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EC number: 479-950-7 | CAS number: 31274-51-8
- 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 cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-05-22 - 2008-06-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 486) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Version / remarks:
- adopted on 21st July 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Test material form:
- other: Solid (bulk) and solid-liquid suspension (dispersion containing micronized ETH50 (nano form))
- Details on test material:
- Please refer to "Confidential details on test material".
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France origin, Saint-Germain-sur-l'Arbresle, France
- Age at study initiation: 5 to 6 weeks old
- Weight at study initiation: 180 g to 215 g (12-16-hour expression time), 164 g to 207 g (2-4-hour expression time)
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: polypropylene cages measuring 42.5 x 26.6 x 15 cm, covered by a stainless steel netted lid, in which male rats were placed in groups of 3 or 2; bedding consisted of dust-free, sterilized wood shavings
- Diet: A04C10 irradiated rat/mouse feed from SAFE
- Water: Drinking water softened, treated by osmosis and filtered on 0.2 µm membrane, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: 20 changes/hour
- Photoperiod: 12 hours dark/ 12 hours light
IN-LIFE DATES: From: 2007-01-15 To: 2007-08-29 (in-life and slide reading phase)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicles/solvents used:
Distilled water (FAT 65’080/E and FAT 65’080/E Placebo)
Carboxymethylcellulose at 0.5% in distilled water (FAT 65’080/B)
- Justification for choice of solvent/vehicle: solubility of the test item
- Amount of vehicle: 10 mL/kg bw - Duration of treatment / exposure:
- Single administration
- Frequency of treatment:
- Single administration
- Post exposure period:
- - Test item group animals dosed were sacrificed 2 or 12 hours after treatment for cell collection (2-4 hour or 12-16 hour expression time)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
nominal conc.
FAT 65’080/B
- Remarks:
- Doses / Concentrations:
1000, 2000 mg/kg bw
Basis:
nominal conc.
FAT 65’080/E
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
nominal conc.
FAT 65’080/E Placebo
- No. of animals per sex per dose:
- 3 male rats
- Control animals:
- other: distilled water
- Positive control(s):
- - Dimethylhydrazine (10 mg/kg bw) for the 2-4-hour expression time
- 2-acetamidofluorene (25 mg/kg bw) for the 12-16-hour expression time
- Route of administration: oral route
Examinations
- Tissues and cell types examined:
- Liver - prepared hepatocyte cultures
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
- From the results of a preliminary toxicity test.
TREATMENT AND SAMPLING TIMES:
- Normal expression time: 12-16 hours after dosing (first assay)
- Earlier expression time: 2-4 hours after dosing (second assay)
Preparation of hepatocyte cultures:
Three animals were assigned randomly for hepatocytes sampling in each group. Individual animals were anaesthetized and prepared for perfusion of the liver with Hepes buffer kept at 37°C at 40 mL/min for 5 minutes. The liver was then perfused using a collagenase buffer at 37°C at 20 mL/min for 5 minutes. At the end, the liver became 'spongy'. It was cut free into nylon 150-µm filter-funnel positionned on a sterile tube. The Glisson's capsule was carefully cut open and the hepatocytes were released by adding complete Williams's culture medium (WE-C). The hepatocyte suspension was centrifuged and the resulting pellet was resuspended in WE-C. The centrifugation and resuspension procedure was repeated twice and the hepatocyte pellets were resuspended in WE-C. The proportion of viable cells was determined with the help of a Malassez haemocytometer using trypan blue technique. A volume of 3 mL was transferred to each well of 6-well multiplates containing round plastic coverslips coated with collagen. Twelve replicate wells per animal were prepared. The cultures were incubated at 37°C in an atmosphere of 5 % CO2 for approximately 90 minutes to allow attachment to the coverslips.
Radiolabelling of hepatocyte cultures:
After this attachment period, the supernatant medium was removed and the cells gently washed with Williams E medium-Incomplete (WE-I) and then replaced with WE-I containing 10 µCi/mL of 3H Thymidine. Cultures were incubated for 3 - 8 hours at 37 °C in an atmosphere of 5 % CO2. At the end of the labelling period, the supernatant medium was removed and the cells were washed three times with WE-I medium containing 0.25 mM unlabelled thymidine to diminish unincorporated radioactivity ("cold-chase"). Then, the cultures were incubated overnight with 3 mL of the same solution.
DETAILS OF SLIDE PREPARATION:
The cells were rinsed with WE-I medium, fixed 3 times using a Carnoy mix (ethanol-acetic acid), and washed with distilled water at least 4 times. After that, the coverslips were dried at room temperature and finally, mounted on slides with EUKITT.
Autoradiography: Six of the 12 slides from each animal were coated in Kodak NTB-2 liquid emulsion. After gelling, the slides were incubated in a light-tight box and left refrigerated for 10-14 days. At the end of of this time, the emulsion was developed and fixed. The cell nuclei and cytoplasm were stained with Meyers hemalum. Slides were dehydrated in ethanol, cleared in xylene and mounted with coverslips for microscopic examination.
METHOD OF ANALYSIS:
Grain counting was performed using an image analysis system (Visilog, Noesis, France). Where possible, nuclear and cytoplasmic grain counts were obtained from 50 cells per slide, 3 slides per animal (test article treatments, solvent and positive controls). Each slide was examinated to ensure that the culture was viable. Each slide was scanned and cells scored such that there was no risk that the same cell was counted more than once. Nuclear (NC) and cytoplasmic (CC) grain counts were recorded, and the net nuclear grains (NNG) per cell was determined (NNG = NC-CC). - Evaluation criteria:
- The following criteria were used for analysis of slides:
1. Only cells with normal morphology were scored.
2. Isolated nuclei with no surrounding cytoplasm were not scored.
3. Cells with unusual staining artefacts were not scored.
4. Heavily labelled cells in S-phase were not scored.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- no unscheduled DNA synthesis in rat hepatocytes
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF THE RANGE-FINDING STUDY
- In the preliminary toxicity assay, 2 groups of 4 male Fischer rats were dosed once at 2000 mg/kg bw of the test item.
- Following dosing, the animals were observed regularly for a period of at least 48 hours and any clinical signs and any mortalities were recorded.
- No clinical signs and no incidences of mortality were noted in rats treated with the test item
- Under these conditions, the UDS test was performed with 2000 mg/kg bw of the test item
RESULTS OF THE DEFINITIVE STUDY
- In the UDS assay performed with 12 - 16 or 2 - 4-hour expression times, no significant increase in the mean net nuclear grain count values of cells in repair (NNG > 5) were noted when compared to control and the mean percentages of cells in repair were comparable with the solvent controls. Furthermore, frequencies of cells in S-phase were low.
- Thus, all items tested did not reveal any genotoxic activity under the test conditions.
- Regarding the animals treated with FAT 65`080/E and /B (at 2000 mg/kg bw), systemic exposure with the respective test substance was demonstrated.
Applicant's summary and conclusion
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