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EC number: 465-100-2 | 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
- 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:
- 2003
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch number: 022401
Constituent 1
Method
- Target gene:
- The actual batch of the strains was tested for ampicillin res.stance (TA102: ampicillin/tetracycline resistance), UV-sensitivity and sensitivity against crystal violet, for spontaneous mutation frequencies and for sensitivities against the positive control substances in September 2000.
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA97a, TA98, TA100, TA102, and TA1535 .
- Metabolic activation:
- with and without
- Metabolic activation system:
- The microsomal fraction of homogenised livers of female Sprague Dawley rats treated once with 500 mg/kg of Aroclor 1254 was used (S9 mix).
- Test concentrations with justification for top dose:
- The concentrations for the first experiment were set according to a preliminary toxicity test.
The test substance was only slightly toxic at 5000 µg/plate. Therefore this concentration was chosen as highest concentration, which is the limit concentration according to the guidelines. Each of the other 4 concentrations was 1/3 of the preceding one.
The number and intervals of the concentrations are in accordance with the guidelines . - Vehicle / solvent:
- Solvent: Dimethylsulfoxide.
- Details on test system and experimental conditions:
- The exposure was performed according to the 'Plate lncor oration Assay', in which bacteria, test substance (and microsomes) are in contact on the plat13 without preceding incubation in the liquid state. The number of viable cells in the overnight-cultures is in the range of 2 x 108 cells per ml.
For each sample the following solutions were combined:
• 0.1 ml of the overnight culture of the bacteria,
• 0.5 ml of S9-mix (or phosphate buffered saline for samples without metabolic activation),
• 0.1 ml of the appropriate test- or reference substance solution and
• 2 ml of top agar.
The combined solutions were mixed and spread over a pla1e with minimal agar (9 cm diameter). After the top agar had solidified, the plates were incubated at 37 °C until the colonies were visible (2 days).
The plates with less than about 50 revertant colonies, i.e. tile plates of TA98 and TA1535 with the exception of the positive controls, were counted vi ;ually by marking the colonies with a felt tipped pen. The other plates were photographed with a video camera and the picture files were scanned for colonies by a computer program. - Evaluation criteria:
- The criteria for a positive result are:
A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations:
• For the strains with a low spontaneous revertant rate i.e. TA98 and TA1535: The 2½ fold of the amount of the spontaneous revertants.
• For the strains with a high spontaneous revertant rate i.n. TA97a, TA100 and TA102: The
1 2/3 fold of the amount of the spontaneous revertants.
These threshold values were derived from the variations in the control samples of our historic data of the Ames test - Statistics:
- Means and standard deviations were calculated for the number of mutants in every concentration group.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: TA97a, TA98, TA100, TA102 and TA1:535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight toxicity was noted only in the 5000 µg/plate samples without metabolisation, resulting in a reduced bacterial background lawn.
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: TA97a, TA98, TA100, TA102 and TA1:535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
In none of the concentrations and in none of the strains
used a relevant increase of the mutation frequency was
observed. Metabolic activation did not change this result.
Results were reproduced in an independent experiment. - Remarks on result:
- other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- According to these results, "STl571 F8" is not mutagenic in the Ames test with the strains of Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 up to 5000 µg/plate, which is the limit concentration for this kind of test.
The test result was negative with metabolic activation and negative without metabolic activation
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