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EC number: 700-501-0 | CAS number: -
- 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:
- 2008-04-21 to 2008-08-19
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- IUPAC Name:
- Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Reference substance name:
- Acid Yellow 42: 6375-55-9
- IUPAC Name:
- Acid Yellow 42: 6375-55-9
- Reference substance name:
- Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
- IUPAC Name:
- Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
- Reference substance name:
- Basic Violet 1: 8004-87-3
- IUPAC Name:
- Basic Violet 1: 8004-87-3
- Details on test material:
- - Name of test material: Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Lot/batch No.: 2008041541
- Expiration date of the lot/batch: 2010-01-31
- Stability under test conditions: see expiry date
- Storage condition of test material: store cool and dry
- Analytical purity: 100 % (96.8 %, UVCB substance)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- Five bacterial strains, Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 uvrA were used to investigate the mutagenic potential of F 46 Black in independent experiments, in plate incorporation tests and in pre-incubation tests.
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Based on the results of a preliminary toxicity test concentrations were chosen for the plate incorporation tests (initial and complementary) and pre-incubation tests (initial and complementary).
In the initial mutation test (plate incorporation test) the examined concentration levels were: 60; 24; 9.6; 3.84; 1.536; 0.614 and 0.246 μg/plate (Salmonella typhimurium strains) and 500; 158.1; 50; 15.81; 5; 1.581 and 0.5 μg/plate (Escherichia coli WP2 uvrA). In the complementary plate incorporation test only the Escherichia coli WP2 uvrA was examined at the concentration levels of 5000 and 1581.1 μg/plate (±S9 Mix).
In the confirmatory mutation pre-incubation test the examined concentration levels were in case of Salmonella typhimurium strains: 24; 9.6; 3.84; 1.536; 0.614; 0.246 and 0.098 μg/plate. In case of Escherichia coli WP2 uvrA the 1581.1; 500; 158.1; 50; 15.81; 5 and 1.581 μg/plate concentration levels were tested. In the complementary pre-Incubation test the examined concentration levels were in case of in case of Salmonella typhimurium TA 98 and TA 100: 375; 150; 60 and 24 μg/plate (+S9 Mix), in case of Salmonella typhimurium TA 1535: 150; 60; 24; 0.098 and 0.031 μg/plate (+S9 Mix), the concentration levels of 0.098 and 0.031 μg/plate in absence of metabolic activation (–S9 Mix) were also tested, in case of Salmonella typhimurium TA 1537: 150; 60 and 24 μg/plate (+S9 Mix). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO, distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 98
- Positive control substance:
- other: 4-Nitro-1,2-phenylenediamine, 4-NOPD (or NPD)
- Remarks:
- 4 μg/plate, without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 100; TA 1535
- Positive control substance:
- sodium azide
- Remarks:
- 2 µg/plate, without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 50 µg7plate, without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- E. coli WP2uvrA
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- 2 µL/plate, without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 100; TA 98; TA1535; TA 1537 and E. coli WP2uvrA
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- 2 μg/plate for S. typhimurium strains; 50 μg/plate for E. coli WP2uvrA; With metabolic activation [10 % (v/v) rat liver]
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 100; TA1535; TA 1537 and E. coli WP2uvrA
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- 2 μg/plate for S. typhimurium strains; 50 μg/plate for E. coli WP2uvrA; With metabolic activation [30 % (v/v) hamster liver]
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 98
- Positive control substance:
- congo red
- Remarks:
- 250 μg/plate; With metabolic activation [30 % (v/v) hamster liver]
- Evaluation criteria:
- A test item is considered mutagenic if: – a dose–related increase in the number of revertants occur and/or
– a reproducible biologically relevant positive response for at least one of the dose groups occurs in at
least one strain with or without metabolic activation.
According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results. A test item producing neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the test points is considered non-mutagenic in this system.
- Statistics:
- a statistical evaluation of the results is not regarded necessary
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 uvrA
- 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'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The reported data of this mutagenicity assay shows that under the experimental conditions reported the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the strains used. Therefore, F 46 Black was considered non-mutagenic in the bacterial reverse mutation assay. - Executive summary:
Based on the results obtained in the present Ames test according to EU method B.13/14 and OECD guideline 471 the test item F 46 Black was not considered mutagenic.
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