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EC number: 228-768-4 | CAS number: 6358-31-2
- 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:
- 29 November 2006 to 08 December 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: performed in accordance with OECD and GLP guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to German Chemikaliengesetz and OECD Principles of Good Laboratory Practice
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- EC Number:
- 228-768-4
- EC Name:
- 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- Cas Number:
- 6358-31-2
- Molecular formula:
- C18H18N4O6
- IUPAC Name:
- 2-[(2-methoxy-4-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Pre-Experiment and Experiment I: 0 (control), 3, 10, 33, 100, 333, 1000, 2500, 5000 µg/plate
Experiment II: 0 (control), 33, 100, 333, 1000, 2500, 5000 µg/plate - Vehicle / solvent:
- Ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see below for additional information
- Details on test system and experimental conditions:
- The assay was performed in two independent experiments:
experiment I: plate incorporation assay with and without induced rat liver S9 mix
experiment II: pre-incubation test with and without non-induced hamster liver S9 mix
Hamster liver S9 mix, but not rat liver S9 mix, contained the reductive agent FMN.
DURATION
- Preincubation period: 30 min, 30°C
- Exposure duration: after solidification the plates were incubated upside down for at least 48 hours at 37°C in the dark
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: existence of evaluable plates (> 0 colonies) at five concentrations or more
POSITIVE CONTROL SUBSTANCES:
without metabolic activation: sodium azide (TA 1535, TA 100), 4-nitro-o-phenylene-diamine ((TA 1537, TA 98), methyl methane sulfonate (WP2 uvrA);
with metabolic activation: 2-aminoanthracene (all strains with rat liver S9 mix and TA 1535, TA 100, TA 1537, WP2 uvrA with hamster liver S9 mix), cKongo red (TA 98 with hamster liver S9 mix) - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- cytotoxicity
- Remarks:
- Experiment I, TA 1537, without metabolic activation: minor reduction in number of revertants at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Mean mutant number ratios treated/solvent control
Exp. I: plate incorporation method without S9 mix
Concentrations given in µg/plate
Strain -- 3 -- 10 -- 33 -- 100 -- 333 -- 1000 -- 2500 -- 5000
TA1535 -- 1.0 -- 0.8 -- 0.8 -- 1.1 -- 0.8 -- 0.7 -- 0.9 -- 0.7
TA1537 -- 1.5 -- 1.1 -- 0.9 -- 0.9 -- 0.9 -- 1.3 -- 0.9 -- 0.4
TA98 -- 0.9 -- 1.0 -- 1.0 -- 1.1 -- 0.8 -- 0.9 -- 0.9 -- 0.7
TA100 -- 0.8 -- 0.9 --1.0 -- 1.1 -- 0.9 -- 1.0 -- 0.9 -- 0.8
WP2uvrA -- 1.0 -- 1.0 -- 1.1 -- 1.2 -- 0.9 -- 0.9 -- 0.8 -- 0.8
Exp. I: plate incorporation method with rat S9 mix
Concentrations given in µg/plate
Strain -- 3 -- 10 -- 33 -- 100 -- 333 -- 1000 -- 2500 -- 5000
TA1535 -- 1.1 -- 1.1 -- 1.1 -- 1.0 -- 1.1 -- 1.2 -- 1.2 -- 0.7
TA1537 -- 1.1 -- 0.9 -- 1.1 -- 1.3 -- 1.1 -- 0.9 -- 0.9 -- 0.7
TA98 -- 1.1 -- 1.1 -- 1.1 -- 1.0 -- 0.9 -- 0.9 -- 1.0 -- 0.8
TA100 -- 1.0 -- 1.1 --1.0 -- 1.0 -- 1.0 -- 1.0 -- 0.9 -- 0.8
WP2uvrA -- 1.0 -- 1.0 -- 0.9 -- 0.9 -- 0.9 -- 0.8 -- 0.8 -- 0.8
Exp. II: pre-incubation method without S9 mix
Concentrations given in µg/plate
Strain -- 33 -- 100 -- 333 -- 1000 -- 2500 -- 5000
TA1535 -- 1.2 -- 0.9 -- 1.0 -- 0.9 -- 1.0 -- 0.9
TA1537 -- 1.2 -- 1.3 -- 1.4 -- 1.4 -- 1.1 -- 0.9
TA98 -- 1.0 -- 1.2 -- 0.9 -- 1.1 -- 0.8 -- 0.7
TA100 --1.2 -- 1.1 -- 1.1 -- 1.1 -- 0.9 -- 1.0
WP2uvrA -- 1.2 -- 0.9 -- 1.1 -- 0.9 -- 1.0 -- 0.9
Exp. II: pre-incubation method with hamster S9 mix
Concentrations given in µg/plate
Strain -- 33 -- 100 -- 333 -- 1000 -- 2500 -- 5000
TA1535 -- 0.9 -- 0.8 -- 0.7 -- 0.7 -- 0.7 -- 0.7
TA1537 -- 1.3 -- 1.0 -- 1.1 -- 0.8 -- 0.8 -- 0.8
TA98 -- 1.0 -- 1.0 -- 1.0 -- 1.0 -- 0.7 -- 0.7
TA100 --1.0 -- 0.8 -- 1.0 -- 0.9 -- 0.8 -- 0.7
WP2uvrA -- 1.2 -- 0.8 -- 0.7 -- 1.0 -- 0.9 -- 0.7
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
During the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by
frameshifts or base-pair substitutions in the genome of the strains used. Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of the test substance to induce gene mutations according to the plate incorporation assay with rat liver S9 (experiment I) and the pre-incubation test with hamster liver S9 (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I : 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both experiments.
No toxic effects, evident as a reduction in the number of revertants, were observed with and without metabolic activation in all strains. Only in experiment I in strain TA 1537 in the absence of metabolic activation a minor reduction in the number of revertants, were observed at 5000 µg/plate.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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