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EC number: 218-059-8 | CAS number: 2044-64-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2005
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N-dimethyl-3-oxobutyramide
- EC Number:
- 218-059-8
- EC Name:
- N,N-dimethyl-3-oxobutyramide
- Cas Number:
- 2044-64-6
- Molecular formula:
- C6H11NO2
- IUPAC Name:
- N,N-dimethyl-3-oxobutyramide
- Reference substance name:
- N,N-Dimethylacetoacetamide
- IUPAC Name:
- N,N-Dimethylacetoacetamide
- Test material form:
- other: yellow liquid
- Details on test material:
- Test item name: N,N-Dimethylacetoacetamide
Constituent 1
Constituent 2
Method
- Target gene:
- Evaluation of the test substance for its ability to induce reverse mutations either in the presence or absence of an exogenous S9 metabolic
activation system at the histidine locus in the genome of Salmonella typhimurium (strains TA98, TA100, TA1535, and TA1537),
and at the tryptophan locus of the Escherichia coli strain WP2 uvrA.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1537
- 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:
- Aroclor 1254-induced rat liver S9 from male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- 33.3, 66.7, 100, 333, 667, 1000, 3333 and 5000 µg per plate
- Vehicle / solvent:
- HPLC-grade sterile water
Controls
- Untreated negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Negative solvent / vehicle controls:
- yes
- Remarks:
- HPLC-grade sterile water
- True negative controls:
- no
- Remarks:
- Concurrent solvent control only
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: acridine mutagen ICR-191, 2-aminoanthracene
- Details on test system and experimental conditions:
- Test Solution:
------------
The positive controls were dissolved in dimethyl sulfoxide (DMSO, CAS# 67-68-6, 99.9% purity, EMD), except for the test item, sodium azide and ICR-191, which were dissolved in sterile water.
Preparation of the Metabolic Activation System:
------------------------------------------
Liver homogenate (S9, average protein concentration: 37.8 ± 1.0 mg/mL) prepared from male Sprague-Dawley rats induced with Aroclor 1254
was purchased commercially (Moltox Inc., Boone, North Carolina).
The S9 was thawed and the 10% S9 mix prepared immediately prior to its use. The S9 mix was held on ice at all times.
Preparation and Storage of Tester Strain:
------------------------------------
Frozen permanent stocks of all tester strains were prepared by growing fresh overnight cultures with the addition of 0.09 mL DMSO per
milliliter of culture. Aliquots were frozen in dry ice and stored at ≤-70°C.
Master plates were prepared by streaking each tester strain from a frozen permanent stock onto either nutrient agar plates or minimal
glucose agar plates. The minimal glucose agar plates were supplemented with either histidine and biotin or tryptophan, and for strains
containing the pKM101 plasmid, ampicillin. Tester strain master plates were stored at 5 ± 3°C and assigned a one-month expiration date.
Overnight cultures for use in the study were inoculated from the appropriate master plates. Cultures were placed in a shaker/incubator for
overnight at 150 ± 50 rpm and 37 ± 2°C. To ensure that appropriate numbers of bacteria are plated, the length of incubation was determined
by spectrophotometric monitoring of culture density. Cultures were harvested when the tester strain culture titers were equal to or greater
than 0.3 x 109 cells per milliliter. - Evaluation criteria:
- Evaluation:
----------
Criteria for a positive response:
1. Strains TA1535 and TA1537
Data will be judged positive if the increase in mean revertants at the highest numerical dose response is ≥ 3.0-fold the mean concurrent negative
control value (vehicle control). This increase in the mean number of revertants per plate must be accompanied by a dose response
associated with increasing concentrations of the test substance.
2. Strains TA98, TA100 and WP2uvrA
Data sets will be judged positive if the increase in mean revertants at the highest numerical dose response is ≥ 2.0-fold the mean concurrent
negative control value (vehicle control). This increase in the mean number of revertants per plate must be accompanied by a dose response to
increasing concentrations of the test substance.
I. Data Presentation
Individual plate counts for all treated, positive and negative controls, and an evaluation of the bacterial background lawn are reported.
For each tester strain, the mean of the number of revertants and the standard deviations were calculated. - Statistics:
- An analytical verification of the test substance concentrations was not conducted.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity Test:
------------
No toxicity or test substance precipitate was observed at any dose level with any tester strain in the presence or absence of
S9 metabolic activation.
Any other information on results incl. tables
Sterility Controls:
No contaminant colonies were observed on the sterility plates for the most concentrated test substance dilution (50 mg/mL) and the S9 and sham mixes.
Solubility:
The test substance was soluble in water at 50 mg/mL, the highest concentration that was tested in the study.
Toxicity-Mutation Test:
In the toxicity-mutation test, the maximum dose evaluated was 5000 μg/plate. This dose was achieved using a concentration of 50 mg/mL and a 100 μL plating aliquot. The dose levels used in the test were 33.3, 66.7, 100, 333, 667, 1000, 3333, and 5000 μg/plate. No positive mutagenic responses were observed at any dose level in any tester strain in the presence or absence of S9 metabolic activation. No toxicity or test substance precipitate was observed at any dose level with any tester strain in the presence or absence of S9 metabolic activation.
Mutagenicity Test
Based on the toxicity-mutation test, the maximum dose evaluated in the mutagenicity test was 5000 μg/plate for tester strains TA98, TA100, TA1535, TA1537, and WP2uvrA in the presence and absence of S9. This dose was achieved using a concentration of 50 mg/mL and a 100 μL plating aliquot. The dose levels used in the test were 333, 667, 1000, 3333, and 5000 μg/plate for all tester strains. No positive mutagenic responses were observed at any dose level or with any tester strain in either the presence or the absence of S9. No toxicity or test substance precipitate was observed at any dose level with any tester strain in either the presence or the absence of S9.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
All criteria for a valid study were met. Under the conditions of this study, DMAA showed no evidence of mutagenicity in the Bacterial Reverse
Mutation Test either in the presence or absence of Aroclor-induced rat liver S9. The test substance was concluded to be negative in this
study. - Executive summary:
A study according to OECD Guideline 471 (Bacterial Reverse Mutation Assay), EU Method B.13/14 and EPA OPPTS 870.5100 was carried out in year 2005. Under the conditions of this study, DMAA showed no evidence of mutagenicity in the Bacterial Reverse Mutation Test either in the presence or absence of Aroclor-induced rat liver S9. The test substance was concluded to be negative in this study.
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