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EC number: 701-175-2 | 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
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- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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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
- 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
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- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
- Target gene:
- not reported
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 from rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 20 - 2000 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: standard solvent
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2-anthramine, 2-nitrofluorene, sodium azide, and 9-aminoacridine
- Positive control substance:
- no
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 10-hr
- Exposure duration: 72 hours
- Expression time (cells in growth medium): 10e8 to 10e9 cells per mL
- Selection time (if incubation with a selection agent): 72 hours
SELECTION AGENT (mutation assays): not reported
SPINDLE INHIBITOR (cytogenetic assays): not reported
STAIN (for cytogenetic assays): not reported
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: elimination of a uniform background lawn
- Evaluation criteria:
- A mutagenicity assay is considered valid if the following conditions are met. First, the spontaneous reversion rate, with and without metabolic activation, must be reasonably consistent with the expected range for the strain being used. Second, the positive control materials must elicit a positive response. And third, strains must maintain characteristics, i.e., nutritional requirements, crystal violet sensitivity and ampicillin resistance. A test article is considered positive (mutagenic) if it elicits in independent assays a number of revertants per plate at least 2 times that observed in the solvent control (background). A response that does not meet this criteria but elicits a potential biologically significant response (e.g., a dose related increase in revertants per plate over 3 concentrations) is considered as equivocal response and requires further evaluation. A test article is considered negative (non-mutagenic) if the criteria for a positive assay were not met and the test article was tested up to 2,000 mg/plate or the limit of solubility or toxicity, whichever was lower. Toxicity is defined as the elimination of a uniform background lawn.
- Statistics:
- Statistical methods beyond the calculation of the mean and standard deviation are not considered necessary for the onterpretation of this study.
Results and discussion
Test results
- 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:
- cytotoxicity
- Remarks:
- 2000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: the test article did precipitate
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: In 1984 (see IUCLID section 7.6.1, record IUC4#1), the test material was reported to be mutagenic in strain 1535. However, in that study, the test agent did not induce a dose related increase in mutation frequency. Rather, the sporadic positive response observed was based upon a statistical increase in mutation frequency compared to the negative controls. In contrast, our current criteria for a mutagenic response is based upon a two-fold or greater increase in mutation frequency compared to the negative controls. Because the marginal response observed in the 1984 study may not be biologically meaningful, the assay was repeated according to our current test system.
COMPARISON WITH HISTORICAL CONTROL DATA: not reported
ADDITIONAL INFORMATION ON CYTOTOXICITY: none - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Salmonella typhimurium tester strains TA98, TA100, TA1535, TA1537
Any other information on results incl. tables
FREQUENCY OF EFFECTS: The test article did not induce an increase in revertants when compared to solvent controls.
Applicant's summary and conclusion
- Conclusions:
- Negative
- Executive summary:
The test material was evaluated for mutagenic activity in the Salmonella typhimurium gene mutation assay (Ames test). Tester strains were TA98, TA100, TA1535 and TA1537 in the presence and absence of a metabolic activation system (S-9 liver fraction from Aroclor 1254 induced rats). Dimethyl sulfoxide (DMSO) was used as the solvent for the test article and as the solvent control. In the presence of metabolic activation, 2 -anthramine was used as the positive control for all strains. In the absence of metabolic activation, the positive controls used were: 2 -nitrofluorene (TA98), sodium azide (TA100 and TA1535), and 9 -aminoacridine (TA1537). The test article was evaluated at concentrations ranging from 20 to 2000 ug/plate (all concentrations were based in the compound as received) and the number of revertants was determined.
The test article did not induce an increase in revertants when compared to solvent controls. This was true for all tester strains both with and without metabolic activation. Toxicity was observed in all strains, both without and with metabolic activation at 2000 ug/plate.
Under the conditions of this study, the test material is not mutagenic in the Salmonella gene mutation assay.
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