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EC number: 208-719-3 | CAS number: 539-48-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- publication
- Title:
- Chromosomal Aberration Test in CHL/IU Cell
- Year:
- 2 000
- Bibliographic source:
- JAPAN CHEMICAL INDUSTRY ECOLOGY- TOXICOLOGY AND INFORMATION CENTER, JAPAN; MUTAGENICITY TEST DATA OF EXISTING CHEMICAL SUBSTANCES BASED ON THE TOXICITY INVESTIGATION OF THE INDUSTRIAL SAFETY AND HEALTH LAW; (SUPPL. 2), 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Standard for Chromosomal Aberration Test in Cultured Mammalian Cells" of the Notification No.652 of the Labour Standards Bureau, Ministry of Labour, Japan
- Version / remarks:
- September 29, 1997
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- p-phenylenebis(methylamine)
- EC Number:
- 208-719-3
- EC Name:
- p-phenylenebis(methylamine)
- Cas Number:
- 539-48-0
- Molecular formula:
- C8H12N2
- IUPAC Name:
- 1,4-Bis(aminomethyl)benzene
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Lot No.: FBX01
Purity: 99.5%
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung cells
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: supplied by Dr. M. Ishidate, Jr. in 1985
- Modal number of chromosomes: 25
- Doubling time: approximately 15 hours
MEDIA USED
- Type and identity of media including CO2 concentration if applicable: Eagle's MEM supplemented with 10% heat-inactivated (56°C, 30 min) calf serum
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 24 and 48 h treatment: 0.015, 0.03, 0.06, 0.09, 0.12, 0.15 mg/mL
6h treatment: 0.05, 0.1, 0.2, 0.3, 0.4 mg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test substance was soluble in DMSO and insoluble in water.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with and without S9
- Details on test system and experimental conditions:
- - Short-period treatment with and without Metabolic Activation (6 hours treatment):
Twenty thousands cells were seeded in culture vessel (with 5 mL of culture medium) and cultured for three days, then culture medium was changed. Cells were simultaneously treated with and without S9 mix and the test substance solution for 6 hours. Then, the test substance mixture was changed to fresh culture medium. After 18 hours further culture, rates of cell growth inhibition were determined.
- Continuous Treatment without Metabolic Activation (24 and 48 hours treatment):
Twenty thousands cells were seeded in a culture vessel (with 5 mL of culture medium), and cultured for three days. Then culture medium was changed and the test substance solution was added to a culture medium. After 24 or 48 hours treatment, rates of cell growth inhibition were determined.
- Determination of Cell Growth Inhibition Rate
The medium was discarded and the cells were washed with physiological saline. Ethanol was added to fix the cells which were then stained with 0.1% crystal violet. After washing and drying, each dish was placed under a cell densitometer to measure the color absorption value (550nm). The cell growth index was calculated with the negative control being 100% and Petri dish without cells being 0%.
- Slide preparation:
Two hours before the end of culture, the cells were treated with 0.2μg/mL Colcemid. After finishing culture, they were dissociated with trypsin (0.1% trypsin + 0.036% EDTA) and centrifuged (1000 rpm, 5 min) to collect cells. After removal of the supernatant, the cells were incubated in a 75 mM hypotonic KCl solution for 20 minutes at 37 °C. The cells were then fixed three times with acetic acid-ethanol (1:3) and spread onto clean glass slides. Each slide was stained with Giemsa solution (2.5% at pH 6.8) for 12 minutes after air-drying.
- Observation:
The number of cells with structural aberrations in 100 well-spread metaphase cells were counted per each culture vessel. The incidence of polyploid cells were recorded simultaneously. - Evaluation criteria:
- Negative: frequencies of structural aberrations and of polyploidy less than 5%
Equivocal: frequencies of structural aberrations and of polyploidy from 5% to less than 10%
Positive: frequencies of structural aberrations and of polyploidy 10% or more
Results and discussion
Test results
- Key result
- Species / strain:
- other: Chinese hamster lung cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Negative result got for test item in chromosomal aberration test in CHL.
- Executive summary:
In vitro mammalian chromosome aberration test for test item was performed using lung cells of a newborn Chinese hamster according to "Standard for Chromosomal Aberration Test in Cultured Mammalian Cells" of the Notification No.652 of the Labour Standards Bureau, Ministry of Labour, Japan. The dose level were 0.015, 0.03, 0.06, 0.09, 0.12, 0.15 mg/mL for 24 and 48 h treatment without S9 mix activation, 0.05, 0.1, 0.2, 0.3, 0.4 mg/mL for 6h treatment with and without S9 mix activation. The recovery time forshort-period treatment (6h) was 18 h.
Negative result was given under the test condition.
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