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EC number: 252-021-1 | CAS number: 34432-92-3
- 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
- Study period:
- 30.08.-9.11.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out in accordance with internationally valid GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- (see Overall remarks)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]-4-(phenylazo)aniline
- EC Number:
- 252-021-1
- EC Name:
- N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]-4-(phenylazo)aniline
- Cas Number:
- 34432-92-3
- Molecular formula:
- C22H31N3O2
- IUPAC Name:
- N-ethyl-N-[2-(1-isobutoxyethoxy)ethyl]-4-(phenyldiazenyl)aniline
- Test material form:
- liquid: viscous
- Details on test material:
- Name of test material (as cited in study report): Solvent Yellow 124
Substance type: organic
Physical state: liquid
Appearance: dark yellow viscous liquid
Composition of test material, percentage of components:
- Analytical purity: 90.0 % (w/w)
- Impurities (identity and concentrations):
4´-[2-((hydroxy)ethyl)ethylamino]azobenzene 3.0 % (w/w)
1,1-bis(N-ethyl[4-(phenylazo)phenyl]aminoethan-2-oxy)ethan 2.5 % (w/w)
- Unknown impurities 4.5 % (w/w)
Lot/batch No.: S2408
Expiration date of the lot/batch: Unlisted
Stability under test conditions: stable
Storage condition of test material: During the study the test substance was stored in glass bottle at laboratory temperature.
Constituent 1
Method
- Target gene:
- gene for synthesis histidine or tryptophan
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: histidine requiring strain
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: tryptophan requiring strain
- Metabolic activation:
- with and without
- Metabolic activation system:
- postmitochondrial fraction (S9)
- Test concentrations with justification for top dose:
- 5, 15, 50, 150, 500, 1500, 5000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide for analysis (purity>99.9%), Merck, Lot No. K41063052 028
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Dimethylsulfoxide)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylenediamine; 9-aminoacridine hydrochloride monohydrate; 2-aminofluorene; 2-aminoanthracene; N-methyl-N'-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation)
NUMBER OF REPLICATIONS:
two series of experiments were performed with each strain - without and with metabolic activation, triplicate plating was used at each dose level
DETERMINATION OF CYTOTOXICITY
- Method: total growth - Evaluation criteria:
- The main criterion for evaluation of results was modified two-fold increase rule which is compatible with the aplication of statistical methods. After this rule the result is positive, if a reproducible dose-response effect occurs and/or a doubling of the ratio Rt/Rc is reached.
- Statistics:
- For the evaluation of results, the modified two-fold increase rule was used, which is compatible with the application of statistical methods (2, 3).
2. Dunkel V. C., Chu K.C. (1980): Evaluation of methods for analysis of microbial mutagenicity assays, in The Predictive Value of Short-Term Screening Tests in Carcinogenicity Evaluation, Elsevier North-Holland Biomedical Press, 231 - 240
3. Claxton L. D. et al. (1987): Guide for the Salmonella typhimurium/mammalian microsome tests for bacterial mutagenicity, Mutat. Res. 189, 83 - 91
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:
- other: no toxicity with TA 100 (without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- ambiguous slight mutagenic effect
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- 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'.
Any other information on results incl. tables
The results obtained in most experiments did not show substantial (biologically significant) increases in the number of revertants versus solvent controls (Rt/ Rc < 2), and no experiment gave evidence of a rising trend in the number of revertants with increasing dose.
In some cases, experiments with increased values of revertants occurred, exclusively with metabolic activation. It concerns the following experiments:
- TA 100 +MAII, trend to 500 µg per plate Rt/Rc max =1.5;
- TA 1535 +MAI trend to 1500 µg per plate Rt/Rc max =1.7;
- TA 98 +MAI trend to 500 µg per plate ,max Rt/Rc 1.9 and experiment +MAII, max Rt/Rc =1.6;
- E. coli + MAII, without any trend, max. Rt/Rc =1.5; increase caused rather by lower solvent control value.
In case of TA 100, TA 1535 and E.coli the results were neither confirmed by the parallel experiments nor Rt/Rt reached 2. In case of TA 98, increased values of revertants were observed in both experiments, while dose-response relationship was observed in the first experiment only. It could be caused relatively small enhancement of number of revertants and large variability of the biological system. Anyway, such increasing is not common in negative experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
other: negative, but result of TA 98 with metabolic activation could be evaluated as ambiguous slight mutagenic effect
Under the above-described experimental design, the test substance Solvent Yellow 124 was nonmutagenic for all the Salmonella typhimurium as well as Escherichia coli strains in experiments without metabolic activation. It was nonmutagenic also for Salmonella typhimurium TA 100, TA 1535 and TA 1537 and for Escherichia coli WP2 uvrA with metabolic activation. The results in Salmonella typhimurium TA 98 with metabolic activation could be evaluated as ambiguous slight mutagenic effect. - Executive summary:
Test substance Solvent Yellow 124 was assayed for the mutagenicity by the Bacterial Reverse Mutation Test.
The performed test was based on EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471.
Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used. The test substance was dissolved in dimethylsulfoxide and assayed in doses of 5-5000 µg, which were applied to plates in volume of 0.1 mL.
Experiments were performed without as well as with metabolic activation with a supernatant of rat liver and a mixture of cofactors.
In the arrangement given above, the test substance Solvent Yellow 124 was nonmutagenic for all the Salmonella typhimurium as well as Escherichia coli strains in experiments without metabolic activation. It was nonmutagenic also for Salmonella typhimurium TA 100, TA 1535 and TA 1537 and for Escherichia coli WP2 uvrA with metabolic activation.
The results in Salmonella typhimurium TA 98 with metabolic activation could be evaluated as ambiguous slight mutagenic effect.
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