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EC number: 206-566-7 | CAS number: 354-64-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is performed in accrodance of OECD Guideline 474, and GLP and is well reportet
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Pentafluoroiodoethane
- EC Number:
- 206-566-7
- EC Name:
- Pentafluoroiodoethane
- Cas Number:
- 354-64-3
- Molecular formula:
- C2F5I
- IUPAC Name:
- 1,1,1,2,2-pentafluoro-2-iodoethane
- Details on test material:
- - Name of test material (as cited in study report): Pentafluorethyljodid
- Molecular weight (if other than submission substance): 246
- Physical state: gas
- Analytical purity: 98.9 %
- Vapour pressure: 1650 mbar at 20°C
- Boiling point: 11 °C
- Purity test date: n.a.
- Lot/batch No.: 26.08.2004
- Expiration date of the lot/batch: 2005-09-26
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rat: HanBrl:WIST (SPF)
- Age at study initiation: 11-12 weeks
- Weight at study initiation: (m) 197.6 - 232.0 g; (f) 200.0 - 229.1 g
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: in groups of three
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days
- Photoperiod (hrs dark / hrs light): 12 hour dark period/12 artificial fluorescent light
Administration / exposure
- Route of administration:
- inhalation: gas
- Vehicle:
- air
- Details on exposure:
- nose only exposure,
positive controls received respective item orally - Duration of treatment / exposure:
- 4 hour; nose only
- Frequency of treatment:
- one single exposure per dose group
- Post exposure period:
- 24 hours for
air control: Air
low dose: 12.500 ppm Pentafluoroethyljodid
medium dose: 25.000 ppm Pentafluoroethyljodid
high group; 50.000 ppm Pentafluoroethyljodid
positive control: 40 mg/kg bw CPA (oral)
48 hours for:
high dose group: 50.00 ppm Pentafluoroethyljodid
Doses / concentrations
- Remarks:
- Doses / Concentrations:
air, 12500, 25.000 and 50.000 ppm Pentafluoethyljodide, positive control CPA 40mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide (CPA)
- Justification for choice of positive control(s): not mentioned
- Route of administration: oral
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow, erythroblasts
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- The mean values of micronuclei observed after treatment with the test item were below or near to the value of the air control group.
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In conlusion, it can be stated that during the study described and under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the rat. Therefore, the test item is considered to be non-mutagenic in this micronucleus assay. - Executive summary:
The study was performed to investigate the potential of the test substance to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the rat. Ten animals (5/sex) per test group were evaluated for the occurrence of micronuclei. The test item doses administered by inhalation were 12500ppm, 25000 ppm and 50000 ppm. Air was used as control. The highest dose (50000 ppm) was estimated by pre-experiment to be suitable. 24 h and 48 h after the administration of the test item the bone marrow cells were collected for micronuclei analysis. At least 2000 polychromatic erythrocytes (PCEs) per animal were scored for micronuclei. To describe a cytotoxic effect due to the treatment with the test item the ratio between polychromatic and total erythrocytes was determined in the sample and recorded as the number of PCEs per 2000 erythrocytes. In the main study 1 male died after treatment with the high dose (50000 ppm). After treatment with the test item the number of PCEs was not substantially decreased as compared to the mean value of PCEs of the vehicle control air thus indicating that the test substance did not exert any cytotoxic effects to the bone marrow of the rat. In comparison to the corresponding vehicle controls there was no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test item and with any dose level used. 40 mg/kg bw cyclophosphamide administered orally was used as positive control which showed a substantial increase of induced micronucleus frequency.
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the rat. Therefore, the test item is considered to be non-mutagenic in this micronucleus assay.
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