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EC number: 806-919-0 | CAS number: 1356964-77-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to guideline, well conducted (GLP) and documented. Reliability reduced due to read-across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 67359-57-3
- EC Number:
- 614-052-2
- Cas Number:
- 67359-57-3
- IUPAC Name:
- 67359-57-3
- Reference substance name:
- N,N-Dimethyldecan-1-amide, mixture with N,N-Dimethyloctanc-1-amide
- IUPAC Name:
- N,N-Dimethyldecan-1-amide, mixture with N,N-Dimethyloctanc-1-amide
- Details on test material:
- - Chemical name: mixture of N,N-dimethylcapramide (N,N-Dimethydecan-1-amide) and
N,N-dimethylcaprylamide (N,N-Dimethyloctan-1-amide)
- Physical state: liquid
- Storage condition of test material: roomtemperature
Constituent 1
Constituent 2
Method
- Target gene:
- in vitro cytogenetic test
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix from Aroclor 1254 treated wistar rats
- Test concentrations with justification for top dose:
- 0, 10, 40, 160 µg/ml (without S9)
0, 7.2, 36, 180 µg/ml (with S9)
with harvest time 24h
highest concentration again additional with harvest time 8h and 30 h tested
Pretest with concentration up to 1000 µg/ml showed less survived cells in concentration of 160 µg/ml and above - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (stock solution containing 500mg/ml in ethanol was diluted in culture medium up to a concentration of 1mg/ml
- Justification for choice of solvent/vehicle: solubility
Controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- untreated control
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C and cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4h at 37°C
- Fixation time (start of exposure up to fixation or harvest of cells): 8, 24h (main study), 30h
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): 5% Giemsa solution
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: 1 x 10e6 cells were seeded in 20ml medium (containing 0.2ml testitem in solvent, and 1mL S9 mix if metabolic activation)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index and cell survival
- Evaluation criteria:
- The mitotic index was determined by counting 1000 cells per culture.
Chromosomes of approximately 200 metaphases per concentration, 100 metaphases from each of two parallel cultures, were
examined for structural changes.
classes of aberrations are characterized as follows:
Gaps
Break
Fragment
Deletion
Exchange
Multiple abberation - Statistics:
- The statistical analysis of the results was performed by pair-wise comparison of the numbers of
metaphases with aberrations (including and excluding gaps) and of metaphases with exchanges among 200 cells for treatment
and solvent control groups.
The statistical analysis followed the recommendations outlined by Richardson et al. (1989)
Fisher exact test was used for the statistical evaluation.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- tested up to first cytotoxic concentration 160µg/ml 180µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: 2 pre studies - first pre study ranging from 10 to 1000µg/ml
- secound pre study ranging from 100 to 250 µg/ml
COMPARISON WITH HISTORICAL CONTROL DATA: historical control data were added to the study report.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Survival index determined, highest tested concentration reduces the index by a minimum of 40% (43.2 ; 160µg/ml without S9 and 66.7%; 180µg/ml with S9) harvest time of 8 h, only moderate to negligible effects (with no effects) were seen for harvest times of 24h and 30h - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Not considered to be clastogenic for mammalian cells with and without metabolic activation - Executive summary:
Chinese hamster ovary cells were treated with confidential substance name at the concentrations of 10, 40 and 160 µg/ml medium without S9 mix and at the concentrations of 7.2, 36 and 180 µg/ml with S9 mix. Confidential substance name induced cytotoxic effects in cells exposed to the highest doses with and without metabolic activation at the early harvest time of 8 hours after the beginning of the treatment. The mitotic indices were markedly reduced to 66.7 and 43.2 % relative to control cells.
With one exception, no statistically significant or biologically relevant increases of numbers of metaphases with aberrations were detected 8, 24 or 30 hours after the beginning of the four hour treatment with the test substance with and without S9 mix (Tables 2-5). A statistically significant increase of the numbers of cells with aberrations was calculated for cells exposed to the dose of 180 µg/ml with metabolic activation and the harvest time of 8 hours. However, the absolute number of cells with aberrations (3.5 %) was within the normal range as compared to the values for other solvent controls within this study and for other studies performed in this laboratory. This statistically significant increase was therefore considered to be caused by the unusually low number of cells with aberrations in the corresponding solvent control. This statistically significant result is therefore considered not to be biologically relevant.
The positive controls mitomycin C and cyclophosphamide induced clear clastogenic effects and demonstrated the sensitivity of the test system.
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