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EC number: 269-665-4 | CAS number: 68308-74-7
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 December 2012 to 05 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to relevant test guidelines, with no deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- DMATO
- IUPAC Name:
- DMATO
- Reference substance name:
- Amides, tall-oil fatty, N,N-di-Me
- EC Number:
- 269-665-4
- EC Name:
- Amides, tall-oil fatty, N,N-di-Me
- Cas Number:
- 68308-74-7
- Molecular formula:
- not applicable for UVCB
- IUPAC Name:
- Amides, tall-oil fatty, N,N-di-Me
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): DMATO
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: 12J46399
- Expiration date of the lot/batch: October 2015
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine (his) and tryptophan (trp)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment II: 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- The vehicle was DMSO, chosen according to its solubility properties and its relative nontoxicity to the bacteria. The test material was formulated in DMSO on the day of the experiment.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- The strain cultures were stored as stock cultures in ampoules with nutrient broth +5% DMSO in liquid nitrogen. From the thawed ampoules of the strains 0.5 mL bacterial suspension was transferred into 250 mL Erlenmeyer flasks containing 20 mL nutrient medium. A solution of 20 µL ampicillin (25 µg/mL) was added to the strains TA 98 and TA 100. The nutrient medium contained per litre: 8 g nutrient broth and 5 g NaCl. The bacterial cultures were incubated in a shaking water bath for 4 hours at 37°C. The optical density of the bacteria was determined by absorption measurement and the obtained values indicated that the bacteria were harvested at the late exponential or early stationary phase (10E8-10E9 cells/mL).
A pre-experiment was conducted in all strains at 8 doses between 3 and 5000 µg/plate, according to the plate incorporation assay. The pre-experiment was reported as Experiment I since the following criteria were met: evaluable plates (>0 colonies) at five concentrations or more in all strains used. Minor toxic effects were noted so the second experiment was performed with 7 concentrations up to a maximum of 5000 µg/plate. Experiment II was performed as a pre-incubation assay. Test material concentrations and controls were tested in triplicate for each strain. The following materials were mixed in a test tube and poured onto selective agar plates: 100 µL test solution, solvent or positive control; 500 µL S9 mix or buffer; 100 µL bacterial suspension; 2000 µL overlay agar. In the pre-incubation assay 100 µL test solution, solvent or positive control, 500 µL S9 mix or buffer and 100 µL bacterial suspension were mixed in a test tubes and incubated at 37°C for 60 minutes. After pre-incubation 2.0 mL overlay agar (45°C) was added to each tube. The mixture was then poured onto minimal agar plates. After solidification the plates were incubated upside down for at 48 hours at 37°C in the dark.
Overlay agar for S. typhimurium strains contained 7 g Agar Agar, 6.0 g NaCl, 10.25 mg L-Histidine HCl H2O and 12.2 mg Biotin. Overlay agar for E. coli contained 7.0 g Agar Agar, 6.0 g NaCl and 10.2 mg Tryptophan. Sterilisations were performed at 121°C in an autoclave.
The colonies were counted using the Petri Viewer Mk2 with the software program Ames Study Manager. The counter was connected to an IBM AT compatible PC with printer which printed out both, the individual and mean values of the plates for each concentration together with standard deviations and enhancement factors as compared to the spontaneous reversion rates. Due to precipitation of the test item, the revertant colonies were partly counted manually. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
The assay was considered acceptable if it meets the following criteria: regular background growth in the negative and solvent control; the spontaneous reversion rates in the negative and solvent control are in the range of historical data; the positive control substances should produce a significant increase in mutant colony frequencies; a minimum of five analysable dose levels should be present with at least three dose levels showing no signs of toxic effects, evident as a reduction in the number of revertants below the indication factor of 0.5. - Statistics:
- Not required.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Minor toxic effects were observed only in the presence of metabolic activation in strains TA 1535 and TA 1537 in experiment I at 5000 µg/plate and in experiment II in strain TA 1535 at 1000 and 2500 µg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The test item precipitated in the overlay agar in the test tubes from 100 to 5000 µg/plate in both experiments. Precipitation of the test item in the overlay agar on the incubated agar plates was observed at 2500 and 5000 µg/plate without S9 mix in experiment I and from 1000 to 5000 µg/plates in experiment I with S9 mix and in experiment II with and without S9 mix. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments. No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation. Minor toxic effects were observed only in the presence of metabolic activation in strains TA 1535 and TA 1537 in experiment I at 5000 µg/plate and in experiment II in strain TA 1535 at 1000 and 2500 µg/plate.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with DMATO at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No further information.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
The test material did not induce gene mutations by base pair changes or frameshifts under the experimental conditions. DMATO is therefore considered to be non-mutagenic in the bacteria reverse mutation assay - Executive summary:
The potential for DMATO to induce gene mutation in the bacterial reverse mutation assay was evaluated in Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100, and in Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without metabolic activation (S9 mix). The following concentrations were tested in Experiment I (plate incorporation test): 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate. The following concentrations were tested in Experiment II (pre-incubation test): 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate. Appropriate negative, solvent and positive controls were tested. All test solution concentrations and controls were tested in triplicate. The plates incubated with the test material showed normal background growth up to 5000 µg/plate with and without metabolic activation in both experiments. No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation. Minor toxic effects were observed only in the presence of metabolic activation in strains TA 1535 and TA 1537 in Experiment I at 5000 µg/plate and in Experiment II in strain TA 1535 at 1000 and 2500 µg/plate. No substantial increase in revertant colony numbers of any of the five tester strains was observed at any dose level, in the presence or absence of metabolic activation. There was no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. The test material did not induce gene mutations by base pair changes or frameshifts under the experimental conditions. DMATO is therefore considered to be non-mutagenic in the bacteria reverse mutation assay
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