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EC number: 256-881-9 | CAS number: 50977-10-1
- 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:
- 07-Jun-2010 to 17-Jun-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(isotridecyloxy)propylamine
- EC Number:
- 256-881-9
- EC Name:
- 3-(isotridecyloxy)propylamine
- Cas Number:
- 50977-10-1
- Molecular formula:
- C16H35NO
- IUPAC Name:
- 3-(isotridecyloxy)propan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): 3-(Isotridecyloxy)-1-propane amine
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1
Preliminary test (without and with S9) TA100 and WP2uvrA: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
Main study: TA1535, TA1537 and TA98:
Without and with S9-mix: 0.3, 1, 3, 10, 33 and 100 µg/plate
Experiment 2:
TA1535, TA1537, TA98 and TA100
Without S9-mix: 0.1, 0.3, 1, 3, 10 and 33 µg/plate
With S9-mix: 0.3, 1, 3, 10, 33 and 100 µg/plate
WP2uvrA
Without S9-mix: 0.3, 1, 3, 10, 33 and 100 µg/plate
With S9-mix: 1, 3, 10, 33, 100 and 333 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: Test compound was stable and soluble in ethanol and ethanol has been accepted and approved by authorities and international guidelines
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9
Migrated to IUCLID6: 5 µg/plate in saline for TA1535
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9
Migrated to IUCLID6: 60 µg/plate in water for TA1537
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9
Migrated to IUCLID6: 10 µg/plate in DMSO for TA98
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9
Migrated to IUCLID6: 650 µg/plate in DMSO for TA100
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9
Migrated to IUCLID6: 10 µg/plate in DMSO for WP2uvrA
- Positive control substance:
- other: 2-aminoanthracene in DMSO for all tester strains
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hour
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive if:
a) A two-fold (TA100) or more or a three-fold (TA1535, TA1537, TA98, WP2uvrA) or more increase above solvent control in the mean number of revertant colonies is observed in the test substance group.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Slight precipitation was observed at dose levels of 3330 and 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- In tester strain TA100, toxicity was observed at dose levels of 33 and 100 μg/plate and above in the absence and presence of S9-mix, respectively. In tester strain WP2uvrA, toxicity was observed at dose levels of 100 μg/plate and above in the absence and presence of S9-mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
TA1535: without S9: 33 µg/plate and above and with S9: 33 µg/plate and above
TA1537: without S9: 33 µg/plate and above and with S9: 33 µg/plate and above
TA98: without S9: 33 µg/plate and above and with S9: 33 µg/plate and above
TA100: without S9: 33 µg/plate and above and with S9: 100 µg/plate and above
WP2uvrA: without S9: 100 µg/plate and above and with S9: 100 µg/plate and above
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of this study it is concluded that 3-(Isotridecyloxy)-1-propane amine is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
Evaluation of the mutagenic activity of 3-(lsotridecyloxy)-1-propane amine in theSalmonella typhimuriumreverse mutation assay and theEscherichia colireverse mutation assay (with independent repeat).
3-(lsotridecyloxy)-1-propane amine was tested in theSalmonella typhimuriumreverse mutation assay with four histidine-requiring strains ofSalmonella typhimurium(TA1535, TA1537, TA98 and TA100) and in theEscherichia colireverse mutation assay with a tryptophan-requiring strain ofEscherichia coli(WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital andβ-naphthoflavone).
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch 5001287 of 3-(Isotridecyloxy)-1-propane amine was a clear colourless liquid with a purity of 95.8% m/m (NMR). The test substance was dissolved in ethanol.
In the dose range finding test, 3-(lsotridecyloxy)-1-propane amine was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA.
3-(Isotridecyloxy)-1-propane amine precipitated on the plates at dose levels of 3330 µg/plate and upwards. The bacterial background lawn was reduced or absent at concentrations of 33 µg/plate and upwards in tester strain TA100 and at concentrations of 100 µg/plate and upwards in tester strain WP2uvrA. Since there were too many toxic dose levels in tester strain TA100 this part of the study was repeated in the first mutation assay. Results of WP2uvrA in the dose range finding test were reported as part of the first experiment of the mutation assay.
Based on the results of the dose range finding test, 3-(lsotridecyloxy)-1-propane amine was tested in the first mutation assay at a concentration range of 0.3 to 100 µg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537, TA98 and TA100.
Cytotoxicity was observed in all tester strains. In an independent repeat of the assay with additional parameters, 3-(lsotridecyloxy)-1-propane amine was tested in the absence and presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. The table below gives an overview of the concentrations tested in the second mutation assay. Cytotoxicity was observed in all tester strains.
Tester strains
Metabolic activation
Concentration range (µg/plate)
TA1535, TA1537, TA98 and TA100
-
10% (v/v) S9
Up to 33 IJg/plate
Up to 100 IJg/plate
WP2uvrA
-
10% (v/v) S9
Up to 100 µg/plate
Up to 333 µg/plate
- no 59-mix added.
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