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EC number: 701-381-2 | CAS number: -
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Tridecylamine, branched and linear
- EC Number:
- 289-185-9
- EC Name:
- Tridecylamine, branched and linear
- Cas Number:
- 86089-17-0
- Molecular formula:
- C10-15 H21-31 NH2
- IUPAC Name:
- tridecylamine, branched and linear
- Reference substance name:
- Amines, C11-C13 (linear and branched) alkyl
- EC Number:
- 701-381-2
- IUPAC Name:
- Amines, C11-C13 (linear and branched) alkyl
- Details on test material:
- - Name of test material (as cited in study report): TRIDECYLAMINE MIXTURE OF ISOMERS
- Physical state: Liquid, Colourless, clear
- Analytical purity: 99.7 corr. area-% as a mixture of isomers (see analytical report, BASF study code 10L00059)
- Lot/batch No.: 00/0693-2 Batch: 000STD77L0
- Expiration date of the lot/batch: January 26, 2012
- Stability under test conditions: yes
- Storage condition of test material: At room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- HPRT (hypoxanthine-guanine phosphoribosyl transferase)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Thawed stock cultures are propagated at 37 °C in 80 cm2 plastic flasks (GREINER, 72632 Frickenhausen, Germany). About 5×105 cells are seeded into each flask with 15 mL of MEM (minimal essential medium; SEROMED, 12247 Berlin, Germany) supplemented with 10 % foetal calf serum (FCS, PAA Laboratories GmbH, 35091 Cölbe, Germany) and 1 % neomycin. The cells are subcultured twice weekly. The cell cultures are incubated at 37 °C in a 4.5 % carbon dioxide atmosphere (95.5 % air).
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 Mix
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO; ethanol; Nutrient medium
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Evaluation criteria:
- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible positive response for one of the test points.
A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered to be non-mutagenic in this system.
A mutagenic response is described as follows:
The test item is classified as mutagenic if it induces reproducibly with one of the concen-trations a mutation frequency that is three times higher than the spontaneous mutation fre-quency in the experiment.
The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.
However, in a case by case evaluation this decision depends on the level of the corre-sponding solvent control data. If there is by chance a low spontaneous mutation rate in the range normally found (0.6 – 31.7 mutants per 106 cells), a concentration-related in-crease of the mutations within this range has to be discussed. The variability of the muta-tion rates of solvent controls within all experiments of this study is also taken into consideration. - Statistics:
- A linear regression (least squares) will be performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT®11 (SYSTAT Software, Inc., 501, Canal Boulevard, Suite C, Richmond, CA 94804, USA) statistics software. The number of mutant colonies obtained for the groups treated with the test item will be compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05. However, both, biological and statistical significance will be considered to-gether.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Excessive cytotoxicity at 2 or 4µg/mL without S9 after treatment for 4h or 24h, respectively, and at 14µg/mL with S9
Any other information on results incl. tables
relative | relative | mutant | relative | relative | mutant | |||||
conc. µg | S9 | cloning | cloning | colonies/ | induction | cloning | cloning | colonies/ | induction | |
