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EC number: 216-700-6 | CAS number: 1643-20-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- March 4 2010 - May 12-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed to GLP
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:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides
- EC Number:
- 931-292-6
- Molecular formula:
- CnH(2n+3)NO, where n=14/16
- IUPAC Name:
- Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides
- Details on test material:
- - Name of test material (as cited in study report): Amin, C10-16-alkyldimethyl, N-oxide (AO-1270)
- Physical state: liquid
- Analytical purity: 28-30 %w/w based on AO content
- Composition of test material, percentage of components: Amineoxide 28.00 – 30.00 %; Amine <0.100 %; Water 70 – 72 %; Hydrogen peroxide 0.02 %
- Lot/batch No.: SWF-2061-041
- Stability under test conditions: stable
- Storage condition of test material: At a dry, cool place
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- The preparation of the Aroclor 1254 -induced rat S9 fraction was carried out according to MARON & AMES.
- Test concentrations with justification for top dose:
- Main study
Five concentrations ranging from 0.313 to 5.0 or 0.625 to 10.0 µg Amine, C10-16-alkyldimethyl, N-oxide (AO-1270)/mL were selected for the experiments without and with metabolic activation, respectively. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: aqua ad iniectibilia
- Justification for choice of solvent/vehicle: substance is soluble in water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua ad iniectabilia
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- aqua ad iniectabilia
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
Experiment 1: 4 hr with or without S9
Experiment 2: 4 hr with S9, 24 hr without S9
- Expression time (cells in growth medium): 8 days
SELECTION AGENT (mutation assays): 6-thioguanine
NUMBER OF REPLICATIONS: 5
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: relative plating efficiency - Evaluation criteria:
- If in both independent experiments solvent and positive controls show results within the norm and if the test item does not increase the mutation frequency 2-fold above the mean of the solvent controls under any condition, or if the mutation frequency is always lower than 40 x 10-6 and if at least 1000000 cells per condition have been evaluated, the item is considered as negative in the test.
In case of a dose-dependent increase of the mutation frequency in both independent experiments (at similar concentrations) to at least 2-fold solvent control and at least 40 x 10-6 both in the presence and/or absence of S9 mix, the item is considered as positive in the test.
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
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none noted
- Effects of osmolality: none noted
- Evaporation from medium: not applicable
- Water solubility: completely soluble in water
- Precipitation: none noted
- Other confounding effects:
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity in form of decreased plating efficiency (PE1) and (PE2) was noted in both experiments each carried out without and with metabolic activation at the top concentrations of 5.0 or 10.0 µg Amin, C10-16-alkyldimethyl, N-oxide (AO-1270)/mL medium, respectively. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mutagenicity
Experiments without metabolic activation (4-h or 24-h exposure)
The mutation frequency of the negative controlaqua ad iniectabiliawas 6.67 and 5.10 x 10-6 clonable cells. Hence, the negative controls were well within the expected range (see below).
The mutation frequency of the cultures treated with concentrations of 0.313, 0.625, 1.25, 2.5 or 5.0 µg Amin, C10-16-alkyldimethyl, N-oxide (AO-1270)/mL culture medium ranged from 1.21 to 7.10 x 10-6 clonable cells. These results are within the normal range of the negative controls.
Experiments with metabolic activation (4-h exposure)
The mutation frequency of the negative controlaqua ad iniectabiliawas 5.94 and 2.05 x 10-6clonable cells. Hence, the negative controls were well within the expected range (see below).
The mutation frequency of the cultures treated with concentrations of 0.625, 1.25, 2.5, 5.0 or 10.0 µg Amin, C10-16-alkyldimethyl, N-oxide (AO-1270)/mL culture medium ranged from 0.53 to 7.42 x 10-6 clonable cells. These results are within the normal range of the negative controls.
The positive controls EMS (ethyl methanesulfonate) in the direct test and DMBA (9,10-dimethyl-1,2-benzanthracene) a compound which requires metabolic activation caused a pronounced increase in the mutation frequencies ranging from250.98to1038.82x 10-6 clonable cells in the case of EMS and ranging from66.48to193.85x 10-6 clonable cells in the case of DMBA, indicating the validity of this test system.
The background mutation frequency at LPT ranges from 1.30 to 38.36 x 10-6clonable cells for the negative controls. The mutation frequency of the positive controls at LPT ranges from 112.1 to 1708.4 x 10-6clonable cells forand 130.0 to 2693.3 x 106clonable cells for DMBA.
No relevant change in pH value or osmolality was noted.
Tables of results are attached.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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