4 | 1.0 | bacterial background normal |
100 | 110 | 85 | NT | 98 ± 13 | 0.9 | bacterial background normal |
500 | 101 | 114 | NT | 108 ± 7 | 1.0 | bacterial background normal |
1000 | 137 | 135 | NT | 136 ± 1 | 1.2 | bacterial background normal |
2500 | 107 | 133 | NT | 120 ± 13 | 1.1 | bacterial background normal |
5000 | 113 | 111 | NT | 112 ± 1 | 1.0 | bacterial background normal |
AS | 554 | 603 | NT | 579 ± 25 | 5.3 | not evaluated |
The results obtained in most experiments did not show substantial/biologically significant increases in the number of revertants versus solvent controls (Rt/Rc < 2) and no one of these experiments gave evidence of arising trend in the number of revertants with increasing dose.
Slight increase of number of revertants was observed in both experiments in TA 1537 with metabolic activation in the dose of 50 µg per plate where ratio of revertants against solvent control. Rt/Rc ratio reached 1.5 and 1.4, respectively. This increase is partially caused by lower solvent control compared with spontaneous reversion in both experiments. In the second experiment without metabolic activation slight increase is observed also in the dose of 1500 µg per plate. No such increase was observed in the first experiment. This result is not considered as biologically relevant (see criteria reported above).
Applicant's summary and conclusion
- Conclusions:
- The test substance was non-mutagenic for all the Salmonella typhimurium as well as Escherichia coli strains tested without metabolic activation.
- Executive summary:
Method
The test substance was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The performed test was based on EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471.
Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used. The test substance was dissolved in dimethylsulfoxide and assayed in doses of (10) 50-5000 µg per plate, which were applied to plates in volume of 0.1 ml.
Experiments were performed without as well as with metabolic activation with rat liver and a mixture of cofactors.
Results
The test substance was non-mutagenic for all the Salmonella typhimurium as well as Escherichia coli strains tested without metabolic activation.
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