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EC number: 268-544-3 | CAS number: 68123-13-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Mutation study was performed on Salmonella typhimurium strain TA1535 to evaluate the mutagenic nature of the test compound Basic Blue 99
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- Salmonella typhimurium strains TA1535
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- With and without S9 metabolic activation system
- Test concentrations with justification for top dose:
- 4 to 2500 μg/plate
- Vehicle / solvent:
- No data
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- no data
- Details on test system and experimental conditions:
- Details on test system and conditionsMETHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period: No data available- Exposure duration: No data available- Expression time (cells in growth medium): No data available- Selection time (if incubation with a selection agent): No data available- Fixation time (start of exposure up to fixation or harvest of cells): No data availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: No data availableDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No data availableOTHER EXAMINATIONS:- Determination of polyploidy: No data available- Determination of endoreplication : No data available- Other:OTHER: No data available
- Evaluation criteria:
- Increase in the revertants/plate
- Statistics:
- No data available
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data available
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Bacterial tester strain used
- Conclusions:
- Interpretation of results (migrated information):negative Negative (with and without)Basic Blue 99 failed to induce reverse mutations in the presence and absence of S9 in strains TA1535 and hence is a non-mutagenic in vitro.
- Executive summary:
Mutation study was performed onSalmonella typhimuriumstrain TA1535 to evaluate the mutagenic nature of the test compound Basic Blue 99 with and without activation. Sodium azide was used as a positive control.
Basic blue was found to be non-mutagenic in strains TA1535 with and without S9 metabolic activation.
According to the CLP classification, the test material Basic Blue 99 does not classify as a mutagen in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In vitro gene toxicity:
In a study conducted by American College of Toxicology (2007), in vitro gene toxicity was evaluated in Salmonella typhimurium strain TA1535 by using Basic Blue 99 with and without activation. Basic blue was found to be non-mutagenic in strains TA1535 with and without S9 metabolic activation. Therefore, Basic blue 99 did not induce DNA repair synthesis and hence is a non mutagen.
In the above similar reference, in vitro bacterial mutagenicity was carried out on E. coli strain 343/113 by using Basic Blue 99 in the concentrations of 1, 10, and 100μg/ml and a volume of 0.1 ml in a dark place at 37⁰C for 2 h. Cells were spread over four selected media and incubated for 20 to 72 h. Cells were counted and analyzed for reverse mutations of arg− to arg+ and nad− to nad+, forward mutations of 5-methyl-dl-trytophan-sensitivity to MT resistance, and forward and reverse mutations of gal Rs 18 to gal+. No mutant colonies were observed. Therefore, Basic blue 99 is non mutagenic in the E. coli strain 343/113.
In the above similar reference, in vitro structural chromosome aberrations in V79 cells of the male Chinese hamster in vitro with and without metabolic activation were assessed by using Basic Blue 99 in dimethylsulfoxide for 24 hours at 0, 0.1, 0.3, 0.5, 1.0, 2.5, 3.0, 5.0, or 10.0 μg/ml without S9 and for 2 h at 3, 10, 25, 30, 50, 100, 125, 150, or 250 μg/ml with S9. Basic Blue 99 did not induce an increase of thioguanine-resistant clone growth in cultured V79 Chinese hamster cells and hence, is a non mutagen.
In the above similar reference, in vitro DNA repair in rat hepatocytes in unscheduled DNA synthesis (UDS) assay in two replicate studies by using Basic Blue 99 in the concentration of 1.00, 3.33, 10.00, 33.33, and 100.00 μg/ml and incubated for 3 h. UDS was determined using liquid scintillation counting. A reduction in the incorporation of radioactivity occurred at 33.33 and 100.00 μg/ml in experiment I, which indicated weak toxicity. Concentrations higher than 100.00 μg/ml were very toxic. However, the incorporation of thymidine into rat hepatocytes was not dose related in either experiment. Therefore, Basic blue 99 did not induce DNA repair synthesis and hence is a non mutagen.
According to the CLP classification, the test material Basic Blue 99 (CAS no 68123-13-7) does not classify as a mutagen in vitro.
Justification for selection of genetic toxicity endpoint
Available study is of klimisch 2 and the quality of data is good
Justification for classification or non-classification
Basic Blue 99 (CAS no 68123-13-7) does not classify as a mutagen in vitro on the basis of CLP classification
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