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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Reliable data from several guideline studies on in-vitro gene-mutation in bacterial cells are available for C10-DMA, C12-DMA, C12-14-DMA, C14-DMA, C16-DMA, C12-18 DMA and C18-DMA. Four reliable in-vitro cytogenetic studies in mammalian cells are available for C10-DMA, C16-DMA, C12-18 DMA and for C18-DMA. In addition, six in-vitro gene mutation studies in mammalian cells are available for the substances C10-DMA, C12-14-DMA, C16-DMA, C12-18 DMA and C18-DMA (all studies are reliable). Further one reliable in vivo cytogenetic study according to OECD TG 474 is available for C12-14-DMA. All studies demonstrate a lack of genotoxic activity of DMAs. Therefore, no classification according to Regulation (EC) No. 1272/2008 is warranted.
Link to relevant study records
- 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.
- Type of assay:
- in vitro mammalian chromosome aberration test
- 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
- 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.
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- 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.
- Type of assay:
- bacterial reverse mutation assay
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- experiment I and II
- 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
- Remarks:
- experiment I and II
- 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
- Remarks:
- experiment I and II
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- experiment I and II
- 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
- Remarks:
- experiment I and II
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Results presented above were obtained with the source substance C12-18-DMA.
- Executive summary:
The study used as source investigated the in vitro gene mutation potential of C12-18-DMA in bacteria. 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.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- 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.
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp I: >= 6 µg/mL without and at 32.0 µg/mL with metabolic activation, Exp II: at 6.ß µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Executive summary:
The study used as source investigated the in vitro gene mutation potential of C12-18 DMA in mammalian cells. 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.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- 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.
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp I: at conc. >= 8.0 µg/mL (without metabolic activation) and 16 µg/mL (with metabolic act.) Exp II: >= 4 µg/ml (without metabolic act.) and >=16 µg/mL with metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Executive summary:
The study used as source investigated the in vitro gene mutation potential of C12-18 DMA in mammalian cells. 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.
Referenceopen allclose all
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.
Results presented above were obtained with the source substance C12-18 DMA.
Additional results for C12-18 DMA:
relative | relative | mutant | relative | relative | mutant | |||||
conc. | S9 | cloning | cloning | colonies | induction | cloning | cloning | colonies/ | induction | |
per mL | mix | efficiency 1 | efficiency I | 10 6 cells | factor | efficiency I | efficiency II | 106cells | factor | |
% | % | % | % | |||||||
Column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
Experiment I / 4 h treatment | Culture I | culture II | ||||||||
Solvent control with ethanol | - | 100 | 100 | 15,9 | 100 | 100 | 14,4 | |||
Positivw control with EMS | - | 100 | 100 | 10,1 | 1 | 100 | 100 | 24,5 | 1 | |
Test item | 150 | - | 79,1 | 71,4 | 162,9 | 10,2 | 88,1 | 107,8 | 118,6 | 8,2 |
Test item | 0,5 | - | 97 | culture was not continued # | 99,8 | culture was not continued # | ||||
Test item | 1 | - | 107,7 | culture was not continued # | culture was not continued # | |||||
Test item | 2 | - | 102,7 | 93,9 | 11,8 | 1,2 | 91 | 104,2 | 8,5 | 0,3 |
