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Diss Factsheets
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EC number: 427-670-0 | 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:
- 1 April 1998 - 8 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Lot/batch No.: 6090
Constituent 1
Method
- Target gene:
- Histidine gene in Salmonella typhimurium
Tryptophan gene in Escherichia coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix rat liver - Aroclor 1254
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:Dimethyl formamide
- Justification for choice of solvent/vehicle: not indicated
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl formamide
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9-mix
Migrated to IUCLID6: 3 µg/plate for TA100; 5µg/plate TA 1535; 2 µg/plate for WP2uvrA
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9-mix
Migrated to IUCLID6: 80 µg/plate for TA 1537
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9-mix
Migrated to IUCLID6: 0.2µg/plate for TA98
- Positive controls:
- other: non-mutagenic in the absence of metabolic enzymes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9-mix
Migrated to IUCLID6: 5 µg/plate for TA98
- Positive controls:
- other: non-mutagenic in the absence of metabolic enzymes
- Positive control substance:
- other: 2-aminoanthracene, 1 µg/plate for TA100; 2 µg/plate for TA 1535 and TA 1537; 10µg/plate for WP2uvrA
- Remarks:
- with S9-mix
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 µg/plate
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: 30 min
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 1^9 - 9.9^9 cells/ml
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER:
precipitation of the test substance - Evaluation criteria:
- The test substance should have induced a reproducible, dose-related and statistically (Dunnett's method of linear regression) Significant increase in the revertant count in at least one strain of bacteria. If a greater than twofold increase in revertant count is observed in two experiments then this is taken as evidence of a positive response.
- Statistics:
- Dunnett's method of linear regression
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
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- an amber-coloured precipitate was observed at 5000 µg/plate that did not prevent the scoring of revertant colonies
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- an amber-coloured precipitate was observed at 5000 µg/plate that did not prevent the scoring of revertant colonies
- Additional information on results:
- No toxicity was exhibited to any of the strains of bacteria used. An amber-coloured precipitate was observed at 5000 µg/plate, this did not prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation.
All positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test substance was considered to be non-mutagenic under the conditions of this test.
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.
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