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EC number: 800-153-0 | CAS number: 1313206-64-2
- 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 mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-14 - 2010-04-29
- 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:
- (Z)-N-9-octadecenylpropane-1,3-diamine
- EC Number:
- 230-528-9
- EC Name:
- (Z)-N-9-octadecenylpropane-1,3-diamine
- Cas Number:
- 7173-62-8
- Molecular formula:
- C21H44N2
- IUPAC Name:
- N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diamine
- Details on test material:
- Chemical registery number : 7173-62-8
Chemical name : (Z)-N-9-octadecenylpropane-1,3-diamine
Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.
1
Method
- Target gene:
- Hypoxanthine-guanine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM (minimal essential medium)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix (indued with ß-naphthoflavone and phenobarbital)
- Test concentrations with justification for top dose:
- Experiment I:
-S9: 0.350, 0.425, 0.500, 0.575, 0.650, 0.725, 0.800, 0.875 µg/mL
+S9: 0.05, 0.10, 0.25, 0.5, 1.0, 3.0, 4.0, 5.0 µg/mL
Experiment II:
-S9: 0.1, 0.2, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 µg/mL
+S9: 1.0, 2.0, 3.8, 4.2, 5.0, 5.5, 6.0, 7.0 µg/mL - Vehicle / solvent:
- Ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 300 µg/mL ethylmethanesulphonate (EMS); 1.0 µg/mL (Experiment I) and 1.5 µg/mL (Experiment II) 7,12-dimethylbenzanthracene(DMBA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4, 20 hours
- Expression time (cells in growth medium): 48 to 72 hours after treatment
SELECTION AGENT (mutation assays): thioguanine (TG)
NUMBER OF REPLICATIONS: two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth - Evaluation criteria:
- A mutation assay is considered acceptable if it meets the following criteria:
- negative and/or solvent controls fall within the performing laboratories historical control data range: 1 - 39 mutants/10E6 cells
- the absolute cloning efficiency: ([number of positive cultures x 100] / total number of seeded cultures) of the negative and/or solvent controls is > 50%
- the spontaneous mutant frequency in the negative and/or solvent controls is in the range of historical control data
- the positive controls (EMS and DMBA) induce significant increases (at least 3-fold increase of mutant frequencies related to the comparable negative control values and higher than the historical range of negative controls) in the mutant frequencies.
Atest is considered negative if there is no biological relevant increase in the number of mutants. There are several criteria for determining a positive result:
- a reproducible 3-times higher mutation frequency than the solvent control for at least one of the concentrations
- a concentration related increase of the mutation frequency; such an evaluation may be considered also in the case that a 3-fold increase of the mutant frequency is not observed. - Statistics:
- No data
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: at 0.875 µg/mL (-S9) and at 5.0 µg/mL (+S9); Experiment II: at 0.9 µg/mL (-S9) and at 7.0 µg/mL (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The toxicity of the test item was based on data from pre-experiment. Eight concentrations were tested: 0.0625 - 4.0 µg/mL (-S9) and 0.125 - 3.0 µg/mL (+S9).
In experiment I 0.875 µg/mL (-S9) and 5 µg/mL (+S9) were selected as the highest concentrations. In experiment II 0.9 µg/mL (-S9) and 7 µg/mL [+S9) were selected as the highest concentrations. Experiment II without metabolic activation was performed as a 20 h long-term exposure assay.
