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Diss Factsheets
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EC number: - | 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:
- 2014.09.15~2014.12.30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
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)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 0.015, 0.03, 0.06, 0.125, 0.25, 0.5, 1 µg/plate
- Vehicle / solvent:
- distilled water, DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Remarks:
- All strains with and without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(-5-nitro-2-furyl)-acrylamide
- Remarks:
- TA100, TA98, WP2 uvrA Without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 Without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(-5-nitro-2-furyl)-acrylamide
- Remarks:
- TA98 Without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene(2-AA)
- Remarks:
- All strains with S9 mix
- Details on test system and experimental conditions:
- 3.8.1 Selection of the test method
This test was carried out using the pre-incubation method under the presence and absence of S9 mix.
3.8.2 Pre-incubation Method
(1) For each treatment, 0.1 mL of the test substance solution, negative (solvent) control or positive control solution was added into a sterilized test tube.
(2) For assays in the absence of S9 mix, 0.5 mL of 0.1 mol/L sodium phosphate buffer (pH 7.4) was mixed and 0.1 mL of a bacterial suspension was added to this mixture.
(3) For assays in the presence of S9 mix, 0.5 mL of S9 mix was mixed and 0.1 mL of a bacterial suspension was added to this mixture.
(4) The mixture was incubated with gentle shaking (Shaking frequency: 120 times/minute) for 20 minutes at 37°C (pre-incubation).
(5) After pre-incubation, 2 mL of the molten top agar was added to this mixture and then poured onto a minimal glucose agar plate.
(6) After the overlaid agar had solidified, the plates were incubated for (48 ± 2) hours at 37°C.
3.8.3 Observation
Precipitation : After incubation for (48 ±2) hours, presence of precipitation on the agar plates was examined with the unaided eye.
Microbial toxicity : After incubation for (48 ± 2) hours, microbial toxicity was examined with a stereoscopic microscope.
3.8.4 Colony count
The colonies in each plate were counted with the unaided eye.
3.8.5 Number of plate
concentration range-finding test: 3 plate/dose
Main test: 3 plate/dose
3.8.6 Expression of data
The mean of the measured number of revertant colonies was calculated for the negative
(solvent) control, the positive control and the test substance treatments. The mean was
expressed by rounding to the first decimal place.
3.8.7 Sterility test
The sterility test was also performed, using one plate for each of the highest dose of test substance solution and the S9 mix used in the test.
(1) In the concentration range-finding test and main test, 0.1 mL of the highest dose of the test substance solution or 0.5 mL S9 mix was mixed with 2 mL of the molten top agar.
(2) The mixture was poured onto a minimal glucose agar plate.
(3) After the overlaid agar had solidified, the plates were incubated for (48 ± 2) hours at 37°C, and bacterial contamination was checked with the unaided eye.
3.8.8 Acceptable criteria of the test
The test was accepted as valid if all the following criteria were satisfied.
(1) The negative (solvent) control values (mean value) and the positive control values (mean value) were within the proper ranges calculated based on the historical data at the testing facility.
(2) The positive control values (mean value) show positive responses in the respective test strains, as evidenced by the number of revertant colonies being greater than 2-fold of the respective negative (solvent) control value.
(3) There are 4 or more doses giving no microbial toxicity and at least 5 analyzable doses.
(4) The highest dose in the main test is conducted up to the doses at which microbial toxicity was observed or 5000 μg/plate.
(5) The result of the sterility test indicates that there is no microbial contamination.
(6) There are no plates, which became invalid for measurement due to contamination or other unexpected situations. - Evaluation criteria:
- Test substance was judged to have mutagenicity (positive) when the test substance induced a dose-dependent increase in the number of the revertant colonies (mean value) to a level equal to or greater than 2-fold of the negative (solvent) control value (mean value) in each test strains either in the presence of absence of S9 mix and also when the dose-dependent increase was reproducible. Otherwise, the mutagenicity of the test substance was considered to be negative. No statistical analysis was performed with the test results in the present study.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
- valid
- Additional information on results:
- Main test
The results of the main tests were summarized in tables 4 ~ 5 and appendices 4 ~ 5. In the two main tests, growth inhibitions were observed at the dose of 1 μg/plate or more for TA98, WP2uvrA, and at the dose of 0.5 μg/plate or more for TA100 TA1535 and TA1537 in the absence and presence of S9 mix.
The number of revertant colonies from the test substance-treated group did not show an increase surface when compared to the negative control group. Precipitation was not observed on the agar plates at the any dose in the presence and absence of S9 mix.
Sterility test
Microbial contamination was not observed in the highest dose of test substance solution and S9 mix in the sterility test group in either the concentration range-finding tests or the main tests. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that Red 620 was not mutagenic (negative) under the conditions employed in the present study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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