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Diss Factsheets
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EC number: 280-489-7 | CAS number: 83567-04-8
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From November 12, 1999 to December 04, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- red powder
Constituent 1
- Specific details on test material used for the study:
- Purity: 52%
Concentration of stock solution in deionized water: 50 mg/mL
Method
- Target gene:
- Histidine and tryptophan
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: deficient in lipopolysaccharide layer and in DNA excision repair system
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: defective in the uvrA system of DNA repair
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 fraction (rat liver homogenate)
- Test concentrations with justification for top dose:
- Plate incorporation test: 1. 0, 50, 160, 500, 1600 and 5000 µg/plate
Repeat plate incorporation test: 2. 0, 50, 160, 500, 1600, 2500 and 5000 µg/plate - Vehicle / solvent:
- Deionized water
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- deionized water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 1-methyl-3-nitro-1-nitrosoguanidine and 2-aminoanthracene
- Details on test system and experimental conditions:
- To 2 mL of molten top agar in a sterile test-tube, 0.1 mL of the tester strain culture, graded quantities of the test substance in 0.1 mL solution and, for the S-9 series, 0.5 mL of S-9 Mix were added. The contents of the test tube were rapidly mixed and poured onto the surface of previously prepared minimal agar plates with Vogel-Bonner E mixture. The plate were incubated upside down at 37°C for 2 d, after which the number of revertants colonies appearing was counted.
In addition, sterility of the test medium, solubility of the test substance and toxicity to the test strains were evaluated. - Evaluation criteria:
- Doubling of the spontaneous mutation rate (control) and dose-related increase in the mean number of revertants
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- in both tests
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- All positive controls produced significant increases in the number of revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was mutagenic to Salmonella typhimurium with and without metabolic activation (Ames test).
- Executive summary:
A study was conducted to determine the mutagenic potential of the substance according to OECD Guideline 471, EU Method B13/14 and US EPA OPPTS 870.5100, in compliance with GLP. Four strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and Escherichia coli strain WP2uvrA were exposed to the test substance at concentrations of 0 to 5000 µg/plate with or without metabolic activation (S-9 Mix) for 48 h. Negative and positive controls were valid. The test substance induced mutagenic activity in the strain of Salmonella typhimurium TA 1535 both under the presence as well as absence of metabolic activation. The number of revertants was greater than twice the number of spontaneous mutations. Mutagenicity was negative in all other strains tested. Under the study conditions, the substance was considered to be mutagenic with and without metabolic activation (Stammberger, 1999).
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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