Test item | 4 | - | 32,8 | 59,1 | 7,8 | 0,8 | 85,4 | 105,6 | 10,5 | 0,4 |
Test item | 6 | - | 18,3 | 88,9 | 11,5 | 1,1 | 43,9 | 102,8 | 3,1 | 0,1 |
Test item | 8 | - | 14,2 | 83,1 | 6,4 | 0,6 | 7,4 | 97,7 | 19,7 | 0,8 |
Test item | 12 | - | 12,9 | 85,6 | 10,5 | 1 | 4,3 | 90,1 | 3,9 | 0,2 |
Test item | 16 | - | 0 | culture was not continued ## | 0 | culture was not continued ## | ||||
Neg.control | + | 100 | 100 | 8,5 | 100 | 100 | 4,2 | |||
Solv.control with ethanol | + | 87,8 | 100 | 13 | 1 | 100 | 100 | 2,6 | 1 | |
Pos. Control with DMBA | 2 | + | 26,2 | 58,9 | 1058,9 | 125 | 43,1 | 45,5 | 1217,6 | 289,2 |
Test item | 2 | + | 90 | 97,2 | 5,6 | 0,4 | 88,5 | 89,3 | 8,3 | 3,2 |
Test item | 4 | + | 89,8 | 93 | 12,7 | 1 | 101,4 | 87,1 | 5,9 | 2,2 |
Test item | 8 | + | 77,5 | 93 | 8,1 | 0,6 | 97,9 | 92,2 | 5,1 | 2 |
Test item | 16 | + | 82,7 | 94,5 | 10,2 | 0,8 | 65,1 | 64,3 | 8,2 | 3,1 |
Test item | 32 | + | 11,3 | 99,2 | 10,6 | 0,8 | 12,1 | 81 | 15,8 | 6 |
Test item | 48 | + | 0 | culture was not continued## | 0 | culture was not continued## | ||||
Experiment II / 24 h treatment | culture I | culture II | ||||||||
Negative control | - | 100 | 100 | 6,2 | 100 | 100 | 5,2 | |||
Solv. Control with ethanol | - | 100 | 100 | 10,4 | 1 | 100 | 100 | 5,7 | 1 | |
Pos.control with EMS | 75 | - | 80 | 90 | 198,3 | 31,8 | 88,1 | 97,1 | 152,6 | 29,9 |
Test item | 0,5 | - | 77,4 | 96,8 | 9,1 | 0,9 | 94,1 | 97,6 | 6,8 | 1,2 |
Test item | 1 | - | 81,5 | 107,3 | 7,7 | 0,7 | 97,1 | 77,2 | 4,9 | 0,9 |
Test item | 2 | - | 68,9 | 112,6 | 4,2 | 0,4 | 95,9 | 86,4 | 5,6 | 1 |
Test item | 4 | - | 49,7 | 91,5 | 3,9 | 0,4 | 82,3 | 75,9 | 6,6 | 1,2 |
Test item | 6 | - | 4 | 78 | 5,3 | 0,5 | 0 | 63,3 | 14,8 | 2,6 |
Test item | 8 | - | culture was not continued## | culture was not continued## | ||||||
Test item | 12 | - | culture was not continued## | culture was not continued## | ||||||
Test item | 16 | - | culture was not continued## | culture was not continued## |
Results presented above were obtained with the source substance C12-18 DMA.
Additional results for C12-18 DMA:
relative | relative | mutant | relative | relative | mutant | |||||
conc. | S9 | cloning | total | colonies | induction | cloning | total | colonies/ | induction | |
µg/mL | mix | efficiency 1 | growth | 106cells | factor | efficiency | growth | 106cells | factor | |
Column | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
Experiment I / 4 h treatment | Culture I | culture II | ||||||||
Neg. Control with medium | - | 100 | 100 | 112 | 100 | 100 | 97 | |||
Pos. Control with MMS | 19,5 | - | 100 | 100 | 126 | 1 | 100 | 100 | 129 | 1 |
Test item | 0,5 | - | 67,8 | 32 | 368 | 3,3 | 41 | 25,8 | 411 | 3,2 |
Test item | 1 | - | 87 | 130 | 154 | 1,2 | 115,4 | 99,8 | 131 | 1 |
Test item | 2 | - | 100 | 114,9 | 84 | 0,7 | 109,9 | 77,9 | 98 | 0,8 |
Test item | 4 | - | 90,3 | 117,6 | 65 | 0,5 | 106,4 | 73,8 | 119 | 0,9 |
90,3 | 87,3 | 130 | 1 | 37,2 | 54 | 115 | 0,9 | |||
Test item | 8 | - | 19 | 70,6 | 164 | 1,3 | 10 | 58,7 | 166 | 1,3 |
Test item | 16 | - | 1,7 | culture was not continued# | 1,1 | culture was not continued# | ||||
Neg.contr.with medium | + | 100 | 100 | 116 | 100 | 100 | 98 | |||
Solv.control with ethanol | + | 100 | 100 | 100 | 1 | 100 | 100 | 79 | 1 | |
Pos. Control with CPA | 4,5 | + | 35,3 | 27,3 | 3,3 | 34,5 | 27,3 | |||
Test item | 0,5 | + | 116,9 | culture was not continued ## | 78,7 | culture was not continued ## | ||||
Test item | 1 | + | 131,6 | 87,5 | 204 | 2 | 100 | 63,6 | 170 | 2,1 |
Test item | 2 | + | 98,4 | 83,7 | 181 | 1,8 | 93 | 57,8 | 157 | 2 |
Test item | 4 | + | 82,9 | 99,4 | 124 | 1,2 | 75,1 | 70,4 | 108 | 1,4 |
Test item | 8 | + | 73,8 | 73,4 | 166 | 1,7 | 71,7 | 58 | 148 | 1,9 |
Test item | 16 | + | 64,9 | 40,2 | 152 | 1,5 | 48,6 | 45,6 | 144 | 1,8 |
Experiment II / 24 h treatment | - | culture I | culture II | |||||||
Neg.contr.with medium | - | 100 | 100 | 162 | 100 | 100 | 81 | |||
Solv.control with ethanol | - | 100 | 100 | 95 | 1 | 100 | 100 | 109 | 1 | |
Pos.control with MMs | 13 | - | 16,8 | 10,7 | 485 | 3 | 30,9 | 10,8 | 755 | 9,4 |
Test item | 0,5 | - | 82 | 78,1 | 100 | 1,1 | 100 | 89,5 | 118 | 1,1 |
Test item | 1 | - | 134,1 | 78,9 | 126 | 1,3 | 77,9 | 72,1 | 144 | 1,3 |
