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EC number: 259-452-4 | CAS number: 55039-14-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Justification for read across is detailed in the report attached to the IUCLID section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Justification for read across is detailed in the report attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only four tester strains tested; no tester strain to detect cross-linking mutagens was included
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- None
- Target gene:
- Histidine for Salmonella
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Strain Type of MutationS. typhimurium TA 100 base-pair substitutionS. typhimurium TA 1535 base-pair substitutionS. typhimurium TA 98 frame-shiftS. typhimurium TA 1537 frame-shift
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat-liver post mitochondrial supernatant (S9 fraction)
- Test concentrations with justification for top dose:
- 0.2 to 2000 µg
- Vehicle / solvent:
- bidistilled water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: strains TA 1535 and TA 100 - MNNG, for Strain TA 98 - Daunomycine and for strain TA 1537 - 9-aminoacridine; with S9: 2-anthramine was used for all the strains
- Details on test system and experimental conditions:
- INDUCTION OF RAT LIVER ENZYMESThree male Sprague-Dawley rats weighing approximately 200 grams were given an i.p. injection of Aroclor 1254 (Monsanto) in peanut oil at a dose of 500 mg/kg.Five days after the injection, the rats were anaesthetized with ether, decapitated and the livers removed in a sterile manner. The livers were homogenizedin twice their volume of sterile 0.15 M KCl, pooled together and centrifuged for 15 min at 9000 xg (Beekman refrigerated ultracentrifuge). The supernatant(termed the S-9 fraction) was aliquoted into sterile tubes and frozen at -70°C.TEST SUBSTANCE AND CONCENTRATIONSA sample of the product FAT 20013/B (a brown dyestuff) was tested in S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels: 0.2, 2, 20, 200 and 2000 (jg (or nl) per Petri dish. The test substance was dissolved in distilled water and every concentration was tested in triplicate.
- Rationale for test conditions:
- None
- Evaluation criteria:
- The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate and a dose-effect relationship.
- Statistics:
- None
- Key result
- Species / strain:
- other: For strains TA 1535, TA 1537 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- None
- Conclusions:
- It is concluded that the metabolites exerted a mutagenic action on strain S. typhimurium TA 98.
- Executive summary:
The study was performed to investigate the potential of Fteh Similar substance 01 to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100. The assay was performed in two independent experiments both with and without liver microsomal activation.
Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the product was found mutagenic for S. typhimurium strain TA 98. No mutagenic effect was observed with the strains TA 1535, TA 1537 and TA 100. With TA 98, the evidence of mutagenicity existed at 2000 µg in the presence of S-9 mix, and at 200 µg and 2000 µg of product per Petri dish without S-9 mix. In the absence of S-9 mix, at 2000 µg of product per plate, a toxic effect was noted with a dispersed background lawn. A complete disappearance of the background lawn was observed with the strains TA 1535 and TA 1537 at 2000 µg in the absence of S-9 mix.
It is concluded that the metabolites of the substance exerted a mutagenic action on strain S. typhimurium TA 98.
None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only four tester strains tested; no tester strain to detect cross-linking mutagens was included
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Similar substance 01 of Acid Black 213
- IUPAC Name:
- Similar substance 01 of Acid Black 213
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- None
Method
- Target gene:
- Histidine for Salmonella
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Strain Type of MutationS. typhimurium TA 100 base-pair substitutionS. typhimurium TA 1535 base-pair substitutionS. typhimurium TA 98 frame-shiftS. typhimurium TA 1537 frame-shift
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat-liver post mitochondrial supernatant (S9 fraction)
- Test concentrations with justification for top dose:
- 0.2 to 2000 µg
- Vehicle / solvent:
- bidistilled water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: strains TA 1535 and TA 100 - MNNG, for Strain TA 98 - Daunomycine and for strain TA 1537 - 9-aminoacridine; with S9: 2-anthramine was used for all the strains
- Details on test system and experimental conditions:
- INDUCTION OF RAT LIVER ENZYMESThree male Sprague-Dawley rats weighing approximately 200 grams were given an i.p. injection of Aroclor 1254 (Monsanto) in peanut oil at a dose of 500 mg/kg.Five days after the injection, the rats were anaesthetized with ether, decapitated and the livers removed in a sterile manner. The livers were homogenizedin twice their volume of sterile 0.15 M KCl, pooled together and centrifuged for 15 min at 9000 xg (Beekman refrigerated ultracentrifuge). The supernatant(termed the S-9 fraction) was aliquoted into sterile tubes and frozen at -70°C.TEST SUBSTANCE AND CONCENTRATIONSA sample of the product FAT 20013/B (a brown dyestuff) was tested in S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels: 0.2, 2, 20, 200 and 2000 (jg (or nl) per Petri dish. The test substance was dissolved in distilled water and every concentration was tested in triplicate.
- Rationale for test conditions:
- None
- Evaluation criteria:
- The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate and a dose-effect relationship.
- Statistics:
- None
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: For strains TA 1535, TA 1537 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the metabolites exerted a mutagenic action on strain S. typhimurium TA 98.
- Executive summary:
The study was performed to investigate the potential of Fteh Similar substance 01 to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100. The assay was performed in two independent experiments both with and without liver microsomal activation.
Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the product was found mutagenic for S. typhimurium strain TA 98. No mutagenic effect was observed with the strains TA 1535, TA 1537 and TA 100. With TA 98, the evidence of mutagenicity existed at 2000 µg in the presence of S-9 mix, and at 200 µg and 2000 µg of product per Petri dish without S-9 mix. In the absence of S-9 mix, at 2000 µg of product per plate, a toxic effect was noted with a dispersed background lawn. A complete disappearance of the background lawn was observed with the strains TA 1535 and TA 1537 at 2000 µg in the absence of S-9 mix.
It is concluded that the metabolites of the substance exerted a mutagenic action on strain S. typhimurium TA 98.
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