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EC number: 692-061-0 | CAS number: 1207435-39-9
- 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:
- supporting study
- Study period:
- 01.01.2003-30.06.2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Guideline study, final study report not available. Results published in BIOTOX project (BIOTOX. 2005. An assessment of bio-oil toxicity for safe handling and transportation. Final Technical Report. Part I: Publishable Final Report. Report drafted by Blin, J. Project N°: S07.16365. Project co-ordinator: Centre de Coopération Internationale de Recherche Agronomique pour le Développement (Cirad). Partners: Aston University, Bundesforschungsanstalt für Forst- und Holzwirtschaft (BFH)).
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive No. 2000/32/EC, B12, 8 June 2000
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Fast Pyrolysis Bio-oil (BIOTOX-21)
- IUPAC Name:
- Fast Pyrolysis Bio-oil (BIOTOX-21)
- Test material form:
- liquid: viscous
- Details on test material:
- BIOTOX 21: Biomass: Spruce, produced with Fluidised bed at 500 °C
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Swiss, Ico: OF1 (IOPS Caw).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Upon their arrival at CIT, the animals were housed in an animal room, with the following environmental conditions: temperature: 22 ± 2°C . relative humidity: 30 to 70% . light/dark cycle: 12 h/12 h (07:00 - 19:00) . ventilation: at least 12 cycles/hour of filtered non-recycled fresh air. The temperature and relative humidity are under continuous control and recording. The housing conditions (temperature, relative humidity and ventilation) and corresponding instrumentation and equipment are verified and calibrated at regular intervals. The animals were housed by groups in polycarbonate cages. Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Corn oil
- Details on exposure:
- For the vehicle and the test item:
. Route: oral, since it is a possible route of exposure in Man,
. Frequency: two treatments separated by 24 hours
. Volume: ≤ 20 mL/kg.
For the positive control (CPA):
. Route: oral
. Frequency: one treatment,
. Volume: 10 mL/kg, - Duration of treatment / exposure:
- 48 h
- Frequency of treatment:
- Twice, separated by 24 h
- Post exposure period:
- 24 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 500, 1000 and 2000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide 50 mg/kg
Examinations
- Tissues and cell types examined:
- Blood, bone marrow
- Details of tissue and slide preparation:
- The femurs were removed and the bone marrow was flushed out with fetal calf serum. After centrifugation, the supernatant were removed and the cells in the sediment were resuspended by shaking. A drop of this cell suspension was placed and spread on a slide. The slides were coded so that the scorer is unaware of the treatment group of the slide under evaluation (“blind” scoring).
- Evaluation criteria:
- For each animal, the number of micronucleated polychromatic erythrocytes (MPE) were counted, the polychromatic (PE) and normochromatic (NE) erythrocyte ratio was established by scoring a total of 1000 erythrocytes (PE + NE). The analysis of the slides was performed at CIT or at Microptic, cytogenetic services (2 Langland Close Mumbles, Swansea SA3 4LY, UK).
For a result to be considered positive, there must be: a statistically significant increase in the frequency of MPE when compared to the vehicle control group. Reference to historical data, or other considerations of biological relevance may be taken into account in the evaluation of data obtained. - Statistics:
- MPE in each treated group were compared with those in the concurrent vehicle control groups by using a 2 x 2 contingency table to determine the χ2 value (Lovell et al, 1989) (d). If there was significant within-group heterogeneity, then that group was compared with the control group using a non-parametric analysis, the Mann-Whitney test (Schwartz, 1969) (e). The student "t" test was used for the PE/NE ratio comparison. Probability values of p ≤ 0.05 was considered as significant.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- No bone marrow toxicity (the ratio of polychromatic and normochromatic erythrocytes did not change.
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: only vehicle controls
- Positive controls validity:
- valid
- Additional information on results:
- No significant increase in the frequency of micronucleated cells was observed in animals treated with the bio-oil sample. Analyses on blood samples would be necessary to confirm inactivity of the bio-oil sample.
Any other information on results incl. tables
No significant increase in the frequency of micronucleated cells was observed in animals treated with the bio-oil sample. Analyses on blood samples could not be carried out due to highly complex nature of the test item and the lack of suitable kinetic indicators. However, highest dose was as high as 2000 mg/kg/day (given twice), and in the acute toxicity study and 7-day repeated toxicity study clear systemic effects were observed (NOAEL 150 mg/kg/day). Therefore, it is likely that after the high exposure levels of the present study the components of test item are present in circulation and therefore also in the bone marrow.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
No significant increase in the frequency of micronucleated cells was observed in animals treated with the bio-oil sample. - Executive summary:
In the MAS test the potential of bio-oil to induce damage to the chromosomes or mitotic apparatus in bone marrow cells of mice (after 2 oral administrations) was assessed in vivo. No significant increase in the frequency of micronucleated cells was observed in animals treated with the bio-oil sample at the dose levels up to 2000 mg/kg/day.
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