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EC number: 269-915-2 | CAS number: 68390-97-6 This substance is identified by SDA Substance Name: C16-C18 alkyl dimethyl amine and SDA Reporting Number: 19-040-00.
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint-specific justification, please see read-across justification document (category approach) in the linked category of dimethylalkylamines.
Data source
Materials and methods
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Amines, C16-18-alkyldimethyl
- EC Number:
- 269-915-2
- EC Name:
- Amines, C16-18-alkyldimethyl
- Cas Number:
- 68390-97-6
- Molecular formula:
- R-N(Me)2, whereas R= C16-18-alkyl (even numbered, unbranched, saturated)
- IUPAC Name:
- N,N-dimethyl-C16-18-(even numbered)-alkyl-1-amines
Constituent 1
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
- Remarks:
- Exp I: at concentrations of 15.6 and 31.3 µg/mL, Exp II: at all concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Results presented above were obtained with the source substance C12-18 DMA.
Additional results for C12-18 DMA:
Exp. | Preparation interval | Test item concentration in µg/mL | Polyploid cells in % | Cell numbers in % of control | Mitotic indices in % of control | incl.gaps* | Aberrant cells in % excl.gaps* | with exchanges |
Exposure period 4 hrs without S9 mix | ||||||||
I | 18 hrs | Solvent control1 | 2,7 | 100 | 100 | 2,5 | 2,5 | 0,5 |
Positive control2 | 3,1 | n.t | 100,8 | 12 | 10,55 | 6,5 | ||
2 | 2,9 | 56,9 | 97,5 | 3,5 | 3 | 1 | ||
3,9 | 4 | 69,5 | 93 | 3,5 | 2,5 | 0 | ||
7,8 | 2,5 | 62,7 | 84,4 | 2,5 | 2 | 0 | ||
Exposure period 18 hrs without S9 mix | ||||||||
II | 18 hrs | Solvent control1 | 2,3 | 100 | 100 | 1,5 | 1,5 | 0,5 |
Positive control3 | 2,8 | n.t | 100,8 | 9,5 | 9,55 | 6,5 | ||
1 | 3,1 | 104,4 | 97,5 | 1,5 | 1,5 | 1 | ||
2 | 3,1 | 64,2 | 93 | 1,5 | 1,5 | 0 | ||
3,9## | 3,2 | 28,3 | 84,4 | 2,8 | 2,5 | 0 | ||
Exposure period 28 hrs without S9 mix | ||||||||
II | 28 hrs | Solvent control1 | 1,2 | 100 | 100 | 2 | 2 | 0 |
Positive control3* | 2,8 | n.t | 67,1 | 49 | 49,05 | 18 | ||
1 | 3 | 72,1 | 101,9 | 2,5 | 2,5 | 0 | ||
2 | 4,4 | 37,7 | 70,6 | 3 | 2 | 0 |
*: Inclusive cells carrying exchanges
#: Evaluation of 50 metaphase plates per culture
##: Evaluation of 200 metaphase plates per culture
n.t: Not tested
P: Precipitation occurred
S: Aberration frequency statistically significant higher than corrresponding control values
1: Ethanol 0.5%(v/v)
2: EMS 900.0 µg/ml
3: EMS 500.0 µg/mL
Exp. | Preparation interval | Test item concentration in µg/mL | Polyploid cells in % | Cell numbers in % of control | Mitotic indices in % of control | incl.gaps* | Aberrant cells in % excl.gaps* | with exchanges |
Exposure period 4 hrs without S9 mix | ||||||||
I | 18 hrs | Solvent control1 | 3,5 | 100 | 100 | 1,5 | 1 | 0 |
Positive control2 | 3,1 | n.t | 59,6 | 10,5 | 10,55 | 2 | ||
3,9 | 2,4 | 82,4 | 121,1 | 1,5 | 1,5 | 0,5 | ||
7,8P | 3,4 | 96,9 | 137,8 | 3 | 2,5 | 0,5 | ||
15,6P | 3,3 | 62,1 | 128,9 | 6 | 4,05 | 0,5 | ||
Exposure period 28 hrs with S9 mix | ||||||||
II | 28 hrs | Solvent control1 | 1,7 | 100 | 100 | 2 | 1,5 | 0,5 |
Positive control3* | 1,6 | n.t | 101,4 | 12 | 11,5 s | 3,5 | ||
3,9 | 2,6 | 94,7 | 101,4 | 3 | 2,5 | 0,5 | ||
7,8P | 2,8 | 124,9 | 106,1 | 4,5 | 4 | 0,5 | ||
15,6P | 2,2 | 97,1 | 96,4 | 2,5 | 2 | 0,5 | ||
31,3P | 3 | 32,2 | 83,9 | 1,5 | 1 | 0 |
*: Inclusive cells carrying exchanges
n.t: not tested
P: Precipitation occurred
S: Aberration frequency statistically significant higuer than corrresponding control values
1: Ethanol 0.5 % (v/v)
2: CPA 1.4 µg/mL
3: CPA 2.0 µg/mL
without S9 mix | with S9 mix | ||||
Exp.I | Exp. II | Exp.I | Exp. II | ||
Exposure period | 4 hrs | 18 hrs | 28 hrs | 4 hrs | 4 hrs |
Recovery | 14 hrs | - | - | 14 hrs | 24 hrs |
Preparation interval | 18 hrs | 18 hrs | 28 hrs | 18 hrs | 28 hrs |
Exp. | Preparation interval | Exposure period | Concentration in µg/mL | |||
without S9 mix | ||||||
I | 18 hrs | 4 hrs | 2 | 3,9 | 7,8 | |
II | 18 hrs | 18 hrs | 1 | 2 | 3,9 | |
II | 28 hrs | 28 hrs | 1 | 2 | ||
with S9 mix | ||||||
I | 18 hrs | 4 hrs | 3,9 | 7,8P | 15,6P | |
II | 28 hrs | 4 hrs | 3,9 | 7,8P | 15,6P | 31,3P |
P: precipitation occurrred
In the absence of S9 mix, 4 hrs exposure resulted in the cell number reduction to 62.7% of control at 7.8 µg/mL. Evaluation of cytogenetic damage at the next higher concentration of 15.6µg/mL was not possible due to the observed high cytotoxicity, the cell number reduction being 3.9% of control. In the experiments with treatment periods of 18 and 28 hrs, evaluation of cytogenetic damage was performed up to the concentrations inducing a cell number reduction to 28.3 and 37.7% of control, respectively.
In the first experiment, in the presence of S9 mix, after 4 hrs exposure with 15.6µg/mL at the 18 hrs preparation interval resulted in a cell number reduction to 62.1% of control. Evaluation of cytogenetic damage at the next higher concentration of 31.3µg/mL was not possible due to the observed high cytotoxicity, the cell number reduction being 3.5% of damage was performed up to the concentration inducing cell number reduction to 32.2 of control.
Applicant's summary and conclusion
- Executive summary:
The study used as source investigated the in vitro gene cytogenicity of C12-18 DMA. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in the linked category of dimethylalkylamines.
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