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EC number: 212-850-1 | CAS number: 873-74-5
- 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
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-19 (date test substance received) to 2004-09-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- Only 100 cells were scored per concentration. In addition, the study did not provide information on mitogen stimulation or a spindle inhibitor (or addition time).
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 4-aminobenzonitrile
- EC Number:
- 212-850-1
- EC Name:
- 4-aminobenzonitrile
- Cas Number:
- 873-74-5
- Molecular formula:
- C7H6N2
- IUPAC Name:
- 4-aminobenzonitrile
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- Sponsor's identification : 4-Aminobenzonitrile
Description : Yellow crystalline solid
Chemical name : 4-cyanoaniline, p-cyanoaniline, 4-cyanobenzene amine
Purity : 100%
Label : 4-Aminobenzonitrile 98% lot: A017112501
Date received : 19 May 2003
Storage conditions : Room temperature in the dark
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 2 % rat liver homogenate metabolising system
- Test concentrations with justification for top dose:
- The dose range for the toxicity test was 4.62 to 1181.4 µg/ml, based on a 10mM maximum dose level.
- Preliminary toxicity test: 0, 4.62, 9.23, 18.46, 36.92, 73.84, 147.68, 295.35, 590.7 and 1181.4 μg/mL
The selection of the dose range for the chromosome aberration test was based on the maximum recommended dose level, 1181.4 µg/ml for the pulse exposure groups and for the 24 hours exposure group:
- Group 1 (4(20)-hour without S9): 0, 36.92, 73.84, 147.68, 295.35, 590.7, 1181.4 μg/mL (0, 295.35, 590.7 and 1181.4 μg/mL were selected for metaphase analysis.)
- Group 2 (4(20)-hour with S9): 0, 36.92, 73.84, 147.68, 295.35, 590.7, 1181.4 μg/mL (0, 295.35, 590.7 and 1181.4 μg/mL were selected for metaphase analysis.)
- Group 3 (24-hour without S9): 0, 36.92, 73.84, 147.68, 295.35, 590.7, 1181.4 μg/mL (0, 295.35, 590.7 and 1181.4 μg/mL were selected for metaphase analysis.) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Yes, identity not provided.
- Justification for choice of solvent/vehicle: no data
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- identity of vehicle control was not provided.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation; at 10 μg/ml for the 4(20) hour exposure (group 2)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- identity of vehicle control was not provided.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation; at 0.4 μg/ml for the 4(20) hour exposure and 0.2 μg/mL for the 24 hour continuous exposure (Groups 1 and 3 respectively)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
no data
DURATION
- Exposure duration: 4 hours (Groups 1 and 2); 24 hours (Group 3)
- Expression time: 20 hours (Groups 1 and 2) was provided in the study report as the expression period. However, no information was given on the time of addition of a spindle inhibitor ; 0 hours (Group 3)
- Fixation time: 24 hours (all groups)
SPINDLE INHIBITOR (cytogenetic assays): no data
STAIN (for cytogenetic assays): no data
NUMBER OF REPLICATIONS:
2 cultures were treated per group. Except where there was the need to clarify an equivocal response, only one of the duplicate cultures was assessed for the incidence of cells with chromsome aberrations.
NUMBER OF CELLS EVALUATED: 100 cells per evaluated culture. Slide evaluation was terminated at 50 cells when approximately 50% cells with aberrations are observed (positive controls)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: investigated
- Rationale for test conditions:
- Dose selection for metaphase analysis was therefore based on the maximum 10mM dose level, 1181.4 µg/ml all the exposure groups.
- Evaluation criteria:
- A positive response was recorded for a treatment if the % cells with aberrations, excluding gaps, markedly exceeded that seen in the concurrent control, either with or without a clear dose-relationship. For modest increases in aberration frequency a dose response relationship is generally required and appropriate statistical tests may be applied in order to record a positive response.
- Statistics:
- No data provided on the tests performed.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: there was no precipitate of test material observed at any dose level in any exposure group in the preliminary toxicity test.
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES:
A preliminary toxicity test was conducted at a dose range of 4.62 to 1181.4 µg/mL, based on a 10 mM maximum dose level. There was no precipitate of test substance observed at any dose level in any exposure group. Microscopic assessment of the slides prepared from the treatment cultures showed that metaphase cells were present at up to 1181.4 µg/mL in all the exposure groups. The mitotic index data showed that there was no evidence of toxicity following exposure to the test substance. Therefore, the selection time of the dose range for the chromosome aberration test was based on the maximum recommended dose level, 1181.4 µg/mL for all groups in the main study.
COMPARISON WITH HISTORICAL CONTROL DATA:
Vehicle control and positive control data were compared with historical control data. All of the vehicle and positive control cultures had frequencies of cells with chromosome aberrations within the expected range. The positive control materials induced statistically significant increases in the frequency of cells with aberrations. It was therefore considered that the metabolic activation system was shown to be functional and the test method itself was operating as expected.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A microscopic assessment of the slides showed that metaphase cells were present at up to 1181.4 ug/mL in all groups. The test substance did not induce mitotic inhibition at any dose level in any group.
OTHER:
The test substance did not induce a statistically significant increase in the numbers of polyploid cells in any of the exposure groups. - Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
The test substance did not induce statistically significant increases in the frequency of cells with chromosome aberrations in the absence or presence of a liver enzyme metablizing system after 4(20) hours exposure or after a 24-hour continuous exposure. The test substance was therefore considered to be non-clastogenic to human lymphocytes in vitro.
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