Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-047-7 | CAS number: 68650-79-3
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 October 2007 - 26 February 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Amides, C18-unsatd., N-[3-(dimethylamino)propyl]
- EC Number:
- 800-353-8
- Cas Number:
- 1379524-06-7
- Molecular formula:
- C23H46N2O, C23H44N2O, C23H42N2O C18-unsat DMAPA condensation product is including the substance with 1, 2 and 3 unsaturations in CIS position.
- IUPAC Name:
- Amides, C18-unsatd., N-[3-(dimethylamino)propyl]
- Test material form:
- other: liquid
- Details on test material:
- Name of test material (as cited in study report): 3-Dimethyl-aminopropyl-ölsäureamide
- CAS Number : 109-28-4
- Physical state: Reddish liquid
- Analytical purity: 78.2 area %
Composition by GC-MS :
• cis-Octadecenoic acid, 3-dimethylaminopropyl amide 78-80 %
• trans-Octadecenoic acid, 3-dimethylaminopropyl amide 0.5 - 2 %
• C16-acid, 3-dimethylaminoproyl amide, 4 isomers 8 - 12 %
• Other carbonic acids, 3-dimethylaminopropyl amide 6-8 %
• Other carbonic acids, 3-dimethylaminopropyl amide 1-2%
- Lot/batch No.: R 401/57
- Storage condition of test material: Ambient (room temperature); under light exclusion; under Nitrogen
1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Minimal Essential Medium (MEM)
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: Yes
- Periodically checked for karyotype stability: Yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (0.75 mg/mL final concentration); S9 fraction was obtained from the liver of rats treated with Phenobarbital i.p. (80 mg/kg bw) and ß-Naphthoflavone p.o.
- Test concentrations with justification for top dose:
- Range finding study: 0.3, 0.6, 1.2, 2.3, 4.7, 9.4, 18.8, 37.5, 75.0 and 150.0 µg/mL; with and without S9 mix (4 h exposure) and without S9 mix (24 h exposure). In earlier range finding study, 39.1 to 5000 µg/mL (with and without S9 mix) was tested and results showed strong cytotoxicity and test item precipitation observed up to 5000 µg/mL.
Based on the results of range finding study, the dose levels selected for main study as follows:
Main study:
- Experiment I* (without S9 mix; 4 h exposure and 18 h preparation interval): 0.7, 1.3, 2.5, 5.0**, 10.0** and 20.0** µg/mL
- Experiment I* (with S9 mix; 4 h exposure and 18 h preparation interval): 0.7, 1.3, 2.5, 5.0, 10.0 and 20.0 µg/mL
- Experiment I (without S9 mix; 4 h exposure and 18 h preparation interval): 1.3, 2.5, 5.0, 10.0, 20.0, 40.0**, 80.0** and 160.0** µg/mL
- Experiment I (with S9 mix; 4 h exposure and 18 h preparation interval): 1.3, 2.5, 5.0, 10.0, 20.0**, 40.0**, 80.0** and 160.0** µg/mL
- Experiment IIA (without S9 mix; 18 h exposure and 18 h preparation interval): 0.31, 0.63, 1.25, 2.5, 5.0 and 10.0 µg/mL
- Experiment IIA (without S9 mix; 28 h exposure and 28 h preparation interval): 1.25, 2.5, 5.0 and 10.0 µg/mL
- Experiment IIA (with S9 mix; 4 h exposure and 28 h preparation interval): 2.5, 5.0, 10.0, 20.0**, 40.0** and 80.0** µg/mL
- Experiment IIB (with S9 mix; 4 h exposure and 28 h preparation interval): 10.0, 15.0, 20.0, 25.0, 30.0** and 35.0** µg/mL
* repeated due to missing cytotoxicity; ** precipitation occurred 4 h after start of treatment - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
- Justification for choice of solvent/vehicle: The solvent was chosen to its solubility properties and its relative non-toxicity to the cell cultures.
- On the day of the experiment (immediately before treatment), the test item was dissolved in ethanol. The final concentration of ethanol in the culture medium was 0.5 % (v/v).
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol 0.5 % (v/v)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethane sulfonate at 500-900 µg/mL
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol 0.5 % (v/v)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: cyclophosphamide at 1.4-2.0 µg/mL
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- PREPARATION OF CULTURES:
- Thawed stock cultures were propagated at 37 °C in 80 cm^2 plastic flasks. About 5 x 10^5 cells per flask were seeded into 15 mL of MEM supplemented with 10 % fetal calf serum. The cells were sub-cultured twice weekly. The cell cultures were incubated at 37 °C in a humidified atmosphere with 1.5 % carbon dioxide (98.5 % air).
