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EC number: 279-317-3 | CAS number: 79828-43-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EEC Directive 92/69, L383, Annex V, B12, dated December 29, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- FAT 40210/E
- IUPAC Name:
- FAT 40210/E
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- purity approx. 90%, red-violet solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals: Strain-NMRI; Source: BRL, CH-4414 Füllinsdorf;
Number of Animals: 36 males/36 females;
Initial Age at start of Acclimatization: 8-12 weeks;
Acclimatization: minimum 5 days;
Initial body weight at start of treatment: males mean value 31.0g (SD±2.5g), female mean value 23.4 g (SD±1.5g).
The animals were in healthy condition and under quarantine in the animal house of CCR for a minimum of five days after their arrival. During this period the animals did not show any signs of illness or altered behavior. The animals were distributed into the test groups at random and identified by cage number.
Environmental conditions
Husbandry: the animals were kept conventionally. The experiment was conducted under standard laboratory conditions;
Housing: single; Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen);
Bedding: granulated soft wood bedding (ALTRONIM, D-32791 Lage/Lippe);
Feed: pelleted standard diet, ad libitum ((ALTRONIM 1324, D-32791 Lage/Lippe);
Water: tap water, ad libitum, (Gemeindewerke, D-64380 Robdarf); E
nvironment: temperature 21±3 ℃, relative humidity 30-70 %, artificial light 6.00 a.m.-6.00 p.m.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- deionised water
- Details on exposure:
- test material: a single standard volume of 20ml/kg bogy weight orally (200, 670 and 2000 mg/kg b.w. respectively);
Vehicle control: orally, once, 20 ml/kg b.w.;
Positive control: orally, once, 40 mg/kg b.w.(20 mg/kg b.w.) - Duration of treatment / exposure:
- 24 h and 48 h
- Frequency of treatment:
- once
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:
- 5 per sex per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
Examinations
- Tissues and cell types examined:
- 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-Grunwald (MERCK, D-64293 Darmstadt)/Giemsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KINDLER, D-79110 Freibur). At lease 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. This can be confirmed by means of the nonparametric Mann-Whitney test. However, both biological and statistical significance should be considered together.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse
- Toxicity:
- no effects
- Remarks:
- None of the animals expressed toxic reactions treated with 2000 mg/kg b.w. and FAT 40210/E had no cytotoxic properties in the bone marrow.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- FAT 40210/E was considered to be non-mutagenic in the micronucleus assay.
- Executive summary:
The study was performed to investigate the potential of FAT 40210/E to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse.
The following dose levels of the test article were investigated: 24 h preparation interval: 200, 670 and 2000 mg/kg b.w.(20ml/kg b.w.), 48 h preparation interval: 2000 mg/kg b.w.(20 ml/kg b.w.).
FAT40210/E had no cytotoxic effectiveness in the bone marrow and did not induced micronuclei by the micronucleus test with bone marrow cells of the mouse. FAT40210 was considered to be non-mutagenic in the micronucleus assay according to CLP Regulation (Regulation EC No. 1272/2008).
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