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EC number: 629-754-4 | CAS number: 210988-99-1
- 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:
- 04 Nov 2014 - 13 Nov 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N2-[6-({4,6-bis[butyl(2,2,6,6-tetramethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}(2,2,6,6-tetramethylpiperidin-4-yl)amino)hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine
- EC Number:
- 629-754-4
- Cas Number:
- 210988-99-1
- Molecular formula:
- C82 H156 N18
- IUPAC Name:
- N2-[6-({4,6-bis[butyl(2,2,6,6-tetramethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}(2,2,6,6-tetramethylpiperidin-4-yl)amino)hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine
- Details on test material:
- - Physical state: Solid / white to beige
- Storage condition of test material: Room temperature
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:
- liver S9 mix from phenobarbital and β-naphthoflavone induced rats
- Test concentrations with justification for top dose:
- Standard plate test: 0; 0.1; 0.33; 1.0; 3.3; 10 and 33 μg/plate (without S9 mix); 0; 0.33; 1.0; 3.3; 10; 33 and 100 μg/plate (with S9 mix)
Preincubation test with and without S9 mix: 0; 0.1; 0.33; 1.0; 3.3; 10 and 33 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Sterility control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- see below for details
- Positive control substance:
- other: see below
- Remarks:
- with and without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation; preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: at 37°C for 48 – 72 hours in the dark
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of the background lawn
POSITIVE CONTROLS
The following positive controls were used to check the mutability of the bacteria and the activity of the S9 mix:
With S9 mix
• 2-aminoanthracene (2-AA) (Sigma-Aldrich; 96%)
- 2.5 μg/plate, dissolved in DMSO, with strains: TA 1535, TA 100, TA 1537, TA 98
- 60 μg/plate, dissolved in DMSO, with strain: Escherichia coli WP2 uvrA
Without S9 mix
• N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) (Fluka; 97%)
- 5 μg/plate, dissolved in DMSO, with strains: TA 1535, TA 100
• 4-nitro-o-phenylenediamine (NOPD) (Sigma-Aldrich; 98%)
- 10 μg/plate, dissolved in DMSO, with strain: TA 98
• 9-aminoacridine (AAC) (Sigma-Aldrich; 98%)
- 100 μg/plate, dissolved in DMSO, with strain: TA 1537
• 4-nitroquinoline-N-oxide (4-NQO) (Sigma-Aldrich; 98%)
- 5 μg/plate, dissolved in DMSO, with strain: E. coli WP2 uvrA - Evaluation criteria:
- The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control data range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- strong bacteriotoxicity was observed depending on the strain and test conditions from about 1.0 μg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found at 5000 μg/plate onward with and without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A strong bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed in the standard plate test depending on the strain and test conditions from about 33 μg/plate onward.
In the preincubation assay strong bacteriotoxicity (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed depending on the strain and test conditions from about 1.0 μg/plate onward. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experimental Result
Experiment I (Standard Plate Test):
Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | ||||||
TA 98 | TA 100 | TA 1535 | TA 1537 | WP2uvrA | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 19.3 | 27.0 | 29.0 | 45.0 | 10.0 | 26.3 | 8.0 | 8.0 | 52.3 | 64.0 |
33 | 15.7 | 23.3 | 11.0 | 11.0 | 8.3 | 18.7 | 5.0 | 7.7 | 45.7 | 57.7 |
100 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 12.0 | 0.0 | 0.0 | 0.0 | 40.3 |
333 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
1000 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
2500 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
5000 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
positive control | 369.3 | 1898.7 | 3138.3 | 457.0 | 4254.0 | 200.3 | 1323.3 | 189.7 | 986.3 | 269.3 |
Experiment II (Standard Plate Test):
Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | ||||||
TA 98 | TA 100 | TA 1535 | TA 1537 | WP2uvrA | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 23.3 | 31.7 | 11.7 | 10.0 | 58.7 | |||||
0.1 | 25.3 | 25.3 | 31.0 | 34.3 | 10.7 | 12.3 | 9.3 | 11.0 | 60.7 | 67.0 |
0.33 | 23.0 | 24.7 | 32.7 | 38.3 | 10.3 | 10.0 | 11.0 | 11.7 | 57.7 | 70.3 |
1.0 | 30.3 | 25.7 | 43.7 | 33.3 | 9.0 | 9.0 | 13.3 | 12.3 | 56.0 | 62.3 |
3.3 | 26.3 | 21.3 | 35.0 | 30.3 | 10.7 | 8.3 | 9.0 | 9.7 | 62.3 | 65.7 |
10 | 24.0 | 23.3 | 26.0 | 23.0 | 8.0 | 12.0 | 10.0 | 10.7 | 51.7 | 64.7 |
33 | 10.7 | 17.7 | 7.0 | 16.7 | 6.0 | 8.0 | 1.3 | 6.0 | 42.3 | 59.3 |
100 | 0.0 | 0.0 | 2.7 | 0.0 | 13.0 | |||||
positive control | 389.7 | 1986.0 | 4390.3 | 594.3 | 4387.3 | 214.7 | 881.0 | 149.0 | 1034.0 | 240.7 |
Experiment III (Preincubation test):
Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | Mean revertants per plate | ||||||
TA 98 | TA 100 | TA 1535 | TA 1537 | WP2uvrA | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 19.0 | 20.3 | 32.3 | 30.7 | 11.3 | 10.0 | 11.0 | 12.0 | 45.7 | 49.0 |
0.1 | 21.7 | 23.7 | 31.7 | 35.3 | 10.0 | 10.7 | 9.3 | 10.3 | 43.7 | 50.7 |
0.33 | 16.3 | 27.0 | 30.7 | 29.7 | 10.0 | 8.0 | 8.7 | 9.7 | 41.3 | 52.3 |
1.0 | 11.0 | 22.7 | 32.0 | 31.7 | 10.7 | 10.3 | 6.0 | 10.0 | 26.0 | 48.7 |
3.3 | 10.7 | 20.0 | 24.0 | 37.7 | 10.3 | 10.0 | 5.7 | 9.0 | 20.3 | 49.3 |
10 | 11.7 | 23.7 | 12.7 | 26.0 | 4.3 | 9.0 | 6.7 | 11.7 | 26.0 | 51.7 |
33 | 0.0 | 16.3 | 0.0 | 3.0 | 0.0 | 4.3 | 0.0 | 3.3 | 17.3 | 45.0 |
positive control | 343.0 | 1337.7 | 2146.3 | 691.7 | 2203.0 | 216.7 | 678.3 | 126.3 | 456.7 | 206.0 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions chosen here, it is concluded that the test article is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of bacterial strains Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA in a reverse mutation assay. Dose range was 0.1 μg - 5000 μg/plate in the standard plate test and 0.1 μg - 33 μg/plate in the preincubation test. Both tests were performed with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was found at 5000 μg/plate with and without S9 mix. A strong bacteriotoxic effect was observed depending on the strain and test conditions from about 1.0 μg/plate onward. A relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
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