METHOD OF APPLICATION: In MEM with 10 % FCS (complete medium)
DURATION
- Exposure duration: Experiment I: 4 h (±S9); Experiment IIA: 18 h (-S9) and 28 h (-S9); Experiment IIA and IIB: 4 h (+S9)
- Fixation time (start of exposure up to harvest of cells): Experiment I: 18 h (±S9); Experiment IIA: 18 h (-S9) and 28 h (-S9); Experiment IIA and IIB: 28 h (+S9)
SPINDLE INHIBITOR (cytogenetic assays): Mitotic activity was arrested by addition of colcemid at 0.2 µg/mL culture medium, 2.5 h before the harvest.
STAIN (for cytogenetic assays): Giemsa staining
NUMBER OF REPLICATIONS: Duplicate cultures for test item, vehicle and positive control groups
NUMBER OF CELLS EVALUATED:
- Cytotoxicity of the test item was evaluated using the mitotic index (% cells in mitosis), which indicates whether an item induces mitotic inhibition. The mitotic index was determined in a sample of 1000 cells per culture of each test group.
- At least 100 metaphases/culture (with 22 ± 1 chromosomes) were scored for chromosomal aberrations. In addition the number of polyploid cells in 500 metaphases per culture was determined (% polyploid metaphases; in the case of this aneuploid cell line polyploid means a near tetraploid karyotype).
DETERMINATION OF CYTOTOXICITY
- Method: Mitotic index
OTHER EXAMINATIONS:
- Breaks, fragments, deletions, exchanges, and chromosome disintegrations were recorded as structural chromosome aberrations. Gaps were recorded as well but not included in the calculation of the aberration rates. - Evaluation criteria:
- A test item is classified as non-clastogenic if:
- the number of induced structural chromosome aberrations in all scored dose groups is in the range of the laboratory's historical control data range (0.0 - 4.0 % aberrant cells, excluding gaps) and/or
- no significant increase of the number of structural chromosome aberrations is observed.
A test item is classified as clastogenic if:
- the number of induced structural chromosome aberrations is not in the range of the laboratory's historical control data range (0.0 - 4.0 % aberrant cells, excluding gaps) and
- either a concentration-related or a significant increase of the number of structural chromosome aberrations is observed.
Statistical significance was confirmed by means of the Fisher's exact test (p < 0.05). However, both biological and statistical significance should be considered together. If the criteria mentioned above for the test item are not clearly met, the classification with regard to the historical data and the biological relevance is discussed and/or a confirmatory experiment is performed.
A test item can be classified as aneugenic if:
- the number of induced numerical aberrations is not in the range of the laboratory's historical control data range (0.0 - 5.2 % polyploid cells). - Statistics:
- Statistical significance was confirmed by means of the Fisher's exact test (p < 0.05).
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- with and without S9 mix
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH and osmolarity: No relevant influence of the test item on the pH value or osmolarity was observed (solvent control 389 mOsm, pH 7.3 versus 407 mOsm and pH 7.4 at 150 µg/mL).
RANGE-FINDING/SCREENING STUDY:
Clear toxic effects were observed after 4 h treatment with 9.4 µg/mL and above in the absence of S9 mix and with 18.8 µg/mL and above in the presence of S9 mix. In addition, 24 h continuous treatment with 4.7 µg/mL and above in the absence of S9 mix induced strong toxic effects. Precipitation of the test item in culture medium was observed after 4 h treatment with 37.5 µg/mL and above in the absence and presence of S9 mix.
PRECIPITATION:
- Experiment I: In the absence of S9 mix, precipitation of the test item in culture medium was observed at preparation interval 18 h with 40 µg/mL & above and in the presence of S9 mix at preparation interval 18 h with 20 µg/mL.
- Experiment IIA: In the presence of S9 mix, precipitation of the test item in culture medium was observed at preparation interval 28 h with 20 µg/mL and above.
- Experiment IIB: In the presence of S9 mix, precipitation of the test item in culture medium was observed at preparation interval 28 h with 30 µg/mL and above.
CYTOTOXICITY:
- Experiment I: Cytotoxicity was observed at 20 µg/mL and above without S9 mix as well as with S9 mix at 40 µg/mL.
- Experiment IIA: Cytotoxicity was observed in the absence of S9 mix after 18 h continuous treatment with 5 µg/mL (1.7 % of control) and after 28 h continuous treatment with 2.5 µg/mL (7.3 % of control).
- Experiment IIB: Cytotoxicity was observed in the presence of S9 mix after 4 h treatment with 30 µg/mL (35.9 % of control) at preparation interval 28 h.
-In addition, reduced mitotic indices were observed after 18 h continuous treatment with 5 µg/mL (33.9 % of control) in Experiment IIA in the absence of S9 mix and after 4 h treatment with 25 µg/mL (49.1 % of control) in the presence of S9 mix at preparation interval 28 h.
