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EC number: 219-145-8 | CAS number: 2372-82-9
- 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:
- From December 17, 2001 to March 25, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Cited as Directive 2000/32/EC, B.13/14
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- EC Number:
- 219-145-8
- EC Name:
- N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
- Cas Number:
- 2372-82-9
- Molecular formula:
- C18H41N3
- IUPAC Name:
- bis(3-aminopropyl)(dodecyl)amine
- Details on test material:
- - Lot/Batch number: FP 020010155
- Triamine content: 85.3%; Total amine content (commercial grade): 100%
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA100, TA98, and TA102.
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 10, 100, 500, 1,000, 2,500 and 5,000 µg/plate, +/- S9.
Main study, with S9:
1st experiment: 6.25, 12.5, 25, 50 and 100 µg/plate (TA 98 and TA 1537), 12.5, 25, 50, 100 and 200 µg/plate (other strains).
2nd experiment: 3.125, 6.25, 12.5, 25 and 50 µg/plate (TA 98, TA 1537 and TA 1535); 12.5, 25, 50, 100 and 200 µg/plate (TA 100 and TA 102)
Main study, without S9:
1st experiment: 12.5, 25, 50, 100 and 200 µg/plate, for all tester strains
2nd experiment: 3.125, 6.25, 12.5, 25 and 50 µg/plate (TA 98, TA 1537 and TA 1535), 12.5, 25, 50, 100 and 200 µg/plate (TA 100 and TA 102). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (TA 1535 and TA 100), 9-aminoacridine (TA 1537), 2-nitrofluorene (TA 98), mitomycin C (TA 102). +S9: 2-anthramine (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plate incorporation and preincubation (experiment 2,+ S9)
The test substance was dissolved in distilled water the vehicle previously heated at approximately 50°C. The preparations were made immediately before use.
- The direct plate incorporation method was performed as follows: test substance solution (0.1 mL), S9 mix when required (0.5 mL) and bacterial suspension (0.1 mL) were mixed with 2 mL of overlay agar (containing traces of the relevant aminoacid and biotin and maintained at 45°C). After rapid homogenization, the mixture was overlaid onto a Petri plate containing minimum medium.
- The preincubation method was performed as follows: test substance solution (0.1 mL), S9 mix (0.5 mL) and the bacterial suspension (0.1 mL) were incubated for 60 minutes at 37°C before adding the overlay agar and pouring onto the surface of a minimum agar plate.
DURATION
- Preincubation period: 60 min (experiment 2, + S9)
- Exposure duration: 48 to 72 h
NUMBER OF REPLICATIONS: 3 plates/dose level in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Decrease in the number of revertant colonies and/or a thinning of the bacterial lawn - Evaluation criteria:
- The study is considered valid if the following criteria are fully met:
- the number of revertants in the vehicle controls is consistent with laboratory historical data;
- the number of revertants in the positive controls is higher than that of the vehicle controls and is consistent with laboratory historical data.
A reproducible two-fold increase in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA100, TA98, and TA102.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 50 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Since the test substance was toxic in the preliminary test, the choice of the highest dose-level for the main test was based on the level of toxicity, according to the criteria specified in the international guidelines.
ADDITIONAL INFORMATION ON CYTOTOXICITY: In the main study in the experiments without S9 mix, a moderate to marked toxicity was induced generally at dose-levels ≥50 μg/plate. In the experiments with S9 mix, a moderate to marked toxicity was induced generally at dose-levels ≥100 μg/plate in the first experiment and ≥50 μg/plate in the second experiment.
In the preliminary cytotoxicity test, with S9, toxicity was induced at dose levels ≥100 µg/plate in TA 98 strain and ≥500 µg/plate in other strains.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was not considered to be mutagenic in the bacterial reverse mutation assay in the presence and absence of S9 mix.
- Executive summary:
An in vitro bacterial reverse mutation study was conducted to determine the mutagenic potential of the test substance according to OECD Guideline 471 and EU method B.13/14, in compliance with GLP. Salmonella typhimurium strains TA 1535, TA 1537, TA100, TA98, and TA102 were exposed to the substance in the presence and absence of S9. The assay was performed in two phases, using the plate incorporation and/or pre-incubation method. The first phase (preliminary toxicity) was to establish the dose-range for the confirmatory assay and to provide a preliminary mutagenicity evaluation. The second phase (confirmatory assay) was to evaluate and confirm the mutagenic potential of the test substance. The main study was conducted in two independent experiments with at least five dose levels of the test substance using three plates/dose-level with and without S9 mix:
Without S9-mix:
First experiment (plate incorporation method): 6.25, 12.5, 25, 50 and 100 µg/plate, for the TA 98 and TA 1537 strains, 12.5, 25, 50, 100 and 200 µg/plate, for the remaining strains.
Second experiment (plate incorporation method): 3.125, 6.25, 12.5, 25 and 50 µg/plate, for the TA 98, TA 1537 and TA 1535 strains, 12.5, 25, 50, 100 and 200 µg/plate, for the TA 100 and TA 102 strains.
With S9 mix:
First experiment (plate incorporation method): 12.5, 25, 50, 100 and 200 µg/plate for all tester strains.
Second experiment (pre-incubation method): 3.125, 6.25, 12.5, 25 and 50 µg/plate, for the TA 98, TA 1537 and TA 1535 strains, 12.5, 25, 50, 100 and 200 µg/plate, for the TA 100 and TA 102 strains). Concurrent solvent (water) and positive controls (without S9: sodium azide (TA 1535 and TA 100), 9-aminoacridine (TA 1537), 2-nitrofluorene (TA 98), mitomycin C (TA 102); with S9: 2-anthramine (all strains), were also included.
In the preliminary toxicity test, no precipitate was observed in the Petri plates when the revertants were scored at all dose levels. Both with and without S9 mix, the test substance was strongly toxic at dose-levels ≥500 µg/plate. In the TA 98 strain, the test substance was also toxic at 100 µg/plate. In the mutagenicity assay, moderate to marked toxicity was induced generally at dose-levels ≥50 µg/plate without S9-mix and at ≥100 µg/plate with S9 mix. No increase in the number of revertants was noted in all tester strains in both the experiments. All the validity criteria were met.
Under the study conditions, the test substance was not considered to be mutagenic in the bacterial reverse mutation assay in the presence and absence of S9 mix (Haddouk, 2002).
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