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EC number: 274-641-1 | CAS number: 70516-41-5
- 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
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- 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
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- Endpoint summary
- Stability
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 23 January to 6 March 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study undertaken at GLP accredited laboratory to internationally accepted guidelines. The restriction is due to the use of the read across approach: the test was performed not with S-205 but with Black 400, a substance which has been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- ODB-2
- IUPAC Name:
- ODB-2
- Reference substance name:
- Black 400
- IUPAC Name:
- Black 400
- Reference substance name:
- 89331-94-2
- EC Number:
- 618-263-0
- Cas Number:
- 89331-94-2
- IUPAC Name:
- 89331-94-2
- Details on test material:
- - Name of test material (as cited in study report): ODB-2
- Physical state: White powder
- Analytical purity: 99% minimum
- Lot/batch No.: 8A-24433-10
- Expiry date of the lot/batch: October 1991
- Storage condition of test material: Room temperature in the dark
- Molecular formula (if other than submission substance): C35 H36 N2 O3
- Molecular weight (if other than submission substance): 532.7
- Smiles notation (if other than submission substance): CCCCN(CCCC)c6ccc5c(Oc2cc(C)c(Nc1ccccc1)cc2C54OC(=O)c3ccccc34)c6
- InChI: InChI=1/C35H36N2O3/c1-4-6-19-37(20-7-5-2)26-17-18-29-33(22-26)39-32-21-24(3)31(36-25-13-9-8-10-14-25)23-30(32)35(29)28-16-12-11-15-27(28)34(38)40-35/h8-18,21-23,36H,4-7,19-20H2,1-3H3
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Thymidine kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 0.5, 1, 5, 10, 15, 30, 40, 50 µg / ml
Mutation tests: -S-9 mix
Test 1 1, 2.5, 5, 10, 15, 30, 50 µg / ml
Test 2 1, 2.5, 5, 10, 15, 30, 50 µg / ml
Mutation tests: +S-9 mix
Test 1 0.1, 0.5, 1, 2.5, 5, 10, 15 µg / ml
Test 2 0.1, 0.5, 1, 2.5, 5, 10, 15 µg / ml - Vehicle / solvent:
- - solvent used: DMSO;
- Justification for choice of solvent: commonly used and accepted.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Used in the absence of S-9 mix
- Positive controls:
- yes
- Positive control substance:
- other: 20-methylcholanthrene
- Remarks:
- Used in presence of S-9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:as a solution
DURATION
- Preincubation period:
- Exposure duration: 3 hours @ 37°C
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 12 days
- Fixation time (start of exposure up to fixation or harvest of cells): 3 hours
SELECTION AGENT (mutation assays):4 pg trifluorothymidine TFT/mI
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 600 cells plated in cloning medium for estimation of viability (200 cells/90 mm petri dish) and a total of 3 x 1E+06 cells in selective medium for quantitation of mutation (1E+06 cells/90 mm petri dish)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth and cloning efficiency - Evaluation criteria:
- The criteria which must be satisfied before a positive response may be claimed are:
1. The induction of at least a two-fold increase in mutant frequency relative to the concurrent control by the test agent.
2. The demonstration of a statistically significant response.
3. Evidence of a dose-related response.
4. The response must be reproducible.
5. The data are acceptable according to the criteria detailed in Arlett et ai. (1989), in 'Statistical Evaluation of Mutagenicity Test Data', pp. 66 - 101, Cambridge University Press. - Statistics:
- The general method of statistical analysis was by analysis of variance of the mutant frequencies
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In the preliminary test on ODB-2 treatment with 0.5 - 50 µg/ml in the presence and absence of S-9 mix resulted in relative growth in suspension of 106 - 2% and 108 - 17% respectively. The concentrations used in the main test were based on this data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the absence of S-9 mix, treatment with 1 - 50 µg ODB-2/ml in tests 1 and 2 resulted in relative growth in suspension of 111 - 39% and 99 - 35% respectively. Cultures treated with 1, 15,30 and 50 µg/ml in test 1 and test 2 were assessed for viability. The resulting cell survival levels were 91 - 31% in test 1 and 93 - 26% in Test 2 relative to the controls.
In the presence of S-9 mix, treatment with 0.1 - 15µg ODB-2/ml in tests 1 and 2 resulted in relative growth in suspension of 110 - 31% and 112 - 5% respectively. Cultures treated with 0.5,5, 10 and 15 µg/ml in test 1 and 0.5, 1, 2.5 and 5 µg/ml in test 2 were assessed for viability. The resulting cell survival levels were 86 - 31% in test 1 and 95 - 23% in test 2 relative to the controls.
ADDITIONAL INFORMATION ON GENOTOXICITY:
In the absence of S-9 mix, cultures treated with 1, 15,30 and 50 µg/ml in test 1 and test 2 were assessed for induced mutation.Statistically
significant increases in mutant frequency were observed in both tests in the absence of S-9 mix. In test 2 the response was also dose-related. .Although this data does not fulfil all the criteria for a positive response (1. The induction of at least a two-fold increase in mutant frequency relative to the concurrent control by the test agent), the detection of a dose-related increase may be indicative of mutagenic potential.
In the presence of S-9 mix, cultures treated with 0.5,5, 10 and 15 µg/ml in test 1 and 0.5, 1, 2.5 and 5 µg/ml in test 2 were assessed for induced mutation.Statistically significant increases in mutant frequency were observed in test 1. However, these increases were small and considered to be non-biologically significant. - Remarks on result:
- other: strain/cell type: mouse lymphoma L5178Y cells
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
ambiguous without metabolic activation
The evidence for mutagenic potential of ODB-2 in the absence of S-9 mix is equivocal in this in vitro test system. There is no evidence for mutagenic potential in the presence of S-9 mix using this in vitro test system. - Executive summary:
S-205 and ODB-2 (Black 400), which is tested for its genotoxicity in a mouse lymphoma TK locus assay, are both colour precursor for heat sensitive record sheets. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that S-205 and ODB-2 have nearly the same chemical structure, the same mode of interaction with bio-macromolecules, living cells and tissue and metabolic pathway is expected. Therefore, a read-across from S-205 to data obtained with ODB-2 is scientifically justified.
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