COMPARISON WITH HISTORICAL CONTROL DATA:
All values of the negative controls and test item concentrations found were within the historical control data
Any other information on results incl. tables
Table 1: Experiment I - without metabolic activation
Dose Group |
Concentration [µg/mL] |
Relative Growth [%] |
Factor* (survived cells / seeded cells) |
Mutant colonies per 10E6 cells |
Mutation factor |
NC1 |
0 0 |
125.1 |
0.78 |
11.48 |
|
NC2 |
133.3 |
0.82 |
14.58 |
||
S1 |
0 0 |
100.0 100.0 |
0.78 |
14.08 |
|
S2 |
0.69 |
6.48 |
|||
5 |
0.350 |
104.1 |
0.73 |
18.49 |
1.80 |
6 |
0.425 |
98.6 |
0.71 |
25.42 |
2.47 |
7 |
0.500 |
90.9 |
0.81 |
8.07 |
0.79 |
8 |
0.575 |
80.5 |
0.81 |
24.66 |
2.40 |
9 |
0.650 |
53.5 |
0.75 |
22.09 |
2.15 |
10 |
0.725 |
51.9 |
0.74 |
14.29 |
1.39 |
11 |
0.800 |
33.2 |
0.74 |
24.19 |
2.35 |
12 |
0.875 |
13.6 |
0.63 |
3.96 |
0.39 |
EMS |
300 |
105.9 |
0.82 |
150.37 |
14.62 |
Table 2: Experiment I - with metabolic activation
Dose Group |
Concentration [µg/mL] |
Relative Growth [%] |
Factor* (survived cells / seeded cells) |
Mutant colonies per 10E6 cells |
Mutation factor |
NC1 |
0 0 |
103.0 |
0.97 |
10.80 |
|
NC2 |
114.6 |
0.69 |
28.34 |
||
S1 |
0 0 |
100.0 100.0 |
0.84 |
11.96 |
|
S2 |
0.87 |
7.51 |
|||
1 |
0.05 |
97.8 |
0.83 |
21.79 |
2.24 |
2 |
0.10 |
82.0 |
0.72 |
13.81 |
1.42 |
3 |
0.25 |
83.9 |
0.84 |
19.69 |
2.02 |
4 |
0.5 |
79.8 |
0.83 |
7.85 |
0.81 |
5 |
1.0 |
81.3 |
0.71 |
21.86 |
2.25 |
6 |
3.0 |
68.5 |
0.73 |
17.08 |
1.75 |
7 |
4.0 |
47.2 |
0.72 |
22.85 |
2.35 |
8 |
5.0 |
10.1 |
0.57 |
14.13 |
1.45 |
DMBA |
1.0 |
67.0 |
0.68 |
147.19 |
15.12 |
Table 3: Experiment II - without metabolic activation
Dose Group |
Concentration [µg/mL] |
Relative Growth [%] |
Factor* (survived cells / seeded cells) |
Mutant colonies per 10E6 cells |
Mutation factor |
NC1 |
0 0 |
115.5 |
0.87 |
5.74 |
|
NC2 |
105.7 |
0.90 |
11.67 |
||
S1 |
0 0 |
100.0 100.0 |
0.87 |
5.76 |
|
S2 |
0.75 |
10.65 |
|||
5 |
0.1 |
80.6 |
0.56 |
8.06 |
0.98 |
6 |
0.2 |
80.6 |
0.56 |
11.71 |
1.43 |
7 |
0.4 |
67.9 |
0.76 |
1060 |
1.29 |
8 |
0.5 |
62.0 |
0.51 |
13.70 |
1.67 |
9 |
0.6 |
38.2 |
0.94 |
8.55 |
1.04 |
10 |
0.7 |
27.7 |
0.84 |
12.54 |
1.53 |
11 |
0.8 |
26.7 |
0.67 |
2.98 |
0.36 |
12 |
0.9 |
12.6 |
0.99 |
9.06 |
1.10 |
EMS |
300 |
49.3 |
0.57 |
184.12 |
22.44 |
Table 4: Experiment II - with metabolic activation
Dose Group |
Concentration [µg/mL] |
Relative Growth [%] |
Factor* (survived cells / seeded cells) |
Mutant colonies per 10E6 cells |
Mutation factor |
NC1 |
0 0 |
118.5 |
0.75 |
16.02 |
|
NC2 |
96.0 |
0.68 |
8.77 |
||
S1 |
0 0 |
100.0 100.0 |
0.86 |
16.36 |
|
S2 |
0.84 |
1.20 |
|||
2 |
1.0 |
95.0 |
0.70 |
9.34 |
1.06 |
3 |
2.0 |
95.0 |
0.68 |
4.39 |
0.50 |
5 |
3.8 |
85.0 |
0.72 |
6.23 |
0.71 |
6 |
4.2 |
80.0 |
0.74 |
6.11 |
0.70 |
7 |
5.0 |
70.0 |
0.78 |
3.19 |
0.36 |
8 |
5.5 |
65.0 |
0.55 |
2.75 |
0.31 |
9 |
6.0 |
40.0 |
0.75 |
8.70 |
0.99 |
10 |
7.0 |
16.5 |
0.79 |
5.06 |
0.58 |
DMBA |
1.5 |
80.0 |
0.87 |
116.09 |
13.23 |
NC: negative control / medium control
SC: solvent control (ethanol)
*: cloning efficiency x cells seeded
EMS: Ethylmethansulfonate
DMBA: 7,12 -Dimethylbenz(a)anthracene
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the test item N-Oleyl-1,3-diaminopropane is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese hamster.
