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EC number: 274-040-4 | CAS number: 69563-51-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000!32/EC, L 1362000. Anllex 4D", dated May 19, 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines: "Kanpoan No. 287 -- Envlrorlment Protection Agency" Eisei No. 127 -- Ministry 01 Health & Welfare" "Heisei 09/10131 Kikyoku No. 2 -- Ministry of In!erna!ional Trade & Industry"
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide
- EC Number:
- 274-040-4
- EC Name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide
- Cas Number:
- 69563-51-5
- Molecular formula:
- C21H16N2O5S
- IUPAC Name:
- N-(4-amino-3-methoxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)benzenesulfonamide
- Test material form:
- other: solid
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 09979EB5
- Expiration date of the lot/batch: March 14, 2011
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Method
- Target gene:
- Salmonella typhimurium histidine (his) and the E. coli tryptophan (trp)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mixType and composition of metabolic activation system:
- source of S9 : rat liver
- method of preparation of S9 mix:
The S9 is prepared from 8 - 12 weeks old male Wistar Hanlbm rats, weight approx, 220 - 320 g induced by applications of 80 mglkg b.w. Phenobarbital Lp (Desitin; D-22335 Hamburg) and ß-Naphthoflavone p,o. (Aldrich, D-89555 Steinheim) each on three consecutive days, The livers are prepared 24 hours after the last treatment The S9 fractions are produced by dilution of the liver homogenate with a KCI solution (1+3) followed by centrifugation at 9000 g. Aliquots of the supenatant are frozen and stored in ampoules at -80 °C. Small numbers of Ihe ampoules can be kept at -20 °C for up to one week. Each balch of S9 mix is routinely tested wilh 2-aminoanthracene as well as benzo(a}pyrene. - Test concentrations with justification for top dose:
- 3; 10; 33; 100: 333; 1000; 2500; and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 1537,TA98; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535, TA 1537. TA 98, TA 100, WP2 uvrA ; With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- 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 al 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.
- Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- 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
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolite activation. A moderate but dose dependent increase in revertant colony numbers was observed following treatment with FAT 360341G in experiment I in strain TA 1537 in the absence of metabolite activation (S9 mix) and in strain TA 98 in the presence of metabolite activation. In strain TA 1537 the threshold of three times the number of the corresponding solvent control was exceeded at 5000 µg/plate. In strain TA 98 the required threshold of twice the number of the corresponding control was reached at 2500 µg/plate and exceeded at 5000 µg/plate. No comparable increase of the mutation frequency occurred in the other strains. A confirmatory experiment was performed under identically conditions 10 reproduce this minor increase. The results of the confirmatory confirmed the minor increase in the number of the revertants in strain TA 1537 without 89 mix and in strain TA 98 with S9 mix. In this experiment in strain TA 1537 the threshold of three limes the number of the corresponding solvent control was exceeded at 5000 µg/plate. In strain TA 98 the required threshold of twice the number of the corresponding control was reached at 5000 µg/plate.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- FAT 36034/G is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
This study was performed to investigate the potential of FAT 36034/G to induce gene mutations in the plate incorporation test (experiment I) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA as per OECD 471 guideline. The assay was performed 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 l and l a: 3, 10; 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 independent experiments. No toxic effects, evident as a reduction in the number of revertants, occurred in the test groups with and without metabolic activation. A moderate but dose dependent increase in revertant colony numbers was observed following treatment with FAT 360341G in experiment in strain TA 1537 in the absence of metabolic activation (S9 mix) and in strain TA 98 in the presence of metabolic activation. In strain TA 1537 the threshold of three times the number of the corresponding solvent control was exceeded at 5000 µg/plate. In strain TA 98 the required threshold of twice the number of the corresponding control was reached at 2500 ug/plate and exceeded at 5000 µg/plate, No comparable increase of the mutation frequency occurred in the other strains. A confirmatory experiment was performed under identical conditions to reproduce this minor increase. The results of the confirmatory confirmed the minor increase in the number of the revertants In strain TA 1537 without S9 mix and in strain TA 98 with S9 mix. In this experiment in strain TA 1537 the threshold of three times the number of the corresponding solvent control was exceeded at 5000 µg/plate. In strain TA 98 the required threshold of mice the number of the corresponding control was reached at 5000 µg/plate. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did induce gene mutations by frame shifts in the genome of the strains TA 1537 (without S9 mix) and TA 98 (with S9 mix). Therefore, FAT 36034/G is considered to be mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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