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Diss Factsheets
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EC number: 204-826-4 | CAS number: 127-19-5
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (partly limited documentation, e.g. no details about test substance or no tabulated details on results; no data on cytotoxicity in bone marrow; only 50 cells per rat analysed [100 cells recommended]; MTD presumably not reached)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- (only 50 metaphases scored)
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- N,N-dimethylacetamide
- EC Number:
- 204-826-4
- EC Name:
- N,N-dimethylacetamide
- Cas Number:
- 127-19-5
- Molecular formula:
- C4H9NO
- IUPAC Name:
- N,N-dimethylacetamide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: dimethylacetamide (DMAC)
No details available.
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet and water ad libitum but not during exposure.
- Some evidence for sialodacryoadenitis (SDA Virus; natural occurring pathogen in rats) in all rats.
- Housing: males caged individually
no further details available
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- see details of exposure
- Details on exposure:
- Whole body exposure; generation by bubbling nitrogen through DMAC contained in a glass gas washing bottle (50 °C); vapour mixture diluted with filtered, compressed air; atmospheres in the exposure chambers were dynamic (continuously generated for a single pass through the animal holding zone); concentrations within the exposure chambers maintained by regulating the flow of nitrogen and diluting air into the mixing vessels.
Continuously monitoring in the breathing zone by infra-red gas analysers; calibrations performed.
Chamber relative humidity and temperature was measured every hour.
After exposure rats observed for clinical signs, ear numbers checked, body weights recorded and returned to their cages. - Duration of treatment / exposure:
- 7 h
- Frequency of treatment:
- once or for five days
- Post exposure period:
- Three different sampling times: 6, 24 or 48 h after the last exposure rats were sacrificed; 2 h prior to sacrifice were i.p. injected with 3 mg/kg bw colchicine.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 ppm (nominal)
- Remarks:
- 70 mg/m³
analytical data revealed deviations from the target concentrations of more than +-10% were limited to 20 min high (20 ppm target concentration) and 40 min low, 30 min high (700 ppm target concentration); no further details
- Dose / conc.:
- 700 ppm (nominal)
- Remarks:
- 2500 mg/m³
analytical data revealed deviations from the target concentrations of more than +-10% were limited to 20 min high (20 ppm target concentration) and 40 min low, 30 min high (700 ppm target concentration); no further details
- No. of animals per sex per dose:
- no details available
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Yes, single gavage with 250 mg/kg bw ethyl methanesulfonate.
Examinations
- Tissues and cell types examined:
- Bone marrow cells; investigated abnormalities: gaps, breaks, fragments, dicentrics, translocations (within the limitations of the staining methods), and pulverisation
- Details of tissue and slide preparation:
- Bone marrow cell suspension prepared, fixed and dried on slides and examined by light microscopical methods after staining with Giemsa R66.
50 cells with well-spread chromosomes per animal examined on a blind basis. - Evaluation criteria:
- Statistical significance (a) including all chromosomal abnormalities and (b) excluding cells only exhibiting gaps.
- Statistics:
- The data were transformed using the Freeman-Tukey transformation.
A one-sided Student's t test was used on the transformed values.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Significant effects in positive controls (breaks with fragments, exchanges and multiple aberrations), especially after the post exposure period of 48 h. No increase in the incidences of chromosomal aberrations in the treatment groups.
Any other information on results incl. tables
Data on acute inhalation toxicity in Section 7.2.3 suggested no toxic effects at a dose level of 700 ppm.
Applicant's summary and conclusion
- Conclusions:
- No clastogenic activity was detected in the bone marrow of rats after inhalation exposure to 700 ppm (2500 mg/m³).
- Executive summary:
The Tier II mutagenic screening of the test substance was conducted according to OECD 475 in 1980. GLP compliance was not specified. A cytogenetic analysis of rat bone marrow cells was performed after in vivo exposure to 20 or 700 ppm of the test substance for seven hours per day for 1 or 5 days in male and female rats. A positive (single gavage with 250 mg/kg bw ethyl methanesulfonate) control and a negative control was included. Sampling times were 6 h, 24 h, and 48 h post-exposure. The frequencies of chromosomal aberrations were not increased significantly in the rat bone marrow cells.
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