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EC number: 919-701-6 | CAS number: 503157-00-4
- 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:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline 471 and in accordance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
Method
- Target gene:
- Histidine auxotrophic strains of Salmonella typhimurium: TA98, TA100, TA1535 and TA1537.
Tryptophan auxotrophic strain of Escherichia coli: WP2uvrA (pKM101).
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium: TA98, TA100, TA1535 and TA1537; Escherichia coli: WP2uvrA (pKM101).
- Details on mammalian cell type (if applicable):
- None
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- -Initial Mutation Assay
(a) 50, (b) 158, (c) 500, (d) 1581 and (e) 5000 µg/plate
-CONFIRMATORY MUTATION ASSAY
(a) 100, (b) 266, (c) 707, (d) 1880 and (e) 5000 µg/plate. - Vehicle / solvent:
- Sterile Water
Controls
- Untreated negative controls:
- yes
- Remarks:
- Sterile water
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2-Aminoanthracene, 2-Nitrofluorene, Sodium azide, 9-aminoacridine, 4-Nitroquinoline-1-oxide
- Positive control substance:
- not specified
- Remarks:
- None
- Details on test system and experimental conditions:
- Following strains of bacteria accepted under OECD for the assessment of point gene mutation were used:
Histidine auxotrophic strains of Salmonella typhimurium: TA98, TA100, TA1535 and TA1537.
Tryptophan auxotrophic strain of Escherichia coli: WP2uvrA (pKM101). - Evaluation criteria:
- To determine a positive result, there should be a dose related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of the test item either in the presence or absence of the metabolic activation system.
The test will be judged positive, if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value for strains TA98, TA100 and WP2uvrA (pKM101) or equal to or greater than 3 times the mean vehicle control value for strains TA1535 and TA1537.
An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited. A response will be evaluated as negative, if it is neither positive nor equivocal. - Statistics:
- None
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium: TA98, TA100, TA1535 and TA1537; Escherichia coli: WP2uvrA (pKM101).
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not specified
- Additional information on results:
- None
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
All criteria for a valid study were met as described in the study plan. It is concluded that the test item, FAT 40866/A TE, was not mutagenic in this bacterial reverse mutation test up to the regulatory-required top dose of 5000 µg/plate under the conditions of testing employed. - Executive summary:
The test item, FAT 40866/A TE was tested for its mutagenic potential in the bacterial reverse mutation assay. The study was conducted using TA98, TA100, TA1535 and TA1537 strains of Salmonella typhimurium and WP2uvrA (pKM101) strain of Escherichia coli in three phases, a preliminary toxicity test, an initial mutation assay and a confirmatory mutation assay. The bacterial tester strains were exposed to the test item in the presence and absence of metabolic activation system (S-9 fraction prepared from Aroclor 1254 induced rat liver).
FAT 40866/A TE is soluble in sterile water (SW) at the required concentration of 50 mg/mL and was found to be stable in SW for 24 hours at room temperature at the concentration levels of 500 µg/mL and 50000 µg/mL.
In a preliminary toxicity test for the selection of test doses for the mutation assay, FAT 40866/A TE did not precipitate the basal agar plates at any of the tested doses.FAT 40866/A TE did not cause toxicity to the tester strain up to the top dose of 5000 µg/plate either in the presence or absence of metabolic activation, as the intensity of the bacterial background lawn as well as the number of revertant colonies were comparable to the SW control plates. Based on these observations, it was decided to test up to 5000mg/plate in the initial as well as the confirmatory mutation assay both in the presence and absence of metabolic activation.
In the initial mutation assay,FAT 40866/A TE was exposed in triplicate to 50, 158, 500, 1581 and 5000mg/plate test doses in the presence and absence of metabolic activation using direct plate incorporation procedure. In the confirmatory mutation assay,FAT 40866/A TE was exposed in triplicate to 100, 266, 707, 1880 and 5000mg/plate test doses in the presence and absence of metabolic activation using pre-incubation procedure. The vehicle control (SW) and the appropriate positive controls were tested simultaneously. The mean and standard deviation of numbers of revertant colonies were calculated for each test dose and the controls for all the tester strains.
The results of the study from both the initial and confirmatory mutation assay showed that,FAT 40866/A TE did not show any positive mutagenic response at any of the tested doses either in the presence or in the absence of metabolic activation. Under identical test conditions, there was a more than 3-fold increase in the mean numbers of revertant colonies in the positive controls, demonstrating the sensitivity of the assay procedure used.
The results of the concentration analysis of the dose formulation samples of both the initial and confirmatory mutation assays confirmed that the top dose level of 5000µg/plate was achieved in both assays and the results support the validity of the study conclusion.
The study indicated that FAT 40866/A TE was not mutagenic in this Bacterial Reverse Mutation Assay up to the regulatory-required top dose of 5000mg/plate, under the conditions of testing employed.
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