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EC number: 210-716-7 | CAS number: 621-95-4
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well performed study following scientiffic priciples in compliance with GLP. A deviating set of tester strains as compared to actual guidelines was used.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Ames, B.N., Mc Cann, J. and Yamasaki, E., Mutation Res. (1975), 31, 347-364
- Principles of method if other than guideline:
- A deviating set of tester strains as compared to actual guidelines was used.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-ethylenedianiline
- EC Number:
- 210-716-7
- EC Name:
- 4,4'-ethylenedianiline
- Cas Number:
- 621-95-4
- Molecular formula:
- C14H16N2
- IUPAC Name:
- 4-[2-(4-aminophenyl)ethyl]aniline
Constituent 1
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 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254(R) induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 1.58, 5, 15.8, 50, 158, 500, 1580 and 5000 µg / plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- methylmethanesulfonate
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1,537 and TA 1538, obtained from B.N. Ames, University of California,
Berkeley CA, 947?0, USA, May 1?81.
The bacteria were grownn in a shaking water bath for 16 hours overnight at 37 degrees centigrade in 2.5% Nutrient Broth No. 2x..
After centrifugation, the bacteria were resuspended to a concentration of approximately 1 x 10 ep. 8 to 2 x 10 exp 9 cells per milliliter in 0.16 % Nutrient Broth and 0.5 % Sodium chloride. The concentration of germs was controlled photometrically and determined in an experimental test with
Histidine-rich potassium chloride solution on selective agar plates .
The plates were incubated at 37 degrees centigrads in the dark for 3 days. - Evaluation criteria:
- A material is identified as a mutagen in this test system if there is a reproducible demonstration of a dose effect relation with a 2-foId increase in the number of revertants over the controls in a minimum of one strain.
With the strain TA 100 a 1.5-foId increase is the criterion for a positive result. - 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
- Genotoxicity:
- positive
- Remarks:
- except TA 1537
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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):
positive
In conclusion, it can be stated that during this in vitro SaImonella./mammalian-microsome assay and under the experimental conditions reported, the test item showed a reproducible dose-dependent mutagenic activity when tested with liver microsomal activation. - Executive summary:
This study was performed to investigate the mutagenic activity of the test item according to the plate incorporation test of Ames et. al . using the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538.
The test was performed with and without rat liver microsomal activation. The test material was tested at the following concentrations: 0, 1.58, 5, 15.8, 50, 158, 500, 1580 and 5000 micrograms per plate. Each concentrration, including the controls, was tested in triplicate.
No toxic effect of the test material was observed.
In the experiment without metabolic activation, no relevant increase of the revertant colony numbers was obtained in any SaImoneIla typhimurium strain, used at all dose levels tested when compared with the corresesponding controls.
In the experiment without metabolic activation no relevant increas of the revertant colony numbers was obtained in any tester strain. In the experiment with metabolic activation, a dose-dependent increase in the number of revertants was observed in all tester strains with the exception of TA 1537. A mutagenic activity of the test material was ascertained at the concentrations starting from 15.8 µg per plate. These findings were confirmed in an independent second experiment.
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