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Diss Factsheets
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EC number: 471-170-5 | 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:
- 13 Aug to 12 Sept 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in 2005 according to OECD Method 471 and EU Annex V test B14 and in accordance with GLP. Study material is well characterized
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- 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:
- liquid
Method
- Target gene:
- four histidine-requiring strains and one tryptophan-requiring strain
Species / strain
- Species / strain / cell type:
- other: bacteria, other: Salmonella typhimurium: TA1535, TA1537, TA98, TA100 Escherichia coli: WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone/B-napthoflavone rat liver homogenate
- Test concentrations with justification for top dose:
- Preliminary toxicity (Range finding) experiment carried out at concentrations of 0., 0.15. 0.5, 1.5, 5, 15 ,50, 150, 500, 1500 and 5000 ug/plate . For experiment 1 concentrations (with & without metabolic activation) used: 50, 150, 500, 1500 and 5000 µg/plate . For experiment 2 the same doses were used as for test 1.
- Vehicle / solvent:
- acetone
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (vehicle controls used in parallel with the test material
- Positive controls:
- yes
- Remarks:
- other: 2-Aminoanthracene at 1 ug/plate for TA100, 2 ug/plate for TA1535 &TA1537 and 10 ug/plate for WP2uvrA with metabolic activation.
- Positive controls:
- yes
- Remarks:
- benzo(a)pyrene (5 ug/plate for TA98 with metabolic acti
- Positive controls:
- yes
- Remarks:
- N-ethyl-N-nitro-N-nitrosoguanidine (3 ug/plate for TA 100, 5 ug/plate for TA1535 and 2 ug/plate for WP2uvrA)
- Positive controls:
- yes
- Remarks:
- 9-aminoacridine (80 ug/plate for TA1537)
- Positive controls:
- yes
- Remarks:
- 4-nitroquinoline-N-oxide (0.2 ug/plate for TA98)
- Details on test system and experimental conditions:
- A toxicity range finding experiment was conducted with strain TA100 and WP2uvrA at ten concentrations plus negative (vehicle) controls in absence and in the presence of metabolic activation S-9. No evidence of toxicity was observed following this treatment and formulation and S9 mix were shown to be sterile. This test was acceptable and no evidence of toxicity was observed following this treatment. For experiment 1 five concentrations were assayed in triplicate against each tester strain with and without metabolic activation. Experiment 2 was performed using the same methodology. No evidence of toxicity was observed following this treatment. Negative and positive control treatments were included for all strains in both experiments. The mean numbers of revertant colonies on negative control plates were all acceptable.
- Evaluation criteria:
- Evaluation criteria: Acceptance criteria for validity of assay : the mean negative control counts fell within normal ranges, the positive control chemical induced clear increases in revertant numbers confirming discrimination between different strains and an active S-9 preparation, and no more than 5 % of the plates were lost through contamination or some other unforeseen event. Evaluation criteria: test article would be considered mutagenic if: the assay was valid, Dunnett's test gave significant response and the data set(s) showed a significant dose correlation and the positive responses described above were reproducible in atleast one strain of bacteria.
- Statistics:
- Mean and standard deviation of the plate counts for each treatment were determined
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- not specified
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- not specified
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate
- Species / strain:
- other: Salmonella typhimurium: TA1535, TA1537, TA98, TA100 Escherichia coli: WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- main test- experiment 1&2
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations: All positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9 mix were validated. The test substance caused no visible reduction in the growth of the bacterial lawn at any dose level. The test substance was, therefore, tested up to the maximum recommended dose of 5000 ug/plate. Precipitate (oily) was observed on the plates at equal to and greater than 1500 ug/plate.
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
No statistically significant increases in revertant colony frequency were observed in any of the bacterial strains at all dose levels with and without S9.
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