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EC number: 406-860-7 | CAS number: -
- 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:
- 13 August 1990 to 19 November 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Revised Chemical Substance Law (1987) according to the notification of December 9, 1986 by EA, Environmental Agency (No. 700); MHW, Ministry of Health and Welfare (No. 1039) and MITI, Ministry of International Trade and Industry (No. 1014), Japan.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: FAT 40'400/A
Lot/batch No.: BG 3247/TV 6
Stability: Pure: stable for 5 years, In solvent: > 72 hours in water, methanol, acetone, DMSO, and DMF
Storage condition of test material: room temperature
Expiration date of the lot/batch: March 1995
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under storage conditions: Pure: 5 years; In solvent: in water, methanol, acetone, DMSO and DMF > 72 hours
- Stability under test conditions:
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- aroclor 1254 induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Evaluated test concentrations: with and without S9 mix: 7 hours: 5.0 mg/mL, 18 hours: 0.5, 4.0, 5.0 mg/mL, 28 hours: 5.0 mg/mL
- Vehicle / solvent:
- culture medium without fetal calf serum
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation: Two days old logarithmically growing stock cultures more than 50 % confluent were trypsinised and a single cell suspension was prepared. The cells were seeded into Quadriperm dishes ( Heraeus, D-6450 Hanau, F.R.G. ) which contained microscopic slides (2 chambers per dish and test group). In each chamber 5E4 - 1E5 cells were seeded with regard to preparation time. The medium was MEM + 10 % FCS.
- Exposure: After 48 hours (7 hours, 28 hours preparation interval) and 55 hours (18 hours preparation interval) the medium was replaced with serum-free medium containing the test article, either without S9 mix or with 20 µL/mL S9 mix. After 4 hours this medium was replaced with normal medium after rinsing twice with 'saline G'.
- Fixation: 5, 15.5 and 25.5 hours after the start of the treatment colcemid was added (0.2 µg/mL culture medium) to the cultures. 2 hours (7 hours
interval) or 2.5 hours later, (18 hours and 28 hours interval) the cells were treated on the slides in the chambers with hypotonic solution (0.4 % KCl) for 20 minutes at 37 °C. After incubation in the hypotonic solution the cells were fixed with 3 + 1 absolute methanol + glacial acetic acid. All two slides per group were prepared. After fixation the cells were stained with Giemsa (Merck, D-6100 Darmstadt, F.R.G.).
NUMBER OF CELLS EVALUATED:
- At least 100 well spread metaphases per slide were scored for cytogenetic damage on coded slides. Only metaphases with characteristic chromosome number of 22 ± 1 were included in the analysis.
DETERMINATION OF CYTOTOXICITY
- To describe a cytotoxic effect the mitotic index (% cells in mitosis) was determined. - Evaluation criteria:
- A test article is classified as mutagenic if it induces either a significant dose-related increase in the number of structural chromosomal aberrations or a significant positive response for at least one of the test points. A test article producing neither a significant dose-related increase in the number of structural chromosomal aberrations nor a significant and reproducible positive response at any one of the test points is considered non-mutagenic in this system.
- Statistics:
- chi-square test
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- - Additional information on genotoxicity:
Both, in the absence and presence of S9 mix the test article did not increase significantly the frequency of cells with aberrations at any fixation interval. The aberration rates of the cells after treatment with the test article (0.5 % - 4.0 %) were in or near to the range of the control values : 0.0 % - 2.0 %. At fixation interval 18 hours in the absence of S9 mix in one sample treated with 4.0 mg/mL the aberration rate (4.0 %) was slightly increased as compared to the control value (2.0 %). This effect was observed only in one of the duplicate cultures. As this value falls within our historical data range: 0.0 % - 4.0 % the observed effect is not regarded as biologically relevant. Also, the occurrence of two exchanges is restricted to this sample and do not influence in this case the evaluation of the test article. Therefore, a dose-depended increase in the exchange rate (1 % with 4.0 mg; 1.5 % with 5.0 mg/mL) can not be evaluated unequivocally. In addition, the exchange rate found in the sample treated with 5.0 mg/mL is near to our historical exchange control range. 0.0 % - 1.0 %.
- Additional information on cytotoxicity:
In the pre-experiment on toxicity (colony forming ability) in the presence of S9 mix after treatment with 5.0 mg/mL the colony forming ability was distinctly reduced; in the absence of S9 mix only a slight reduction was observed. Higher concentrations were not applied. Also, in the main experiment the mitotic index was reduced in the high dose range (1.0 - 5.0 mg/mL) at fixation intervals 7 and 28 hours both in the presence and absence of S9 mix. At fixation interval 18 hours, only in the presence of S9 mix some indications of toxicity were observed (using the mitotic index as indicator). - Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- FAT 40400/A is considered to be not clastogenic in this chromosomal aberration test.
- Executive summary:
In a GLP-compliant chromosome aberration test, tested according to OECD guideline 473, chinese hamster lung fibroblast (V79) were exposed to the test substance with and without metabolic activation.
The test article FAT 40400/A was assessed for its potential to induce structural chromosome aberrations in V79 cells of the Chinese hamster in vitro. Preparation of chromosomes was done 7 h (high dose), 18 h (low, medium and high dose), and 28 h (high dose) after start of treatment with the test article. The treatment interval was 4 h. In each experimental group two parallel cultures were used. Per culture 100 metaphases were scored for structural chromosomal aberrations.
The following dose levels were evaluated:
without S9 mix:
7 h: 5.0 mg/ml
18 h: 0.5; 4.0; 5.0 mg/ml
28 h: 5.0 mg/ml
with S9 mix:
7 h: 5.0 mg/ml
18 h: 0.5; 4.0; 5.0 mg/ml
28 h : 5.0 mg/ml
The concentration range of the test article applied had been determined in a pre-experiment using the plating efficiency assay as indicator for toxicity response. Treatment with 5.0 mg/ml reduced distinctly the plating efficiency of the V79 cells in the presence of S9 mix; in the absence of S9 mix only a slight reduction was observed. Also, toxic effects were observed in the main experiment using the mitotic index as indicator for toxicity. Higher concentrations than 5.0 mg/ml were not applied. There was no relevant increase in cells with structural aberrations after treatment with the test article at any fixation interval either without or with metabolic activation by S9 mix. Appropriate reference mutagens were used as positive controls and showed distinct increases in cells with structural chromosome aberrations. In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article did not induce structural chromosome aberrations as determined by the chromosomal aberration test in the V79 Chinese hamster cell line. Therefore, FAT 40400/A is considered to be non-clastigenic in this chromosomal aberration test.
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