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EC number: 485-420-6 | CAS number: 182918-16-7
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, OECD guideline conform, well documented, read across substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- 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
- Reference substance name:
- -
- EC Number:
- 440-520-9
- EC Name:
- -
- IUPAC Name:
- 440-520-9
Constituent 1
Method
- Target gene:
- His-: Salmonella typhimurium
Trp-: E. coli
Species / strain
- Species / strain / cell type:
- other: TA 1537, TA 98, TA1535, TA100, WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/p-Naphthoflavone induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Experiment I (plate incorporation test): 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II (preincubation test): 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see: "Details on test system"
- Details on test system and experimental conditions:
- Positive Control Substances:
Without metabolic activation:
Strains: TA 1535, TA 100
Name: sodium azide, NaN3
Supplier: SERVA, D-69042 Heidelberg
Catalogue No.: 30175
Purity: at least 99 %
Dissolved in: water deionised
Concentration: 10 µg/plate
Strains: TA1537,TA98
Name: 4-nitro-o-phenylene-diamine, 4-NOPD
Supplier: SIGMA. D-82041 Deisenhofen
Catalogue No.: N9504
Purity: > 99.9 %
Dissolved in: DMSO (MERCK. D-64293 Darmstadt; purity > 99 %)
Concentration: 10 µg/plate in TA 98. 50 µg/plate in TA 1537
Strains: WP2 uvrA
Name: methyl methane sulfonate. MMS
Supplier: Merck-Schuchardt, D-85662 Hohenbrunn
Catalogue No.: 820775
Purity: > 99.0 %
Dissolved in: water deionised
Concentration: 4 µl/plate
With metabolic activation:
Strains: TA 1535, TA 1537, TA 98. TA 100, WP2 uvrA
Name: 2-aminoanthracene, 2-AA
Supplier: SIGMA, D-82041 Deisenhofen
Catalogue No.: A 1381
Purity: 97.5 %
Dissolved in: DMSO (MERCK, D-64293 Darmstadt; purity > 99 %)
Concentration: 2.5 µg/plate, 10 µg/plate in strain WP2 uvrA - Evaluation criteria:
- The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data
- the positive control substances should produce a significant increase in mutant colony frequencies
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 ofthe 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 at 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:
- No statistical evaluation of the data is required.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium strains TA 1535, TA 1537, TA98, and TA 100, and the Escherichia coli strain WP2 uvrA.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see: "Additional information on results"
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In experiment I: toxic effects (below the factor of 0.5) were observed at higher concentrations in strain TA 1535 without S9 mix and in strains TA 1537 and TA 98 with and without S9 mix.
In experiment II: toxic effects were observed at the two highest concentrations in strain TA 1535 without S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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