per mL | mix | efficiency I | efficiency II | 10^6 cells | factor | efficiency I | efficiency II | 10^6 cells | factor | |
% | % | % | % | |||||||
Column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
Experiment I / 4 h treatment | culture I | culture II | ||||||||
Solvent control with ethanol | - | 100.0 | 100.0 | 12.4 | 1.0 | 100.0 | 100.0 | 9.4 | 1.0 | |
Positive control with EMS | 150.0 | - | 99.8 | 53.6 | 178.2 | 14.3 | 80.8 | 88.7 | 96.5 | 10.3 |
Test item | 0.13 | - | 101.3 | 78.0 | 19.6 | 1.6 | 98.7 | 98.5 | 5.3 | 0.6 |
Test item | 0.25 | - | 105.6 | 94.2 | 13.2 | 1.1 | 95.8 | 97.6 | 16.6 | 1.8 |
Test item | 0.5 | - | 94.2 | 34.5 | 39.5 | 3.2 | 100.3 | 44.5 | 12.8 | 1.4 |
Test item | 1.0 | - | 77.1 | 37.7 | 32.2 | 2.6 | 77.4 | 41.1 | 35.6 | 3.8 |
Test item | 2.0 | - | 6.5 | 55.9 | 16.1 | 1.3 | 7.3 | 66.0 | 5.6 | 0.6 |
Test item | 3.0 | - | culture was not continued## | culture was not continued## | ||||||
Test item | 4.0 | - | culture was not continued## | culture was not continued## | ||||||
Solvent control with ethanol | 100.0 | 100.0 | 15.6 | 1.0 | 100.0 | 100.0 | 31.5 | 1.0 | ||
Positive control with DMBA | 1.1 | + | 84.3 | 97.5 | 1033.2 | 66.3 | 73.1 | 88.3 | 1083.7 | 34.4 |
Test item | 0.5 | + | 102.8 | culture was not continued# | 130.6 | culture was not continued# | ||||
Test item | 1.0 | + | 36.8 | 79.6 | 19.7 | 1.3 | 81.1 | 104.7 | 37.5 | 1.2 |
Test item | 2.0 | + | 38.0 | 85.8 | 33.1 | 2.1 | 38.2 | 98.9 | 10.8 | 0.3 |
Test item | 4.0 | + | 31.9 | 105.3 | 36.2 | 2.3 | 35.4 | 91.5 | 18.7 | 0.6 |
Test item | 8.0 | + | 23.4 | 86.4 | 30.2 | 1.9 | 34.7 | 91.3 | 17.0 | 0.5 |
Test item | 12.0 | + | 16.5 | 67.2 | 20.4 | 1.3 | 4.8 | 88.9 | 12.6 | 0.4 |
Test item | 16.0 | + | 0.0 | culture was not continued## | 0.0 | culture was not continued## | ||||
Experiment II / 24 h treatment | culture I | culture II | ||||||||
Solvent control with ethanol | - | 100.0 | 100.0 | 23.8 | 1.0 | 100.0 | 100.0 | 14.1 | 1.0 | |
Positive control with EMS | 150.0 | - | 108.5 | 99.5 | 384.0 | 16.2 | 106.6 | 108.7 | 350.6 | 24.9 |
Test item | 0.13 | - | 107.4 | culture was not continued# | 105.1 | culture was not continued# | ||||
Test item | 0.25 | - | 92.2 | 103.9 | 22.2 | 0.9 | 104.2 | 98.3 | 17.4 | 1.2 |
Test item | 0.5 | - | 102.5 | 85.8 | 25.2 | 1.1 | 115.1 | 70.0 | 19.8 | 1.4 |
Test item | 1.0 | - | 99.3 | 103.6 | 16.2 | 0.7 | 96.1 | 92.9 | 29.8 | 2.1 |
Test item | 2.0 | - | 92.9 | 97.2 | 28.0 | 1.2 | 66.6 | 96.8 | 22.0 | 1.6 |
Test item | 3.0 | - | 26.6 | 89.4 | 29.3 | 1.2 | 12.7 | 101.0 | 14.5 | 1.0 |
Test item | 4.0 | - | 0.0 | culture was not continued## | 0.0 | culture was not continued## | ||||
Experiment II / 4 h treatment | ||||||||||
Solvent control with ethanol | + | 100.0 | 100.0 | 12.4 | 1.0 | 100.0 | 100.0 | 12.0 | 1.0 | |
Positive control with DMBA | 1.1 | + | 52.1 | 90.7 | 880.1 | 70.8 | 39.7 | 73.3 | 731.9 | 60.8 |
Test item | 1.0 | + | culture was not continued# | culture was not continued# | ||||||
Test item | 2.0 | + | 84.3 | 100.7 | 16.8 | 1.4 | 41.6 | 93.3 | 33.3 | 2.8 |
Test item | 4.0 | + | 86.3 | 106.5 | 17.4 | 1.4 | 42.9 | 71.4 | 40.7 | 3.4 |
Test item | 8.0 | + | 71.6 | 96.6 | 20.8 | 1.7 | 39.1 | 100.8 | 15.7 | 1.3 |
Test item | 10.0 | + | 56.2 | 93.8 | 38.3 | 3.1 | 19.4 | 72.5 | 17.2 | 1.4 |
Test item | 12.0 | + | 42.8 | 91.4 | 14.7 | 1.2 | 17.8 | 86.3 | 36.4 | 3.0 |
Test item | 14.0 | + | 1.6 | culture was not continued## | 0.8 | culture was not continued## |
# culture was not continued since a minimum of only four analysable concentrations is required
## culture was not continued due to strong toxic effects
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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