- Executive summary:
The test item N-Oleyl-1,3-diaminopropane was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster according to the OECD guideline 476.
The main experiments were carried out without and with metabolic activation. The experiments with metabolic activation were performed by including liver microsomes and NADP for efficient detection of a wide variety of carcinogens requiring metabolic activation.
The selection of the concentrations used in the main experiments was based on data from the pre-experiments according to the OECD guideline 476.
In experiment I 0.875 µg/mL (without metabolic activation) and 5.0 µg/mL (with metabolic activation) were selected as the highest concentrations. In experiment II 0.9 µg/mL (without metabolic activation) and 7.0 µg/mL (with metabolic activation) were selected as the highest concentrations. Experiment II without metabolic activation was performed as a 20 h long-term exposure assay.
The pH-value detected with the test item was within the physiological range. The test item was investigated at the following concentrations:
Experiment I
without metabolic activation:
0.350, 0.425, 0.500, 0.575, 0.650, 0.725, 0.800 and 0.875 µg/mL
and with metabolic activation:
0.05, 0.10, 0.25,0.5,1.0, 3.0, 4.0 and 5.0 µg/mL
Experiment II
without metabolic activation:
0.1, 0.2, 0.4, 0.5, 0.6, 0.7, 0.8 and 0.9 µg/mL
and with metabolic activation:
1.0, 2.0, 3.8, 4.2, 5.0, 5.5, 6.0 and 7.0 µg/mL
No precipitation oft he test item was noted in experiment I and experiment II.
Toxicity:
A biologically relevant growth inhibition (reduction of relative growth below 70%) was observed after the treatment with the test item in experiment I and II with and without metabolic activation.
In experiment I without metabolic activation the relative growth was 13.6% for the highest concentration (0.875 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 5.0 µg/mL with a relative growth of 10.1%.
In experiment II without metabolic activation the relative growth was 12.6% for the highest concentration (0.9 µg/mL) evaluated. The highest biologically relevant concentration evaluated with metabolic activation was 7.0 µg/mL with a relative growth of 16 .5%.Mutagenicity:
In experiment I without metabolic activation mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 1 - 39 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the negative controls.
Mutation frequencies with the negative control were found to be 11.48 and 14.58 mutants/106 cells, 14.08 and 6.48 mutants/106 cells for the solvent control and in the range of 3.96 to 25.42 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the solvent control values) of 2.47 was found at a concentration of 0.425 µg/mL with a relative growth of 98.6%.
With metabolic activation all mutant values of the negative controls and test item concentrations found were within the historical control data of the test facility BSL BIOSERVICE (about 2 - 28 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the solvent controls.
Mutation frequencies of the negative control were found to be 10.80 and 28.34 mutants/106 cells, 11.96 and 7.51 mutants/106 cells for the solvent control and in the range of 7.85 to 22.85 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the solvent control values) of 2.35 was found at a concentration of 4.0 µg/mL with a relative growth of 47.2%.
In experiment II without metabolic activation all mutant values found were within the historical control data of the test facility BSL BIOSERVICE (about 1 - 39 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the solvent controls.
Mutation frequencies with the negative control were found to be 5.47 and 11.67 mutants/106 cells, 5.76 and 10.65 mutants/106cells for the solvent control and in the range of 2.98 to 13.70 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the solvent controls values) of 1.67 was found at a concentration of 0.5 µg/mL with a relative growth of 62.0%.
In experiment II with metabolic activation most mutant values found were within the historical control data of the test facility BSL BIOSERVICE (about 2 - 28 mutants per 106 cells). No dose-response relationship could be observed. The mutation frequencies found in the groups treated with the test item did not show a biologically relevant increase as compared to the solvent controls.
Mutation frequencies of the negative control were found to be 16.02 and 8.77 mutants/106 cells, 16.36 and 1.20 mutants/106 cells for the solvent control and in the range of 2.75 to 9.34 mutants/106 cells with the test item, respectively. The highest mutation rate (compared to the solvent control values) of 1.06 was found at a concentration of 1.0 µg/mL with a relative growth of 95%.
DMBA (1.0 and 1.5 µg/mL) and (300 µg/mL) were used as positive controls and showed distinct and biologically relevant effects in mutation frequency.
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