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EC number: 281-865-3 | CAS number: 84045-63-6
- 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: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 402-740-3
- EC Name:
- -
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: FAT 40'277/B
Lot/batch No.: Vers. 1367/87 VO
Stability: Pure: stable for 60 months, In solvent: > 8 hours in H2O, DMSO, and DMF
Storage: room temperature
Expiration date of the lot/batch: August 1992
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zentralinstitut für Versuchstierzucht D-3000 Hannover, F.R.G.
- Age at start of Acclimatization: minimum 10 weeks
- Weight at start of treatment: approximately 30 g
- Fasting period before study: approximately 18 hours
- Housing: Individually in Makrolon type-1 cages with wire mesh top (EBECO, D-4620 Castrop-Rauxel, F.R.G.) with granulated soft wood bedding (ALTROMIN, D-4937 Lage/Lippe, F.R.G.)
- Diet: pelleted standard diet (ALTROMIN, D-4937 Lage/Lippe, F.R.G.)
- Water: tap water, ad libitum (Südhessische Gas- und Wasser AG, D-6100 Darmstadt)
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): relative humidity not regulated
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: aqua dest
- Justification for choice of solvent/vehicle: The vehicle was chosen to its non-toxicity for the animals.
- Concentration of test material in vehicle: 3000 mg/kg bw
- Amount of vehicle: 20 mL/kg bw - Frequency of treatment:
- Single treatment
- Post exposure period:
- 24, 48, and 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide;
- Route of administration: oral (gavage)
- Doses: 30 mg/kg bw
- Volume administrated: 10 mL/kg bw
Examinations
- Tissues and cell types examined:
- Normochromatic and polychromatic erythrocytes
- Details of tissue and slide preparation:
- DETAILS OF 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 2.0 mL fetal calf serum, using a 5 mL syringe, into 1 mL fetal calf serum. The cell suspension was centrifuged at 1,000 rpm for 5 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-Gruenwald/Giemsa. Cover slips were mounted with EUKITT (KINDLER, D-7800 Freiburg F.R.G.). At least one slide was made from each bone marrow sample.
METHOD OF ANALYSIS:
Evaluation of the slides was performed using NIKON microscopes with 100x oil immersion objectives. 1000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in same sample and expressed in normochromatic erythrocytes per 1000 PCEs. The analysis was performed with coded slides. Five animals per sex and group were evaluated as described. The remaining animal of each test group was evaluated in case an animal had died in its test group spontaneously or due to gavage error. - Evaluation criteria:
- The frequencies of micronucleated PCEs in the groups treated with the test article are compared with their corresponding negative controls. Positive responses are those in which an increase of micronucleated PCEs can be confirmed statistically significant at the five per cent level (p < 0.05). However, both biological and statistical significance should be considered together in the evaluation.
- 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
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- in vivo
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- In a pre-experiment 2 animals (1 male, 1 female) received orally a single dose of 1000, 1500, 2000, or 3000 mg/kg bw. FAT 40'277/B dissolved in aqua dest. The volume administered was 20 mL/kg bw. Animals in the 1000 and 1500 mg/kg bw dose group did not express toxic reactions. The males in the 2000 mg/kg bw group expressed toxic reactions including reduction of spontaneous activity and apathy. The females however expressed no toxic reactions. Animals of the 3000 mg/kg bw dose group showed reduction of spontaneous activity, eyelid closure and apathy. The mean number of normochromatic erythrocytes was not increased after treatment with the test article as compared to the mean values of NCEs of the corresponding negative controls indicating that FAT 40'277/B had no cytotoxic properties.
RESULTS OF DEFINITIVE STUDY
- In comparison with the corresponding negative controls there was no substantial enhancement in the frequency of the detected micronuclei at any preparation interval after application of the test article. Biometric analysis proved no significant difference between control and test article groups.
- 30 mg/kg b.w. cyclophosphamide administered per os was used as positive control which showed a distinct increase of induced micronuleus frequency.
Applicant's summary and conclusion
- Conclusions:
- The test substance did not induce micronuclei in bone marrow cells of the mouse.
- Executive summary:
In a GLP-compliant erythrocyte micronucleus test, tested according to OECD guideline 474, 6 NMRI mice per sex were treated once by oral gavage with the test substance (3000 mg/kg bw) dissolved in water followed by a 24, 48 and 72 hours post exposure period. In pre-experiments 3000 mg/kg bw was estimated to be the maximum tolerated dose. Based on the finding that the mean number of normochromatic erythrocytes was not increased after treatment with the test article as compared to the negative controls, that the test substance had no cytotoxic properties. In comparison with the corresponding negative controls there was no enhancement in the frequency of the detected micronuclei at any preparation interval after application of the test article and therefore it could be concluded that the test substance did not induce micronuclei in this study.
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