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EC number: 202-440-0 | CAS number: 95-68-1
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-02-11 to 1991-09-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP study according to former version of OECD technical guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted May 26, 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- EEC Directive 84/449
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2,4-xylidine
- EC Number:
- 202-440-0
- EC Name:
- 2,4-xylidine
- Cas Number:
- 95-68-1
- Molecular formula:
- C8H11N
- IUPAC Name:
- 2,4-dimethylaniline
Constituent 1
Method
- Target gene:
- Chromosome aberration
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: CHO cell line, supplied by Toxicology Department Bayer AG, Dr. Lehn, D-5600 Wuppertal, Germany
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Study I/II (with and without S9 mix)
8h: 300; 500; 700; 900; 1000 µg/mL
24h: 30; 100; 300, 500; 700; 900; 1000 µg/mL
30h: 300; 500; 700; 900; 1000 µg/mL
- Vehicle / solvent:
- - DMSO (Merck, D-6100 Darmstadt, Germany)
- Purity >= 99.5%
- Final concentration in culture medium did not exceed 1% v/v
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Dissolved in nutrient medium, final concentration: 0.72mg/mL
Migrated to IUCLID6: Without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Dissolved in nutrient medium, final concentration 4.20µg/mL
Migrated to IUCLID6: With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4hrs
- Expression time (cells in growth medium): 8, 24, 30h
SPINDLE INHIBITOR (cytogenetic assays): 5, 21 and 27h after start of the treatment colcemid was added to the cultures
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 200 per test group (100 per slide)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- Mutagenicity:
- A dose-related increase in number of structural chromosomal aberrations OR
- A reproducible significant positive response for at least one of these test points
Both, biological and statistical significance should be considered together - Statistics:
- Statistical significance at the five per cent level (p < 0.05) was evaluated by means of chi-square test
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 100 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 100 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Toxic effects were observed in both cytogenetic experiments evidenced by reductions of the mitotic indices after treatment at least in the samples scored treated with the top concentrations
- In both experiments, there were clonal effects in the CHS cell line revealing dicentric marker chromosomes distributed randomly in the treatment and control groups; therefore, dicentric chromosomes were recorded but not included in the calculation of the aberration rates
- Due to their random distribution this measure did not affect the validity of the study - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
In conclusion, it can be stated that in the described study and under the experimental conditions reported, the test article 2,4-Xyldine induced structural chromosome aberration in the CHO cell line in the presence of metabolic activation and was non-mutagenic in the absence of S9 mix. - Executive summary:
Based on the results of this chromosome aberration study 2,4-Xylidine was non-mutagnic in the absence and mutagenic in the presence of metabolic activtion.
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