COMPARISON WITH HISTORICAL CONTROL DATA:
- Results were compared with the historical data (2005 - 2006) of the laboratory. - Remarks on result:
- other: strain/cell type: Chines hamster V79 cell line
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1/ 2: Summary of results of the chromosome aberration study with Trennmittel ZM 121
Experiments |
Preparation interval |
Test item concentration (µg/mL) |
Polyploid cells (%) |
Cell numbers in % of control |
Mitotic indices in % of control |
Aberrant cells |
||
incl. gaps* |
in % excl. gaps* |
with exchanges |
||||||
Exposure period 4 h without S9 mix |
||||||||
I |
18 h |
Solvent control1 |
2.4 |
100.0 |
100.0 |
5.0 |
3.5 |
0.5 |
Positive control2 |
2.4 |
NT |
96.3 |
10.5 |
10.0** |
5.5 |
||
2.5 |
2.5 |
73.0 |
115.0 |
3.0 |
2.5 |
0.0 |
||
5.0 |
2.4 |
92.9 |
80.0 |
4.5 |
3.5 |
2.0 |
||
10.0 |
1.5 |
73.0 |
65.0 |
4.0 |
2.5 |
0.5 |
||
Exposure period 18 h without S9 mix |
||||||||
IIA |
18 h |
Solvent control1 |
2.4 |
100.0 |
100.0 |
2.5 |
2.5 |
0.0 |
Positive control3 |
2.7 |
NT |
72.1 |
15.0 |
13.5** |
5.5 |
||
1.25 |
3.0 |
98.6 |
104.9 |
3.5 |
3.0 |
0.0 |
||
2.5 |
2.3 |
76.3 |
82.5 |
3.5 |
2.5 |
0.5 |
||
5.0 |
1.7 |
1.7 |
33.9 |
3.0 |
3.0 |
0.0 |
||
Exposure period 28 h without S9 mix |
||||||||
IIA |
28 h |
Solvent control1 |
2.9 |
100.0 |
100.0 |
2.5 |
1.5 |
0.0 |
Positive control3 |
2.8 |
NT |
90.0 |
17.5 |
16.5** |
8.5 |
||
1.25 |
3.2 |
86.9 |
110.8 |
2.0 |
1.0 |
0.0 |
||
2.5 |
2.3 |
7.3 |
101.9 |
1.5 |
1.0 |
0.0 |
||
Exposure period 4 h with S9 mix |
||||||||
I |
18 h |
Solvent control1 |
3.0 |
100.0 |
100.0 |
3.0 |
2.5 |
0.0 |
Positive control4 |
2.9 |
NT |
64.0 |
11.5 |
11.0** |
3.0 |
||
2.5 |
3.0 |
110.3 |
98.7 |
2.5 |
2.0 |
0.0 |
||
5.0 |
2.8 |
113.3 |
77.3 |
2.5 |
2.0 |
1.0 |
||
10.0 |
4.1 |
93.6 |
83.6 |
2.0 |
2.0 |
0.5 |
||
IIA |
28 h |
Solvent control1 |
1.7 |
100.0 |
100.0 |
2.0 |
2.0 |
0.0 |
Positive control5 |
2.1 |
NT |
106.4 |
13.5 |
13.0** |
3.5 |
||
5.0 |
2.2 |
91.5 |
82.3 |
2.5 |
2.5 |
0.5 |
||
10.0 |
2.4 |
91.3 |
97.7 |
3.0 |
2.0 |
0.5 |
||
20.0P |
2.6 |
72.7 |
75.8 |
6.0 |
5.5** |
1.3 |
||
IIB |
28 h |
Solvent control1 |
1.4 |
100.0 |
100.0 |
2.5 |
2.5 |
0.0 |
Positive control5 |
1.5 |
NT |
88.2 |
10.0 |
10.0** |
2.5 |
||
20.0 |
1.8 |
96.0 |
106.6 |
1.5 |
1.0 |
0.0 |
||
25.0 |
1.5 |
58.6 |
49.1 |
1.0 |
1.0 |
0.0 |
||
30.0P |
2.5 |
35.9 |
66.2 |
4.0 |
4.0 |
1.0 |
* Inclusive cells carrying exchanges; NT- Not tested; P-Precipitation occurred; **- Aberration frequency statistically significant higher than corresponding control values
1: Ethanol 0.5 % (v/v); 2: EMS 900 µg/mL; 3: EMS 500 µg/mL; 4: CPA 1.4 µg/mL; 5: CPA 2 µg/mL
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions, Trennmittel ZM 121 is not considered as clastogenic in Chinese hamster V79 cell lines with and without metabolic activation. - Executive summary:
In an in vitro chromosome aberration test performed according to OECD Guideline 473 and in compliance with GLP, cultured Chinese hamster V79 cells were exposed to N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) at the following concentrations:
Range finding study: 0.3, 0.6, 1.2, 2.3, 4.7, 9.4, 18.8, 37.5, 75.0 and 150.0 µg/mL; with and without S9 mix (4 h exposure) and without S9 mix (24 h exposure). In earlier range finding study, 39.1 to 5000 µg/mL (with and without S9 mix) was tested and results showed strong cytotoxicity and test item precipitation observed up to 5000 µg/mL. Based on the results of range finding study, the dose levels selected for main study as follows:
Main study:
- Experiment I (without S9 mix; 4 h exposure + 14 h recovery period): 0.7, 1.3, 2.5, 5.0, 10.0 and 20.0 µg/mL
- Experiment I (with S9 mix; 4 h exposure + 14 h recovery period): 0.7, 1.3, 2.5, 5.0, 10.0 and 20.0 µg/mL
