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EC number: 603-014-0 | CAS number: 124772-04-9
- 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: Guideline Study, well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Validity criteria were taken from the literature and DIN guideline, since in OECD and EC guideline no validity criteria are described.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-[(1E)-2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl]benzoic acid
- EC Number:
- 603-014-0
- Cas Number:
- 124772-04-9
- Molecular formula:
- C17 H15 N3 O4
- IUPAC Name:
- 4-[(1E)-2-[2-oxo-1-(phenylcarbamoyl)propyl]diazen-1-yl]benzoic acid
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:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-fraction from livers of male Wistar rats
- Test concentrations with justification for top dose:
- TA 1537, TA98, TA 100, TA 1535: 0.016-0.05-0.16-0.5-1.6 mg/plate
EC WP2 (uvrA): 0.05-0.16-0.5- 1.6-5.0 mg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- other: 4-Nitro-o-phenylene-diamine, 2-Aminoanthracene, Nitrofurantoine, ICR 191
- Details on test system and experimental conditions:
- TEST SYSTEM: Salmonella typhimurium strains TA 1537, TA 98, TA 100 and TA 1535 and Escherichia coli EC WP2 (uvrA) with (+) and without (-) metabolic activation system (S9). Salmonella typhimurium strains Escherichia coli EC WP2 and were selected according to OECD / EC guideline.
Origin:
University of California, Berkeley Divison of Biochemistry & Molecular Biology, CA 94720 USA (TA 98, TA 100)
TRINOVA BIOCHEM GMBH, Kerkrader Strafte 10, 35394 Gieften (E coli WP2 (uvrA), TA1535, TA1537) derived from master culture obtained directly from University of California)
Storage at test facility: Under liquid nitrogen (< -80 °C)
Inoculum: An overnight culture was prepared. Incubation was performed for 18 h at 37 °C. Titer of the overnight culture was > 1 x 108 cells/mL.
Metabolic activation system (S9):
As metabolic activation system a post-mitochondrial (S9) fraction from livers of male Wistar rats, which were induced with Phenobarbital intraperitoneally and ß-Naphtoflavone orally was used. The S9 fraction was received from CCR (In den Leppsteinwiesen 19, D-64380 Roftdorf). At test start an aliquot of the S9-fraction was thawed and enriched with cofactors according to DIN Guideline 38415 part 4 (S9-Mix). Batch number of each S9-fraction was 040205 (34.7 mg protein/mL S9).
Media: According to DIN Guideline 38415 Part 4 (December 1999)
Test container: Petri dishes with cams (0 94 mm, 16 mm high) with about 25 mL. VOGEL-BONNER minimal medium (for strain TA 97a with 0.4 % D+ Glucose, for alt other strains with 2 % D+ Glucose)
Application / Composition of test media: 2.0 mL top agar with 0.5 mM Histidin-/Biotin-solution for plates without metabolic activation system 1.5 mL top agar with 0.5 mM Histidin-/Biotin-solution for plates with metabolic activation system 0.5 mL S9-Mix for plates with metabolic activation system 0.1 mL test item-solution, reference item-sotution and aqua bidest. for controls, respectively 0.1 mL bacteria (overnight culture)
Titer control.: 2.0 mL top agar with 5 mM Histidin- / 0.5 mM Biotin-soiution, 0.5 mL S9-Mix, 0.1 mL bacteria (10"5 dilution from overnight culture)
Replicates: Three replicates per concentration level and control. Titer control replicates were prepared 2-fold.
Genotypes: The genotypes of the tested strains will be checked in the course of every study: histidine and tryptophan auxotrophy, respectively, ampiciliin resistance, UV-sensitivity and growth inhibition by crystal violet.
Based on the results of a preliminary test (NON-GLP) the test concentrations were selected. Stock solutions were freshly prepared with DMSO. Each inoculum was an overnight culture with a titer > 1 -10s cells/mL. Two independent studies were conducted as described above. Evaluations were performed as described below.
KIND AND FREQUENCY OF MEASUREMENT AND OBSERVATION
Genotypes were evaluated for each study. Plates of the mutagenicity test were inspected for present and reduced background lawn after an incubation time of 48 h. Colonies per plate (revertants) were counted, if no reduced background lawn was observed.
Plates with colonies which correspond not with the typical shape and colour of Salmonella typhimurium and Escherichia coli were regarded as contaminated and were not included in calculations.
- Evaluation criteria:
- Since a reduced background lawn is regarded to be a cytotoxic effect, plates with reduced background lawn were not included into evaluationprocedures. Arithmetic mean values and standard deviations were calculated from colonies per plate of three replicates.
For evaluation of the results the induction rate of the mean values was calculated (1):
Induction rate = revertant colonies of test item / revertant colonies of the corresponding control
The test item is to be interpretated mutagenic if a concentration effect relationship occurred and the induction rate is > 2.
The following genotypes of the tested strains had to be confirmed:
- Histidine auxotrophy / tryptophan auxotrophy
- Ampicillin resistance
- UV-sensitivity (except TA 102)
- Growth inhibition with crystal violet (rfa-mutation)
Titer of the overnight culture had to be > 1 • 108 cells/mL
Spontaneous revertants/plate (negative controls) should be within the following ranges:
-TA1537 ±S9 : 2-40
-TA 98 + S9 :15-50
-TA100 ±S9 :60 - 200
-TA 1535±S9 : 5-30
-EC WP2 + S9 : 3-100
The induction rates of the positve controls had to be > 2.
Results and discussion
Test results
- 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
- 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
Revertant colonies of the test item plates are given in tables 5 - 24. Spontaneous revertants are listed in tables 3 - 4. The arithmetic mean value and the standard deviation were calculated out of the three replicates of the revertant colony plates. For evaluation of the results the induction rates of the mean values were calculated.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In this study Polyalkylene Yellow Monoazo was found to have no mutagenic effects on Salmonella typhimurium strains TA 1537, TA 98, TA 100 and TA 1535 Escherichia coli EC WP2 with (+) and without (-) the metabolic activation system S9 from male Wistar rats.
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