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EC number: 422-930-1 | CAS number: 780759-89-9 JAUNE TZ 4210
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 July 1996 to 17 September 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- FAT 40549/A
- IUPAC Name:
- FAT 40549/A
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Batch No.: TV 1
- Colour: yellow -brown
- Stability: Pure: stable under storage conditions
In solvent: stable in aqua deionised for at least 48 hours
- Storage: room temperature
- Expiration Date : January 01, 2001
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40'549/A
Batch No: TV1
Expiration date: 01 Jan 2001
Stability in water: for atleast 48 hours
Solubility in water: approximately 90 mg/L at 20 degree celcius.
Aggregate state under storage conditions: solid (powder)
Colour: yellow brown.
Storage conditions: at room temperature
Safety precautions: Routine hygenic procudures are sufficient to assure personnel health and safety.
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, CH-4414 Füllinsdorf
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males mean value 33.2 g (SD ± 2.4 g); females mean value 26.7 g (SD ± 2.0 g)
- Assigned to test groups randomly: yes
- Housing: Makrolon Type I, with wire mesh top, granulated soft wood bedding
- Diet: pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±3 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): artificial light 6.00 a.m. - 6.00 p.m.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- aqua deionised
- Details on exposure:
- On the day of the experiment, the test article was formulated in aqua deioised. The vehicle was chosen to its non-toxicity for the animals. All animals received a single standard volume of 20 mL/kg body weight orally.
- Duration of treatment / exposure:
- 24 h and 48 h
- Frequency of treatment:
- a single administration
- Post exposure period:
- preliminary test: 48 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 670 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6 females and 6 males for each dose.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- CPA: Cyclophosphamide
Dissolved in: Aqua deionised
Dosing: 30 mg/kg b.w.
Route and Frequency of Administration: orally, once
Volume Administered: 10 ml/kg b.w.
Examinations
- Tissues and cell types examined:
- Two types of erythrocytes were observed in the bone marrow smears: normochromatic erythrocytes and polychromatic erythrocytes.
- Details of tissue and slide preparation:
- The animals were sacrificed by cervical dislocation. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a syringe. The cell suspension was centrifuged at 1500 rpm (390 x g) for 10 minutes and the supernatant was discarded. A small drop of the resuspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Griinwald (MERCK, D-64293 Darmstadt)/Giemsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KINDLER, D-79110 Freiburg). At least one slide was made from each bone marrow sample.
- Evaluation criteria:
- A test article is classified as mutagenic if it induces either a dose-related increase in the number of micronucleated polychromatic erythrocytes or a statistically significant positive response for at least one of the test points.
A test article producing neither a dose-related increase in the number of micronucleated polychromatic erythrocytes nor a statistically significant positive response at any of the test points is considered non-mutagenic in this system. - Statistics:
- Statistical significance at the five per cent level (p < 0.05) was evaluated by means of the non-parametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, test article is considered to be non-mutagenic in this in vivo micronucleus assay.
- Executive summary:
This study was performed according to OECD test guideline 474 to investigate the potential of FAT 40549/A to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse.
The test article was dissolved in aqua deionised. This vehicle was used as solvent control. The volume administered orally was 20 ml/kg b.w. 24 h and 48 h after a single administration of the test article the bone marrow cells were collected for micronuclei analysis.
Ten NMRI mouse (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. 1000 polychromatic erythrocytes (PCE) per animal were scored for micronuclei.
To describe a cytotoxic effect due to the treatment with the test article the ratio between polychromatic and normochromatic erythrocytes (NCE) was determined in the same sample and reported as the number of NCE per 1000 PCE.
The following dose levels of the test article were investigated:
24 h preparation interval: 200, 670 and 2000 mg/kg b.w.
48 h preparation interval: 2000 mg/kg b.w.
The highest guideline-recommended dose (2000 mg/kg) was estimated by a pre-experiment to be suitable. The animals expressed slight toxic reactions. After treatment with the test article the number of NCEs was not increased as compared to the corresponding solvent controls thus indicating that FAT 40 549/A had no cytotoxic effectiveness in the bone marrow.
In comparison to the corresponding solvent controls there was no significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test article and with any dose level used.
30 mg/kg b.w. cyclophosphamide administered per os was used as positive control which showed a distinct increase of induced micronucleus frequency.
Based on the findings of this study,the test article did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse. Therefore, FAT 40 549/A is considered to be non-mutagenic in this micronucleus assay.
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