- Experiment I (without S9 mix; 4 h exposure + 14 h recovery period): 1.3, 2.5, 5.0, 10.0, 20.0, 40.0, 80.0 and 160.0 µg/mL
- Experiment I (with S9 mix; 4 h exposure + 14 h recovery period): 1.3, 2.5, 5.0, 10.0, 20.0, 40.0, 80.0 and 160.0 µg/mL
- Experiment IIA (without S9 mix; 18 h exposure without recovery period): 0.31, 0.63, 1.25, 2.5, 5.0 and 10.0 µg/mL
- Experiment IIA (without S9 mix; 28 h exposure without recovery period): 1.25, 2.5, 5 and 10 µg/mL
- Experiment IIA (with S9 mix; 4 h exposure and 24 h recovery period): 2.5, 5.0, 10.0, 20.0, 40.0 and 80.0 µg/mL
- Experiment IIB (with S9 mix; 4 h exposure and 24 h recovery period): 10.0, 15.0, 20.0, 25.0, 30.0 and 35.0 µg/mL
Mitotic activity was arrested by addition of colcemid at 0.2 µg/mL culture medium, 2.5 h before the harvest. The cells were then treated with a hypotonic solution, fixed, stained and examined for mitotic indices and chromosomal aberrations. Metabolic activation system used in this test was 0.75 mg/mL (final concentration). S9 fraction was obtained from the liver of rats treated with Phenobarbital i.p. (80 mg/kg bw) and and ß-Naphthoflavone p.o.
In Experiment I, without S9 mix precipitation of the test item in culture medium was observed at preparation interval 18 h with 40 µg/mL & above and with S9 mix at preparation interval 18 h with 20 µg/mL. In Experiment IIA, with S9 mix precipitation of the test item in culture medium was observed at preparation interval 28 h with 20 µg/mL and above. In Experiment IIB, with S9 mix precipitation of the test item in culture medium was observed at preparation interval 28 h with 30 µg/mL and above. In Experiment I, cytotoxicity was observed at 20 µg/mL and above without S9 mix as well as with S9 mix at 40 µg/mL. In Experiment IIA, cytotoxicity was observed in the absence of S9 mix after 18 h continuous treatment with 5 µg/mL (1.7 % of control) and after 28 h continuous treatment with 2.5 µg/mL (7.3 % of control). In Experiment IIB, cytotoxicity was observed in the presence of S9 mix after 4 h treatment with 30 µg/mL (35.9 % of control) at preparation interval 28 h. In addition, reduced mitotic indices were observed after 18 h continuous treatment with 5 µg/mL (33.9 % of control) in Experiment IIA in the absence of S9 mix and after 4 h treatment with 25 µg/mL (49.1 % of control) in the presence of S9 mix at preparation interval 28 h. In Experiment I, in the absence and the presence of S9 mix and in Experiment IIA, in the absence of S9 mix no clastogenicity was observed up to the highest evaluable concentrations. In contrast, in Experiment IIA, in the presence of S9 mix the number of aberrant cells, excluding gaps was statistically significantly increased at the highest evaluated concentration (20 µg/mL); this value (5.5 % aberrant cells, excluding gaps) slightly exceeded the laboratory’s historical control data range (0.0 - 4.0 % aberrant cells, excluding gaps). In the confirmatory Experiment IIB this finding could not be verified. No relevant increase in the frequencies of polyploidy metaphases was found after treatment with the test item as compared to the frequencies of the controls. The positive control substances, ethylmethane sulfonate (500 or 900 µg/mL, without S9 mix) and cyclophosphamide (1.4 or 2.0 µg/mL, with S9 mix) gave the expected statistically significant increases in the number of cells with structural chromosome aberrations, which demonstrates the sensitivity of the test system.
Under the test conditions, N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) is not considered as clastogenic in Chinese hamster V79 cell lines with and without metabolic activation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.