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EC number: 234-123-8 | CAS number: 10543-57-4
- 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: The study is in accordance to common test guidelines and GLP and therefore rated as reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 26 May 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- adopted 26 May 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N'-ethylenebis[N-acetylacetamide]
- EC Number:
- 234-123-8
- EC Name:
- N,N'-ethylenebis[N-acetylacetamide]
- Cas Number:
- 10543-57-4
- Molecular formula:
- C10H16N2O4
- IUPAC Name:
- N,N'-ethylenebis[N-acetylacetamide]
- Details on test material:
- - Name of test material (as cited in study report): TAED
- Colour: white
- Aggregate state at rt: solid
- Analytical purity: approx. 99.5%
- Lot/batch No.: E 12 T 24020 dated April, 1988
- Storage condition of test material and stability: room temperature, moisture protected, stable for months
Constituent 1
Method
- Target gene:
- -
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100; E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- microsomal fraction from Aroclor 1254 induced rat livers
- Test concentrations with justification for top dose:
- 10, 33.3, 100, 333.3 and 500 µg/plate
- Vehicle / solvent:
- - solvent used: deionized water
- Justification for choice of solvent/vehicle: solubility of test item
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: WITHOUT METABOLIC ACTIVATION sodium azide (TA 1535, TA 100), 4-nitro-o-phenylene-diamine (TA 1537, TA 1538, TA 98), MMS (WP2), WITH METABOLIC ACTIVATION 2-aminoanthracene (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
Plates were incubated upside down for 72 hours at 37°C .
NUMBER OF REPLICATIONS: 2 independent experiments, 3 plates per concentration
DETERMINATION OF CYTOTOXICITY
- Method: evaluation of number of spontaneous revertants and bacterial background lawn - Evaluation criteria:
- A test item is considered as a mutagen if in strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537, TA 1538 and TA 98 is at least three times higher as compared to the spontaneous reversion rate.
A dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test item regardless whether the highest dose induced the above described enhancement factors or not.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100; E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: can be excluded
- Effects of osmolality: can be excluded
- Evaporation from medium: none
- Water solubility/ Precipitation:
The limit of solubility of the test article in H2O bidest was obtained at a concentration of 500.0 pg/plate. At this concentration still some particles of the test article remained undissolved.
The undissolved particles had no influence on the data recording. It was not possible to test higher concentrations of the test article than 500.0 pg/plate as no data recording could be performed.
- Other confounding effects: none - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
see attachment
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the experimental conditions reported the test item did not induce point mutations by base pair changes or
frameshifts in the genome of the strains used. - Executive summary:
TAED was tested in the plate incorporation assay at concentrations of 10, 33.3, 100, 333.3 and 500 µg/plate using the Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 and in addition the Escherichia coli strain WP2 with and without S9-mix (microsomal fraction from Aroclor 1254 induced rat livers). Two independent experiments were performed. Each concentration, including negative, solvent and positive controls, was tested in triplicate. Deionized H2O was chosen as solvent for TAED. 500 µg/plate was selected as the highest test concentration, since the test substance was partially insoluble at this concentration. Alternative solvents like DMSO, DMF, ethanol or acetone showed no better solubility properties. No distinct toxic effects occurred in the test groups. Up to the highest dose, no significant and reproducible increase in revertant colony numbers was obtained in any of the strains used.
TAED did not induce mutations in the genome of the bacterial strains used.
The study is in accordance with common test guidelines and GLP and therefore rated as reliable without restrictions (data quality score 1).
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