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EC number: 205-447-7 | CAS number: 141-01-5
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Primary mutagenicity screening of the given test chemical
- Author:
- Ishidate et al.
- Year:
- 1 984
- Bibliographic source:
- Food Chem Toxicol
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- in vitro mammalian chromosome aberration study was conducted for the given test chemical.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Fumaric acid
- EC Number:
- 203-743-0
- EC Name:
- Fumaric acid
- Cas Number:
- 110-17-8
- Molecular formula:
- C4H4O4
- IUPAC Name:
- (2E)-but-2-enedioic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Name of the test chemical: Fumaric acid
IUPAC name: (2E)-but-2-enedioic acid
Molecular Formula: C4H4O4
Molecular Weight: 116.072 g/mol
Substance Type: Organic
Physical State: Solid
Constituent 1
Method
- Target gene:
- No data
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung-derived fibroblasts (CHL)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells: The cell line was originally established from the lung of a newborn female at the Cancer Research Institute, Tokyo (Koyama, Utakoji & Ono, 1970),
For cell lines:
- Absence of Mycoplasma contamination: No data
- Number of passages if applicable: 4-day passages
- Methods for maintenance in cell culture: The cell line was maintained in Minimum Essential Medium (MEM; GIBCO) supplemented by 10% calf serum.
- Cell cycle length, doubling time or proliferation index : The doubling time was approximately 15 hr.
- Modal number of chromosomes: The modal chromosome number is 25 - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Colcemid (final conc 0.2 microgm/ml) was added to the culture 2 hr before cell harvesting.
- Metabolic activation:
- without
- Metabolic activation system:
- no metabolic activation systems were applied
- Test concentrations with justification for top dose:
- 0, 0.5 µg/ml. Top dose was expected to produce a 50% inhibition of cell growth based on data from a pre-experiment.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used [none; no data; acetone; arachis oil; beeswax; carbowaxe; castor oil; cetosteryl alcohol; cetyl alcohol; CMC (carboxymethyl cellulose); coconut oil; corn oil; cotton seed oil; DMSO; ethanol; glycerol ester; glycolester; hydrogenated vegetable oil; lecithin; macrogel ester; maize oil; olive oil; paraffin oil; peanut oil; petrolatum; physiol. saline; poloxamer; polyethylene glycol; propylene glycol; silicone oil; sorbitan derivative; soya oil; theobroma oil; vegetable oil; aqueous solvents (water or saline or culture medium)] : Physiological saline
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- DURATION
- Exposure duration: 24 & 48 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
NUMBER OF CELLS EVALUATED: 100
DETERMINATION OF CYTOTOXICITY
- Method: 50% cell growth inhibition
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- Results were considered negative if incidence of aberrations was less than 4.9%, equivocal if it was between 5 and 9.9% and positive if it was more than 10%
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- other: Chinese hamster lung-derived fibroblasts (CHL)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
Chromosome aberration test (CA) in mammalian cells:
o Changes in ploidy (polyploidy cells and cells with endoreduplicated chromosomes) if seen: 0% polypliody was observed.- Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Results of the chromosomal aberration study:
Polypliody(%) | Structural aberrations (%) | hours |
0 | 1 | 24 |
Applicant's summary and conclusion
- Conclusions:
- The test chemical tested negative for mutachromosomal effects in Chinese hamster lung-derived fibroblasts (CHL).
- Executive summary:
In vitro mammalian chromosome aberration study was conducted for the given test chemical in Chinese hamster lung-derived fibroblasts (CHL) in the absence of metabolic activation system. The cell line was originally established from the lung of a newborn female at the Cancer Research Institute, Tokyo (Koyama, Utakoji & Ono, 1970), and was maintained by 4-day passages in Minimum Essential Medium (MEM; GIBCO) supplemented by 10% calf serum. The modal chromosome number is 25 and the doubling time was approximately 15 hr. The cells were exposed to chemical at three concentrations up to 0.5 µg/ml for 24 and 48 hr. Physiological saline was used as solvent. The top dose was expected to produce a 50% inhibition on cell growth based on data from a pre-experiment. Colcemid (final conc 0.2 µg/ml) was added to the culture 2 hr before cell harvesting. The cells were then trypsinized and suspended in a hypotonic KCI solution (0.075 M) for 13 min at room temperature. After centrifugation the cells were fixed with acetic acid-methanol (1:3, v/v) and spread on clean glass slides. After air-drying, the slides were stained with Giemsa solution (1.5%, at pH 6.8; E. Merck) for 12-15 min. A hundred well-spread metaphases were observed under the microscope (x 600 with a no cover objective lens). The incidence of polyploid cells as well as of cells with structural chromosomal aberrations such as chromatid or chromosome gaps, breaks, exchanges, ring formations, fragmentations and others, was recorded on each culture plate. Results were considered negative if incidence of aberrations was less than 4.9%, equivocal if it was between 5 and 9.9% and positive if it was more than 10%. The test chemical tested negative for mutachromosomal effects in Chinese hamster lung-derived fibroblasts (CHL).
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