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EC number: 812-378-1 | CAS number: 210420-85-2
- 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 October 2016 - 02 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 210420-85-2
- Reference substance name:
- N-methyldidecylamine
- EC Number:
- 230-990-1
- EC Name:
- N-methyldidecylamine
- Cas Number:
- 7396-58-9
- Molecular formula:
- C21H45N
- IUPAC Name:
- N-decyl-N-methyldecan-1-amine
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Not available
- IUPAC Name:
- Unknown impurities
- Test material form:
- solid
- Details on test material:
- - Appearance: Slightly yellow gel
- Storage conditions: At room temperature; container flushed with nitrogen
Constituent 1
Constituent 2
Constituent 3
impurity 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment 1: Direct plate assay
Dose range finding test:
TA100 and WP2uvrA without and with S9: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate
Direct plate assay:
TA1535, TA1537, TA98 and TA100 without S9-mix: 0.052, 0.17, 0.51, 1.6, 5.0 and 16 µg/plate
TA1535, TA1537 and TA98 with S9-mix: 0.17, 0.51, 1.6, 5.0, 16 and 48 µg/plate
Experiment 2: Pre-incubation assay
Dose range finding test::
TA100 and WP2uvrA without S9-mix: 0.016, 0.052, 0.17, 0.51, 1.6, 5.0 and 16 µg/plate
TA100 and WP2uvrA with S9-mix: 0.052, 0.17, 0.51, 1.6, 5.0, 16 and 48 µg/plate
Pre-incubation assay:
TA100 and WP2uvrA without S9-mix: 0.016, 0.052, 0.17, 0.51, 1.6, 5.0 and 16 µg/plate.
TA100 and WP2uvrA with S9-mix: 0.052, 0.17, 0.51, 1.6, 5.0, 16 and 48 µg/plate.
TA1535, TA1537 and TA98 without S9-mix: 0.052, 0.17, 0.51, 1.6, 5.0 and 16 µg/plate.
TA1535, TA1537 and TA98 with S9-mix: 0.17, 0.51, 1.6, 5.0, 16 and 48 µg/plate. - Vehicle / solvent:
- - Vehicle used: Milli-Q water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9, 5 µg/plate in saline for TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191
- Remarks:
- without S9, 2.5 µg/plate in DMSO for TA1537 (direct plate)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene
- Remarks:
- without S9, 10 µg/plate in DMSO for TA98 and 15 µg/plate in DMSO for TA98 (pre-incubation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9, 650 µg/plate in DMSO for TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9, 10 µg/plate in DMSO for WP2uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9, in DMSO, 2.5 µg/plate for TA1535 and TA1537, 1 µg/plate for TA98 and TA100 (direct plate), 5 µg for TA100 (pre-incubation), 15 µg for WP2uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hour
- Pre-incubation period: 30 minutes (pre-incubation experiment only)
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Rationale for test conditions:
- Concentrations were chosen based on dose range finding study
- Evaluation criteria:
- Acceptability of the assay
The assay is considered acceptable if it meets the following criteria:
a) The vehicle control and positive control plates from each tester strain (with or without S9-mix) must exhibit a characteristic number of revertant colonies when compared against relevant historical control data generated at Charles River Den Bosch.
b) The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
c) No more than 5% of the plates are lost through contamination or some other unforeseen event. If the results are considered invalid due to contamination, the experiment will be repeated.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment. - Statistics:
- No formal hypothesis testing was done.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- up to precipitating concentrations (with S9-mix)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
Precipitation:
Direct plate assay: For WP2uvrA precipitation was observed at single dose levels of 17 and 52 µg/plate in the absence and presence of S9-mix, respectively.
Pre-incubation assay: Precipitation was observed in TA100 and WP2uvrA at concentrations of 5.0 µg/plate and upwards (absence of S9-mix) and 16 µg/plate and upwards (presence of S9-mix). Except in tester strain WP2uvrA,where no precipitation of the test item was observed at 16 µg/plate.
RANGE-FINDING/SCREENING STUDIES:
Direct plate assay:
- In tester strain TA100, only two analysable dose levels could be used for the evaluation of the results in the absence of S9-mix. Therefore, this part of the study was again tested in the first mutation experiment. In tester strain WP2uvrA, toxicity was observed at dose levels of 52 µg/plate and above in the absence and 164 µg/plate and above in the presence of S9-mix.
Pre-incubation assay:
- In tester strain TA100, toxicity was observed at dose levels of 5.0 µg/plate and above in the absence and 48 µg/plate and above in the presence of S9-mix. In tester strain WP2uvrA, toxicity was observed at dose levels at 16 µg/plate in the absence of S9-mix and no cytotoxicity up to 48 µg/plate in the presence of S9-mix (slight precipitate).
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Direct plate assay
TA1535: without S9: 16 µg/plate and above and with S9: 48 µg/plate and above
TA1537: without S9: 16 µg/plate and above and with S9: 16 µg/plate and above
TA98: without S9: 16 µg/plate and above and with S9: 48 µg/plate and above
TA100: without S9: 16 µg/plate and above and with S9: 52 µg/plate and above
WP2uvrA: without S9: 52 µg/plate and above and with S9: 164 µg/plate and above
pre-incubation assay
TA1535: without S9: 1.6 µg/plate and above and with S9: 16 µg/plate and above
TA1537: without S9: 1.6 µg/plate and above and with S9: 16 µg/plate and above
TA98: without S9: 5.0 µg/plate and above and with S9: 48 µg/plate and above
TA100: without S9: 1.6 µg/plate and above and with S9: 48 µg/plate and above
WP2uvrA: without S9: 16 µg/plate and above and with S9: no cytotoxicity (Slight precipitate)
Applicant's summary and conclusion
- Conclusions:
- In an AMES test, performed according to OECD 471 guideline and in accordance with GLP principles, 1-Decanaminium, N-decyl-N,N-dimethyl-, hexanedioate (2:1) was found not to be mutagenic with or without metabolic activation.
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