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EC number: 227-372-9 | CAS number: 5810-11-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-chloro-N,N-dimethyl-3-oxobutyramide
- EC Number:
- 227-372-9
- EC Name:
- 2-chloro-N,N-dimethyl-3-oxobutyramide
- Cas Number:
- 5810-11-7
- Molecular formula:
- C6H10ClNO2
- IUPAC Name:
- 2-chloro-N,N-dimethyl-3-oxobutanamide
- Reference substance name:
- Butanamide, 2-chloro-N,N-dimethyl-3-oxo
- IUPAC Name:
- Butanamide, 2-chloro-N,N-dimethyl-3-oxo
- Details on test material:
- Name:DIMETHYL-2-CHLORACETOACETAMID
Batch No.: not indicated
CAS No.: 005810-11-7
Aggregate State at RT: liquid
Colour: brown
Analysis: not indicated by the sponsor
Stability: Pure: stable
Storage: 20 0 C, light protected the test article was stored at 40 C
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Experiment 1: TA98 and TA 100: 33.3; 100.0; 333.3; 1000.0; 2500.0; 5000.0 µg/plate
Experiment 1: TA 1535, TA 1537, TA 102: 10.0; 33.3; 100.0; 333.3; 666.6; 1000.0 µg/plate
Experiment 2, all strains: 10.0; 33.3; 100.0; 333.3; 666.6; 1000.0 µg/plate - Vehicle / solvent:
- water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- for TA1535, TA 100, without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Remarks:
- for TA98, TA 1537, without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- for TA102, without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2-AA
- Remarks:
- all strains with metabolic activation
- Details on test system and experimental conditions:
- Pre-Experiment for Toxicity
To evaluate the toxicity of the test article a pre-experiment was performed with strains TA 98 and TA 100. Eight concentrations were tested for toxicity and mutation induction with each 3 plates. The experimental conditions in this pre-experiment were the same as described for the experiment I below (plate incorporation test). Toxicity of the test article can be evidenced by a reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn. Dose Selection
According to the results of the pre-experiment the concentrations applied in the main experiments were chosen.
Due to toxic effects, the maximum concentration was 5000.0 flg/plate (strains TA 98 and TA 100) in the pre-experiment and in experiment I and 1000.0 flg/plate (strains TA 1535, TA 1537, and TA 102) in experiment I and in experiment II (all strains). The con-centration range included two logarithmic decades. In this study six adequately spaced concentrations were tested. Two independent experiments were performed. As the re-sults of the pre-experiment were in accordance with the criteria, these data are reported as a part of the main experiment
According to the dose selection criteria the test article was tested at the following
concentrations:
Exp. I; strains TA 98 and TA 100:33.3; 100.0; 333.3; 1000.0; 2500.0; 5000.0 µg/plate
Exp. I; strains TA 1535, TA 1537, TA 102; Exp: II; all strains: 10.0; 33.3; 100.0; 333.3; 666.6; 1000.0 µg/plate
Experimental Performance
For each strain and dose level, including the controls three plates were used as a mini-mum. The following materials were mixed in a test tube and poured onto the selective agar plates:
100 µI Test solution at each dose level, solvent (negative control) or reference mutagen
solution (positive control),
500 µI S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test
without metabolic activation),
100 µI Bacteria suspension (cf. test system, pre-culture of the strains),
2000 µl Overlay agar
In the pre-incubation assay 100 fll test solution, 500 fll S9 mix I S9 mix substitution buffer and 100 µl bacterial suspension were mixed in a test tube and incubated at 37°C for 60 minutes.
After pre-incubation 2.a ml overlay agar (45° C) was added to each tube. The mmixture was poured on minimal agar plates. After solidification the plates were incubated upside down for at least 48 hours at 37°C in the dark. - Evaluation criteria:
- The generally accepted conditions for the evaluation of the results are:
- corresponding background growth on both negative control and test plates
- normal range of spontaneous reversion rates.
A test article is considered mutagenic if the number of reversions is at least twice the
spontaneous reversionrate in strains TA 100 and TA 102 or thrice on TA 1535, TA 1537,
and TA 98 (4).
Also, a dose-dependent and reproducible increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the criteria described above or not.
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test article Dimetbyl-2-ch1oroacetoacetamide (97.3% pure) was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102 according to OECD guideline 471.
The assay was performed in two independent experiments both with and without liver micro-somal activation. Each concentration and the controls, were tested in triplicate. The test article was tested at the following concentrations:
Exp.I; strainsTA98 andTA 100: 33.3; 100.0;333.3;1000.0;2500.0;5000.0µg/plate
Exp.l; strainsTA 1535,TA 1537,TA 102 and Exp:II; all strains: 10.0; 33.3; 100.0; 333.3; 666.6; 1000.0 µg/plate
Distinct toxic effects, evidenced by a reduction in the number of revertants, occurred in all strains in experiment I. Strain TA 1535 showed toxic effects at 1000.0 µg/plate without S9 mix, strain TA 1537 from 666.6 up to 1000.0 µg/plate with and without S9 mix, strain TA 98 from 1000.0 up to 5000.0 µg/plate without S9 mix, strain TA 100 from 25000 up tom5000.0 µg/plate with and without S9 mix and strain TA 102 from 666.6 up to 1000.0m µg/plate without S9 mix. In experiment II, toxic effects occurred in strain TA 102 at 1000.0m µg/plate with and without S9 mix.
The plates incubated with the test article showed normal background growth up to the highest investigated dose with and without S9 mix in all strains used. No substantial increases in rever-tant colony numbers of any of the five tester strains were observed following treatment with Di-metbyl-2-ch1oroacetoacetamide at any concentration level, either in the presence or absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with in-creasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls. They showed a dis-tinct increase in induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the ex-perimental conditions reported, the test article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
The test article Dimetbyl-2-ch1oroacetoacetamide (97.3% pure) was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102 according to OECD guideline 471.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls, were tested in triplicate. The test article was tested at the following concentrations:
Exp.I; strainsTA98 andTA 100: 33.3; 100.0;333.3;1000.0;2500.0;5000.0µg/plate
Exp.l; strainsTA 1535,TA 1537,TA 102 and Exp:II; all strains: 10.0; 33.3; 100.0; 333.3; 666.6; 1000.0 µg/plate
Distinct toxic effects, evidenced by a reduction in the number of revertants, occurred in all strains in experiment I. Strain TA 1535 showed toxic effects at 1000.0 µg/plate without S9 mix, strain TA 1537 from 666.6 up to 1000.0 µg/plate with and without S9 mix, strain TA 98 from 1000.0 up to 5000.0 µg/plate without S9 mix, strain TA 100 from 25000 up tom5000.0 µg/plate with and without S9 mix and strain TA 102 from 666.6 up to 1000.0m µg/plate without S9 mix. In experiment II, toxic effects occurred in strain TA 102 at 1000.0m µg/plate with and without S9 mix.
The plates incubated with the test article showed normal background growth up to the highest investigated dose with and without S9 mix in all strains used. No substantial increases in revertant colony numbers of any of the five tester strains were observed following treatment with Dimetbyl-2-ch1oroacetoacetamide at any concentration level, either in the presence or 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. They showed a distinct increase in induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
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