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EC number: 404-110-3 | 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: according to guideline (OECD TG 471), and to GLP; but using a different set of tester strains
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
- Reference Type:
- other: 1st Amendment to report No 89.1482
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- ; according to OECD 471 but different set of tester strains used
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction from Aroclor 1254 induced male Sprague Dawley rats
- Test concentrations with justification for top dose:
- Experiment 1: 0, 4, 20, 100, 500, 2500 and 10000 µg/plate
Experiment 2: 0, 4, 20, 100, 500, 2500 and 5000 µg/plate - Vehicle / solvent:
- - DMSO (test material)
- vehicle used for positive controls not stated
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA 100, TA 1535), 9-aminoacridine (TA 1537), 2-nitrofluorene (TA 98, TA 1538)
- Remarks:
- without metabolic acivation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: benzo[a]pyrene (all strains), 2-aminoanthracene (all strains)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period:
- Exposure duration:48-72 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48-72 h
NUMBER OF REPLICATIONS: two independent experiments were performed in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: microscopic inspection of bacterial lawn; reduced rate of spontaneously occuring colonies as well as visible thinning of the bacterial lawn were used as indicator for toxicity - Evaluation criteria:
- not documented
- Statistics:
- not performed
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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The test item precipitated at concentrations >/= 500 µg/plate.
In the first experiment a slight but not reproducible increase in the strain TA 1538 was observed in the two highest dose groups (mean values: 13, 12, 16, 18, 18, 27, 26 colonies per plate at 0, 4, 20, 100, 500, 2500, and 10000 µg/plate, respectively). - 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
Under the conditions of this study the test substance was not mutagenic in bacteria in concentrations up to 10000 µg/plate with and without metabolic activation. - Executive summary:
The mutagenicity of the test item was examined in the bacterial strains TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium in a study according to OECD guideline 471 and GLP (but using a different set of tester strains). The mutagenicity studies were conducted in two independent experiments in the absence and in the presence of a metabolizing system derived from S9 liver homogenate of Aroclor 1254-induced male Sprague-Dawley rats. Test concentrations were 0, 4, 20, 100, 500, 2500 and 10000/5000 (experiment 1/experiment 2) µg/plate. Visible precipitation of the test compound on the plates has been observed at 500 µg/plate and above. Control plates with solvent showed that the number of spontaneous revertant colonies was similar to that described in the literature. The test compound proved to be not toxic to the bacterial strains. In the absence or presence of the metabolic activation system the test compound did not cause a significant or a dose dependent increase in the number of revertants in any of the bacterial strains. All the positive control compounds gave the expected increase in the number of revertant colonies, indicating the sensitivity of the test system and the appropriate activity of the S9 mix. It can be stated that the test item is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.
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