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EC number: 269-923-6 | CAS number: 68391-04-8 This substance is identified by SDA Substance Name: C12-C18 alkyl dimethyl amine and SDA Reporting Number: 16-040-00.
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 13 SEP 2006 to 27 NOV 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 473)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Amines, C12-18-alkyldimethyl
- EC Number:
- 269-923-6
- EC Name:
- Amines, C12-18-alkyldimethyl
- Cas Number:
- 68391-04-8
- Molecular formula:
- R-N(Me)2, whereas R= C12-18-alkyl (even numbered, unbranched, saturated)
- IUPAC Name:
- N,N-dimethyl-C12-18-(even numbered)-alkyl-1-amines
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 extract from phenobarbital/ß-naphthoflavone induced Wistar rats
- Test concentrations with justification for top dose:
- Pre-Test: 2.0, 3.9, 7.8, 15.6, 31.3, 62.5, 125.0 and 250.0 µg/mL
Experiment I:
Without S9 mix: 0.2, 0.5, 1.0, 2.0, 3.9, 7.8, 15.6 and 31.3µg/mL
With S9 mix: 0.5, 1.0, 2.0, 3.9, 7.8, 15.6, 31.3 and 62.5 µg/mL
Experiment II:
Without S9 mix: 0.2, 0.5, 1.0, 2.0, 3.9, 7.8, 15.6 and 31.3 µg/mL
With S9 mix: 1.0, 2.0, 3.9, 7.8, 15.6, 31.3, 62.5 and 125.0 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility properties and low toxicity to cell cultures
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- Two independent experiments were performed:
Experiment 1 with an exposure duration of 4 h without and with metabolic activation and chromosome preparation 18 h after start of treatment
Experiment 2 with an exposure duration of 18 and 28 h (each without metabolic activation) and chromosome preparation 18 h and 28 h after start of treatment, respectively as well as an exposure duration of 4 h (with metabolic activation) and chromosome preparation at 28 h after start of treatment. Two parallel cultures were analysed per group.
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: without S9: 4, 18 and 28 h; with S9: 4 h
- Fixation time (start of exposure up to fixation or harvest of cells): without S9: 18 and 28 h; with S9: 18 and 28 h
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): GIEMSA
NUMBER OF CELLS EVALUATED: 100 metaphase cells per slide (200 per dose from two independent cultures)
DETERMINATION OF CYTOTOXICITY
Method: mitotic index; cell numbers
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A test item is classified as non-clastogenic if:
-the number of induced structural chromosome aberrations in all evaluated dose groups is in the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps). and/or
-no significant increase of the number of structural chromosome aberrations is-observed.
A test item is classified as clastogenic if:
-the number of induced structural chromosome aberrations is not in the range of our historical control data (0.0 - 4.0 % aberrant cells, exclusive gaps).
and
-either a concentration-related or a significant increase of the number of structural chromosome aberrations is observed.
However, both biological and statistical significance should be considered together. If the criteria mentioned above for the test item are not clearly met, the classification with regard to the historical data and the biological relevance is discussed and/or a confirmatory experiment is performed.
Although the inclusion of the structural chromosome aberrations is the purpose of this study, it is important to include the polyploids and endoreduplications. The following criteria is valid:
A test item can be classified as aneugenic if:
-the number of induced numerical aberrations is not in the range of our historical control
data (0.0 - 5.2.% polyploid cells). - Statistics:
- Statistical significance was confirmed by means of the Fisher's exact test (p < 0.05).
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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no influence
- Effects of osmolality: no influence
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: observed at concentrations >=7.8 µg/mL (with S9, Exp I and II)
RANGE-FINDING/SCREENING STUDIES: Concentrations between 2.0 and 250.0 µg/mL were applied. Clear toxic effects were observed after treatment with 15.6 µg/mL and above in the absence of S9 mix and with 31.3 µg/mL and above in the presence of S9 mix. In addition, 24 hrs continuous treatment with 2.0 µg/mL and above in the absence of S9 mix induced strong toxic effects
COMPARISON WITH HISTORICAL CONTROL DATA:
Results were within the range of historical control values - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
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
- Conclusions:
- In the two independent performed experiments, no clastogenic effects were observed in the presence and absence of metabolic activation
In both experiments, precipitation of the test item in culture medium was observed with 15.6µg/mL and above in the absence of S9 mix with 7.8µg/mL and above in the presence of S9 mix. - Executive summary:
The test item dissolved in ethanol, was assessed for its potential to induce structural chromosome aberrations in V79 cells of chinese hamster in vitro in two independent experiments. In each experimental group two parallel cultures were set up. Per culture at least 100 metaphase plates were scored for structural chromosome aberration interval without metabolic activation, where only 50 metaphase plates were scored. The highest applied concentration in the pre-test on toxicity (250 µg/mL) was chosen with regards to the evaluationof cytotoxicity. Dose selection for the cytogenetic experiments was performed considering the toxicity data and the occurrence of precipitation.
No clastogenicity was observed, either with or without metabolic activation, at the concentrations evaluated. A single statistically significant increase of 4.0 % in the number of aberrant cells, excluding gaps was observed in the presence of S9 mix after 4 hrs treatment with the preparation interval of 18 hrs. However, this value was within the range of the historical control data (0.0 -4.0% aberrant cells excluding gaps) and has to be regarded as biologically irrelevant. Moreover, in the repeat experiment with the preparation interval 28 hrs, no increase in the number of aberrant cells was observed at the identical or higuer concentration.
No relevant increase inthe frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls.
Appropriate mutagens were used as positive controls. They included statistically significant increases (p<0.05) in cells with structural chromosome aberrrations.
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