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EC number: 605-296-0 | CAS number: 162627-17-0
- 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
- 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 an internationally accepted technical guideline and in compliance with GLP in a contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- of 1997
- Deviations:
- yes
- Remarks:
- Occasional incubation temperature from 34.2°C to 39.9°C. In view of good growth and comparable results in all tests, study results were considered to be unaffected by this.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA102, TA1535, TA1537
- Additional strain / cell type characteristics:
- other: essential amino acid requiring strains
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver microsomal fraction (S9 mix), supplied by Molecular Toxicology, Inc., Boone, North Carolina, USA
- Test concentrations with justification for top dose:
- Preliminary toxicity test (only with TA100): 5.0, 12.5, 25, 50, 125, 250, 500, 1250, and 5000 μg/plate
Main Tests (Experiments 1 and 2, with all strains): 0.50, 5.0, 50, 500, and 5000 μg/plate
In addition, in several instances, 0.05 and 0.005 μg/plate levels were also assayed, but being all negative for mutagenicity these results in general were not reported. Only for the independent repeat experiment (Experiment 2) for TA98 (-S9) the results of the 0.05 µg/plate level were reported, because in this experiment no data were available for the 0.5 µg/plate concentration, as no background lawn was observed. - Vehicle / solvent:
- Ethanol
Justification for choice of solvent/vehicle: Outcome of solubility trials conducted at the testing laboratory.
Controls
- Untreated negative controls:
- yes
- Remarks:
- testing for spontaneous reversion and in some assays with TA100, TA102 and TA1535 mainly (-S9) water controls included
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 2-nitrofluorene, 9-aminoacridine, 2-aminoanthracene and mitomycin C.
- Details on test system and experimental conditions:
- Two independent assays (Plate Incorporation tests) were conducted (Experiments 1 and 2), each without and with metabolic activation (-/+ S9 mix)
METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS:
Preliminary toxicity test: Water and vehicle controls: all plating performed in duplicate; Test concentrations: all plating performed in triplicate.
Experiments 1 and 2: All test substance concentrations, vehicle controls and positive controls were plated in triplicate. On very few occasions single plates were not considered due to reduced background lawn.
PRECIPITATE:
In the main tests (Experiments 1 and 2) moderate precipitate was evident at 5000 µg/plate in all but one assays. Only in Experiment 2 with TA1535 (-S9 mix) precipitate was not recorded at 5000 µg/plate. In the preliminary toxicity test, precipitate was moderate in degree at 2500 µg/plate and moderat to heavy in degree 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: 1.5 μg/plate: - strains: TA 1535, TA 100
9-Aminoacridine: 75 μg/plate: - strain: TA 1537
2-Nitrofluorene: 2.0 μg/plate: - strain: TA 98
Mitomycin C: 0.5 μg/plate: - strain: TA 102
With metabolic activation (+S9 mix):
2-Aminoanthracene: 1.0 μg/plate: - strains: TA 98, TA 100, TA 102, TA 1535, TA 1537
DURATION
Incubation time: 48 h at approximately 37 +/- 2 degrees. Occasional incubation temperature from 34.2°C to 39.9°C. In view of good growth and comparable results in all tests, study results were considered to be unaffected by this.
DETERMINATION OF CYTOTOXICITY
Cytotoxicity was tested in the preliminary assay with a single strain, TA100, in the presence and absence of metabolic activation.
TESTER STRAIN GENOTYPE CONFIRMATION
Genetic markers, such as histidine/biotin requirement, crystal violet sensitivity, ampicillin resistance, ultra violet sensitivity, tetracycline resistance and spontaneous reversion rates of the cultures to histidine independence have been checked in the testing laboratory. Each strain demonstrated the strain genotypes expected. In addition cell titres of each strain were measured at use. - Evaluation criteria:
- A concentration was considered toxic if one or both of the following criteria were met:
1) a reduction greater than 50% in the mean number of revertants per plate as compared to the mean vehicle control value. This reduction hasd to be accompanied by an abrupt dose-dependent drop on the revertant count.
2) A reduction observed in the background lawn.
The test substance was considered positive in the assay when:
1) statistically significant dose-related increase in the mean number of revertants for at least one tester strain, over a minimum of two test concentrations. Data sets for strains TA98, TA100 and TA102 were considered positive if the mean number of revertants at the peak of the dose-response was two times (or greater) than the mean solvent control values. Data sets for strains TA1535 and TA1537 were considered positive if the mean number of revertants at the peak of the dose-response was three times (or greater) than the mean solvent control values. - Statistics:
- Not specified.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 102, TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- in both experiments (Experiment 1 and 2)
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- In all but one incidence, precipitate moderate in degree at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- There was no evidence of reproducible cytotoxicity at any of the concentrations tested.
Positive controls were considered to be valid as in general their revertant colony number values were more than threefold higher than those of concurrent vehicle controls. - 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)
In both main experiments, the test material was found to be non-mutagenic for all of the tested Salmonella strains, TA98, TA100, TA102, TA1535 and TA1537, both without and with metabolic activation.
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