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EC number: 470-720-1 | CAS number: 189253-72-3
- 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:
- 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Remarks:
- statement
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 470-720-1
- EC Name:
- -
- Cas Number:
- 189253-72-3
- Molecular formula:
- C10H25N3O
- IUPAC Name:
- N-(2-(dimethylamino)ethoxy)ethyl)-N-methyl-1,3-propanediamine
- Details on test material:
- Batch 19902-20
Expiry 31.3.2007
Constituent 1
Method
- Target gene:
- TK
Species / strain
- Species / strain / cell type:
- human lymphoblastoid cells (TK6)
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- Without S9 : From 700 to 1000 micrograms/ml (3h exposure time, 24 h fixation time).
With S9 : From 925 to 1200 microgram/ml (3h exposure time, 24 h fixation time).
Without S9 : From 500 to 1000 micrograms/ml (48h exposure time, 48 h fixation time).
With S9 : From 1000 to 1200 microgram/ml (48 h exposure time, 48 h fixation time).
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Without metabolic activation
Migrated to IUCLID6: 0.5 µg/ml for a 3 h exposure period, 0.2 µg/ml for a 24 h exposure period and 0.1 µg/ml for a 48 h exposure period.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- With metabolic activation (+S9-mix)
Migrated to IUCLID6: 10 µg/ml for a 3 h exposure period (24 h fixation time)l for a 3 h exposure period (24 h fixation time).
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- RPMI 1640 medium
- True negative controls:
- no
- Positive controls:
- no
- Details on test system and experimental conditions:
- Cultured peripheral human lymphocytes were used as test system. Peripheral human lymphocytes are recommended in international guidelines (e.g.OECD and EEC). Blood was collected from healthy adult, non-smoking male volunteers.
- Evaluation criteria:
- A test substance was considered positive (clastogenic) in the chromosome aberration test if:
a) It induced a dose-related statistically significant (Chi-square test, P < 0.05) increase in the number of cells with chromosome aberrations.
b) A statistically significant and biologically relevant increase in the frequencies of the number of cells with chromosome aberrations was
observed in the absence of a clear dose-response relationship.
A test substance was considered negative (not clastogenic) in the chromosome aberration test if none of the tested concentrations induced
a statistically significant (Chi-square test, P c 0.05) increase in the number of cells with chromosome aberrations.
The preceding criteria are not absolute and other modifying factors might enter into the final evaluation decision.
The incidence of aberrant cells (cells with one or more chromosome aberrations, inclusive or exclusive gaps) for each exposure group was compared to that of the solvent control using Chi-square statistics. - Statistics:
- Chi-square statistics.
Effects were considered staticticaly significant if p ≤ 0.05
Results and discussion
Test results
- Species / strain:
- human lymphoblastoid cells (TK6)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The substance did not induce a statistically relevant increase in the number of chromosome aberrations in the absence and presence of S9 mix. The substance increased the number of polyploidy cells and cells with endoreduplication. The substance induced a statistically relevant increase in the number of chromosome aberrations at the highest cytotoxic concentrations only, both when gaps were included and excluded. Since the type of aberrations observed were mainly breaks and gaps the increases were not dose-related and the number of cells with aberrations were within the range of historical controls. The conclusion is that these increases were considered not to be biologically relevant.
In this experiment, it was technically challenging to obtain reproducible results regarding dose ranges associated with the desired level of cytotoxicity (50% decrease in mitotic index). The first experiment required 4 trials in order to obtain the 50% decrease in mitotic index. The second experimen required 6 trials in order to obtain the scorable cells.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
Substance was tested in chromosome aberrations test (OECD 473) using cultured periphesal human lymphocytes. The test is valid and the substance is not clastogenic in human lymphocytes under the experimental conditions, in the presence and absence of S9. Substance may have the potential to disturb mitotic processes and cell cycle progression due to polyploidy and endoreduplication. - Executive summary:
This report describes the effect of the substance on the number of chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (Phenobarbital and B-naphthoflavone induced rat liver S9-mix).
The possible clastogenicity of N- { 2-[2-(Dimethylamine)Ethoxy]Ethyl ) -N-Methyl- l,3-Propanediamine was tested in two independent experiments.
In the first cytogenetic assay, substance was tested up to 925 µg/ml for a 3 hour exposure time with a 24 hour fixation time in the absence of S9-fraction. In the presence of 1.8% (vlv) S9-fraction, was tested up to 1015 µg/ml for a 3 hour exposure time with a 24 hour fixation time. Appropriate toxicity was reached at these dose levels.
In the second cytogenetic assay, the substance was tested up to 850 µg/rnl for a 24 hour continuous exposure time with a 24 hour fixation time and up to 800 µg/ml for a 48 hour continuous exposure time with a 48 hour fixation time in the absence of S9-mix. In
the presence of S9-mix the substance was tested up to 1080 µg/ml for a 3 hour exposure time with a 48 hour fixation time. Appropriate toxicity was reached at these dose levels.
Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
Finally, it is concluded that this test is valid and that N-(2-[2-(Dimethylamine)Ethoxy]Ethyl}-N-Methyl-1,3-Propanediamine is not clastogenic in human lymphocytes under the experimental conditions described in this report. N- (2-[2-(Dimethylamine)Ethoxy]Ethyl ) -N-Methyl- l,3-Propanediamine may have the potential to disturb mitotic processes and cell cycle progression.
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