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EC number: 208-952-0 | CAS number: 548-61-8
- 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: GLP Study, only 4 Salmonella strains used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- Salmonella/microsome test, plate incorporation assay, as described by Ames et al., (1973a, 1975) and Maron and Ames (1983); only 4 Salmonella strains used
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4',4''-methylidynetrianiline
- EC Number:
- 208-952-0
- EC Name:
- 4,4',4''-methylidynetrianiline
- Cas Number:
- 548-61-8
- Molecular formula:
- C19H19N3
- IUPAC Name:
- 4,4',4''-methylidynetrianiline
Constituent 1
Method
- Target gene:
- mutant histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix was made from the livers of male Sprague Dawley rats, which received a single intraperitoneal injection of 500 mg/kg bw Aroclor 1254, dissolved in corn oil, 5 days prior to sacrifice. The S9 mix comprised 30 % S9 fraction.
- Test concentrations with justification for top dose:
- plate incorporation assay:
0, 8, 40, 200, 1000, and 5000 µg/plate with and without S9 mix (first and second trial) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
The highest dose of Delta-R-Base was applied as suspension.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Na-azide (only TA 1535), nitrofurantoin (only TA 100), 4-nitro-1,2-phenylene diamine (TA 1537 and TA 98), 2-aminoanthracene
- Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgment.
In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible. - Statistics:
- no statistics performed; evaluation based on criteria mentioned above
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- On TA 100 and TA 98 a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was found only with S9 mix at 40 µg/plate (TA 100) and 8 µg/plate (TA 98).
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5000 µg/plate the substance had a weak, strain specific bacteriotoxic effect, so that dose could nevertheless be used for assessment purposes. Substance precipitation occurred at 5000 µg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Two of the five strains (TA 98 and TA 100) in the plate incorporation test with S9 mix showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. For TA 98 this increase was even higher than that of the positive control 2-aminoanthracene. TA 98 counts for frameshift effects and TA 100 for base-pair substitution.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary and mean values with S9 mix
Table and group µg/plate |
Strain TA 1535 |
Strain TA 100 |
Strain TA 1535 |
Strain TA 98 |
+ S9 (30 %)
|
plates 1-4 / 5-8 |
|||
0 (Ethanol) |
20 / 14 |
147 / 146 |
10 / 9 |
53 / 53 |
8 |
20 /15 |
188 /143 |
14 / 14 |
242 / 291 |
40 |
21 /16 |
257 / 292 |
23 / 20 |
521 / 485 |
200 |
24 /13 |
379 / 413 |
17 / 19 |
502 / 638 |
1000 |
18 / 17 |
426 / 370 |
26 / 24 |
499 / 601 |
5000 |
20 / 16 |
444 / 432 |
23 / 25 |
P / P |
2-AA (pos. control) |
204 / 84 |
758 / 902 |
81 / 81 |
437 / 381 |
P = precipitation
numbers in bold show values which led to a statistical significance in
the respective quotients
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation - Executive summary:
The test substance was investigated in the Ames Test using Salmonella typhimurium strains TA 1535, TA 100, TA 1537, and TA 98 for point mutagenic effects in doses of 8 up to 5000 µg/plate. At 5000 µg/plate a weak, strain specific bacteriotoxic effect and precipitation of the test substance appeared. Clear evidence of mutagenic activity of the test substance was seen in cultures with S9-mix at doses of >= 8 µg/plate for TA 98 and at >= 40 µg/plate for TA 100. For TA 98 the dose-dependent increase reached higher mutant frequencies than the positive control 2-aminoanthacene. TA 98 and TA 100 cover different mutagenic effects, i.e. frameshift effects and base-pair substitution, respectively. Thus, the test substance should be regarded as a potent and definite mutagen under the conditions of the Salmonella/microsome assay.
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