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Diss Factsheets
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EC number: 944-968-0 | CAS number: -
- 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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to guideline, well conducted (GLP) and documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 67359-57-3
- 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-Dimethydecan-1-amide and N,N-Dimethyloctan-1-amide
- Physical state: liquid
- Storage condition of test material: roomtemperature
Constituent 1
Constituent 2
Method
- Target gene:
- HGPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- V79 cell line was originally derived from the lung of a
male Chinese hamster (Chu and Mailing, 1968) kind gift from Prof. G. Speit, University of Ulm, Germany
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix Aroclor 1254 induced from Wistar rats
- Test concentrations with justification for top dose:
- Cytotoxicity test: 7.9, 15.7, 31.3, 62.5, 125.0, 250.0, 500.0, 750.0, 1000.0 µg/ml
Main test: 25.0, 50.0, 100.0, 125.0, 150.0, 200.0, 250.0µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Ethylmethanesulfonate (EMS) and Dimethylbenzanthracene (DMBA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium (containing 2% FCS)
according to Guideline
DURATION
- Preincubation period: 16-24h
- Exposure duration: 5h
- expression period: 6 days
- Selection time (if incubation with a selection agent): 7 days
SELECTION AGENT (mutation assays): 6-Thioguanine
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: triplicates for cytotoxicity
Main test (repeated completly two times ): 8 dishes (from 1 flask) were examined, for each dosage 2 flask were used.
NUMBER OF CELLS EVALUATED:
for each dose level one flask with 4*10e6 cells were avaiable.
DETERMINATION OF CYTOTOXICITY
- Method: cell count, average count, cytotoxicity was expressed by comparison of
colonies in treated cultures versus vehicle control cultures (relative cloning efficiency)
- Evaluation criteria:
- The number of 6-TG resistant colonies in the mutation assay dishes and the number of colonies in the
cloning efficiency dishes were determined.Colonies with 50 cells or less were excluded - Statistics:
- Weighted analysis of variance as well as to a weighted recursive regression, both with Poisson derived weights. Weighted analysis of
variance followed by pairwise comparisons using Dunnetts test.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to cytotoxic concentration
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test article after addition of the test article-Ethanol solution to
the medium starting to be evident at 1500 µg/ml. Therefore, a preliminary cytotoxicity test was conducted with a series of
9 concentrations ranging from 7.9 µg/ml to 1000 µg/ml - 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
the test article is considered to be nonmutagenic in the V79-HGPRT Forward Mutation Assay both with and without metabolic activation. - Executive summary:
The test material, confidential substance name, was assayed for mutagenic activity at the HGPRT locus in V79 cells from 25 to 250 µg/ml both, with and without metabolic activation according to OECD guideline 476. Under both treatment conditions, cytotoxic effects were induced . The vehicle control mutant frequencies were all in the normal range of background frequencies for the assay. In contrast, the positive controls EMS and DMBA induced a distinct mutagenic effect in mutant frequency, which was significantly increased over the negative controls demonstrating the sensitivity of the test system and the ability to detect known mutagens.
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