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EC number: 604-612-4 | CAS number: 147900-93-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- of 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- of 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
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:
- other: essential amino acid requiring strains
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: essential amino acid requiring strain
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from male Sprague Dawley rats treated with phenobarbital and 5,6-benzoflavone for enzyme induction.
- Test concentrations with justification for top dose:
- Experiment 1 [each strain was tested without and with metabolic activation (-/+S9, respectively)]
Doses: 0; 5; 15; 50; 150; 500; 1500 and 5000 μg/plate
Experiment 2:
TA 98 (-/+S9): 0; 15; 50; 150; 500; 1500 μg/plate
TA 100 (-/+S9): 0; 50; 150; 500; 1500; 5000 μg/plate
TA 1535 (-/+S9): 0; 15; 50; 150; 500; 1500 μg/plate
TA 1537 (- S9): 0; 5; 15; 50; 150; 500 μg/plate
TA 1537 (+S9): 0; 15; 50; 150; 500; 1500 μg/plate
WP2uvrA (-/+S9): 0; 50; 150; 500; 1500; 5000 μg/plate - Vehicle / solvent:
- Ethanol
Justification for choice of solvent/vehicle:
Ethanol was a suitable vehicle for exposure to the test substance up to the maximum guideline recommended test substance concentration of of 5000 μg/plate.
Controlsopen allclose all
- Untreated negative controls:
- other: Sterility controls were included, i.e. tester strain free plates with soft agar, S9 mix, buffer, vehicle and/or test substance.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- without and with S9 mix
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide; 9-aminoacridine; 2-Nitrofluorene; 4-nitroquinoline-1-oxide.
- Remarks:
- Positive control substances for tests without metabolic activation (S9 mix). All of them are well established reference mutagens.
- Untreated negative controls:
- other: Sterility controls were included, i.e. tester strain free plates with soft agar, S9 mix, buffer, vehicle and/or test substance.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- without and with S9 mix
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene; Benzo[a]pyrene
- Remarks:
- Positive control substances for tests with metabolic activation (S9 mix). All of them are well established reference mutagens.
- Details on test system and experimental conditions:
- Standard Plate Incorporation Tests were performed in both experiments (Experiments 1 and 2) and both experiments were conducted without and with metabolic activation (S9 mix). Test procedures varied in that the proportion of S9 fraction in the S9 mix was 10% in Experiment 1 whereas 20% in Experiment 2.
In both experiments, precipitate was observed on all plates containing WS400151 at 5000 μg/plate.
The following positive controls were used to check mutability of the bacteria and activity of the S9 mix:
Without metabolic activation (S9 mix):
Sodium azide (CAS No. 26628-22-8):
- 2 μg/plate, dissolved in DMSO: - strains: TA 1535, TA 100
9-Aminoacridine (CAS No. 90-45-9):
- 50 μg/plate, dissolved in DMSO: - strain: TA 1537
2-Nitrofluorene (CAS No. 607-57-8):
- 2 μg/plate, dissolved in DMSO: - strain: TA 98
4-Nitroquinoline-1-oxide (CAS No. 56-57-5):
- 2 μg/plate, dissolved in DMSO: - strain: WP2 uvrA
With metabolic activation (S9 mix):
2-Aminoanthracene (CAS No. 613-13-8):
- 5 μg/plate, dissolved in DMSO: - strains: TA 1535, TA 100
- 10 μg/plate, dissolved in DMSO: - strain: WP2 uvrA
Benzo[a]pyrene (CAS No. 50-32-8):
- 5 μg/plate, dissolved in DMSO: - strains: TA 1537, TA 98 - Evaluation criteria:
- The test substance is considered to exhibit mutagenic activity in this assay if the following criteria are met:
A reproducible increase in revertant colony number, (i.e. at least twice for strains TA 100, TA 98 and WP2 uvrA and at least three times for strains TA 1535 and TA 1537 the concurrent vehicle controls), with some evidence of a positive dose-response relationship. Such positive response in at least one tester strain without or with metabolic activation (S9 mix.) is sufficient for concluding mutagenic activity.
A test substance is considered non-mutagenic in this test if:
Exposure to a test substance does not produce a reproducible increase in revertant colony numbers. - Statistics:
- The data were not statistically analysed. The study result was unequivocal.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- in both experiments (Experiment 1 and 2)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- except in TA 100. The lowest concentration at which toxicity was observed in any other TA strain was 500 µg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- in both experiments (Experiment 1 and 2)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- but only without metabolic activation and only at 5000 µg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- All sterility control plates were colony free. Hence the absence of microbial contamination of the S9 mix, buffer and test substance formulation was confirmed. Viability counts were satisfactory meeting the acceptance criteria.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: in both experiments (Experiment 1 and 2)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without and with metabolic activation (S9 mix)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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