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EC number: 201-696-0 | CAS number: 86-74-8
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Clastogenicity of carbazole in mouse bone marrow cells in vivo
- Author:
- Jha AM, Sing AC, and Bharti MK
- Year:
- 2 002
- Bibliographic source:
- Mutat Res 521, 11-17
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- : only male animals, reporting of results not meeting requirements
- Principles of method if other than guideline:
- No guideline stated, but the method used is equivalent to OECD test guideline 475. The test performed is based the method described in Preston et al (1987), Mutat Res 189, 157-165, and Tice et al (1994), Mutat Res 312, 303-312.
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Carbazole
- EC Number:
- 201-696-0
- EC Name:
- Carbazole
- Cas Number:
- 86-74-8
- Molecular formula:
- C12H9N
- IUPAC Name:
- 9H-carbazole
- Details on test material:
- - Name of test material (as cited in study report): carbazole (purchased from Sigma, USA)
- no further information on test substance
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility
- Amount of vehicle: 0.2 mL of 10% DMSO in phosphate buffered saline
- Test substance was predissolved in DMSO and then diluted with phosphate buffered saline to the concentration required for administration. - Details on exposure:
- Doses of test substance were administered dissolved in 0.2 mL of 10% DMSO in phosphate buffered saline by intraperitoneal injection.
- Duration of treatment / exposure:
- single treatment
- Post exposure period:
- Bone marrow was collected 14 and 42 hrs after treatment of test animals.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 50, 100, 150, and 200 mg/kg bw
Basis:
other: nominal injected
- No. of animals per sex per dose:
- 12 (2 groups of 6 male animals each)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - mitomycin C
- Justification for choice of positive control(s): no data
- Route of administration: i.p. injection
- Doses / concentrations: 1.5 mg/kg bw in 0.2 mL phosphate buffered saline
Examinations
- Tissues and cell types examined:
- Bone marrow from both femora
- Statistics:
- students t-test, two-way ANOVA
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- after 14-h exposure at 150 and 200 mg/kgbw
- Toxicity:
- yes
- Remarks:
- at the highest dose, based on pre-tests clinical symptoms
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: single i.p. doses of 200, 300, and 400 mg/kg bw tested in groups of 15 male mice each; observation period 15 days
- Clinical signs of toxicity in test animals: at 400 mg/kg bw, 10 mice died within 2 days. At 300 mg/kg bw, 9 mice out of 15 died after 6 days. At 200 mg/kg, all animals survived. Toxic symptoms such as ataxia and lack of appetite disappeared within 2 hours after treatment. Based on the still apparent toxicity of carbazole at 200 mg/kg bw, this dose was selected as the upper dose limit for the definite study.
- Evidence of cytotoxicity in tissue analyzed: not examined
Any other information on results incl. tables
A general, dose-dependent trend of mitotic depression after carbazole treatment was evident for both, the 14 hr and 42 hr sampling period. But a statistically significant reduction of the mitotic index compared to solvent control was only observed for the 150 and 200 mg/kg bw group after 14 h exposure. In general, mitotic indices at 14 hr sampling time were lower than for the 42 h sampling period.
A slight dose-dependent, but not statistically significant increase in chromosome aberration was also observed, ranging from near background values for the 25 mg/kg group to statistically significant increases at 150 mg/kg (sampling time 14 h) and at 200 mg/kg (sampling time 14 and 42 h). Exposure for 14 h resulted in stronger clastogenic effect than the exposure for 42 h. Compared to the positive control (Mitomycin C) and taking into account the different doses, the effect observed for carbazole was at least 200 times lower. More detailed results are presented in the file "Tables results…" attached under "Attached background material".
In conclusion, the results of this study demonstrate that carbazole is moderately clastogenic in the bone marrow cells of mouse in vivo under the test conditions used.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
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