Test item | 2 | - | 84,4 | 69,2 | 156 | 1,6 | 79,4 | 57,7 | 193 | 1,8 |
Test item | 4 | - | 43,5 | 24,1 | 221 | 2,3 | 59,9 | 23,8 | 271 | 2,5 |
Test item | 8 | - | (5,9) | (1,7) | (129) | (1,4) | (8,2) | (2,9) | (191) | (1,8) |
Test item | 16 | - | 0 | culture was not continued # | 1,6 | culture was not continued # | ||||
Test item | 24 | - | 0 | culture was not continued # | 0 | culture was not continued # | ||||
Test item | 32 | - | 0 | culture was not continued # | 0 | culture was not continued # | ||||
Experiment II / 4 h treatment | culture I | culture II | ||||||||
Neg.contr.with medium | + | 100 | 100 | 152 | 100 | 100 | ||||
Solv.control with ethanol | + | 100 | 100 | 89 | 1 | 100 | 100 | |||
Pos. Control with CPA | 4,5 | + | 13,9 | 16,1 | 527 | 3,5 | 11,2 | 14,4 | ||
Test item | 2 | + | 83,3 | 65,7 | 128 | 1,4 | 82,7 | 155,8 | ||
Test item | 4 | + | 68,6 | 88,7 | 127 | 1,4 | 90,5 | 149,4 | ||
Test item | 8 | + | 105,6 | 70,9 | 118 | 1,3 | 71,3 | 126 | ||
Test item | 16 | + | 42,2 | 38,2 | 102 | 1,1 | 33,5 | 68,1 | ||
Test item | 24 | + | (5,1) | (1,1) | (1047) | (11,7) | 5,9 | 41 | ||
Test item | 32 | 1,2 | culture was not continued # | 0,2 | culture was not continued # | |||||
Experiment IIA / 24 h treatment | culture I | culture II |
Neg.contr.with medium - 100 100 57 1 100 100 83 Solv.control with ethanol - 100 100 36 100 100 53 1 Pos. Control with MMS 13 - 26,6 20,7 338 6 7,6 15,4 343 4,2 Test item 13 - 53,3 26,6 87 1,5 50,2 44,8 60 1,1 Test item 2 - 43,1 21,8 90 1,6 48,8 44,8 46 0,9 Test item 4 - 25,6 11,3 109 1,9 30,1 37,2 82 1,5 Test item 6 - 21,2 5 63 1,1 20,7 12,6 88 1,7 Test item 8 - (6,3) (1,4) (32) (0,6) (9,9) (3,3) (81) (1,5)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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.
- Type of assay:
- micronucleus assay
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- in the highest dose group: motor activity decreased, diarrhea, palpebral fissure narrow, movements uncoordinated, stupor, tonic convulsion, and prone position
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Executive summary:
The study used as source investigated in vivo cytogenicity of C12-14 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.
Reference
Results presented above were obtained with the source substance C12-14 DMA.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Eleven reliable in-vitro gene-mutation studies (reliability 1 or 2) in bacteria are available for C10-DMA, C12-DMA, C12-14-DMA, C14-DMA, C16-DMA, C12-18 DMA and C18-DMA. All studies were performed according to the OECD TG 471. The results of these studies are comparable, demonstrating no mutagenic potential of DMAs.
Four in-vitro cytogenetic studies in mammalian cells are available for C10-DMA, C16-DMA, C12-18 DMA and for C18 -DMA. In addition, six in-vitro gene mutation studies in mammalian cells are available for the substances C10-DMA, C12-14-DMA, C16-DMA, C12-18 DMA and C18-DMA. All of these studies were performed according to OECD Guideline 473 or 476 respectively and merit Klimisch rating of 1. No mutagenic/no clastogenic potential was found. Based on the results obtained is not expected that the chain length variation influences the genotoxicity of DMAs.
Further one reliable (reliability 1) in vivo cytogenetic study according to OECD TG 474 is available for C12-14-DMA, demonstrating lack of genotoxic activity of DMAs in vivo as well.
All in all, data on genotoxicity are consistent. In vitro as well as in vivo data showed no genotoxic potential for the members of this category.
No classification according to Regulation (EC) No. 1272/2008 is warranted to members of DMAs and no further testing is needed.
Justification for classification or non-classification
In a reliable set of bacterial mutation assays, gene mutation studies in mammalian cells, and in vitro cytogenicity tests and one in vivo mutagenicity test, the DMAs of this category did not exert mutagenic or clastogenic activity.
Based on the available data no classification for mutagenicity according to Regulation (EC) No. 1272/2008 is necessary.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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