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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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 March 2005 - 18 March 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only one mutagenicity experiment was performed
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, B.13., 8 June 2000
- Deviations:
- yes
- Remarks:
- only one mutagenicity experiment was performed
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation 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:
- Test item: BIOTOX-21
Appearance: brown liquid
purity: 100 %
Date of receipt: 21 February 2005
Storage conditions: at + 4 °C and protected from light
Constituent 1
Method
- Target gene:
- LT2
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Five dose levels of bio-oil
without S9 mix: 250, 500, 625, 750, 1000 and 1250 µg/plate, for all tester strains
with S9 mix: 250, 500, 625, 750, 1000 and 1250 µg/plate, for the TA 1535, TA 1537, TA 98 and TA 100 strains;625, 750, 1000, 1250, 2500 and 3750 µg/plate, for the TA 102 strain - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Anthramine
- Details on test system and experimental conditions:
- The bacterial strains were stored in cryoprotective medium in liquid nitrogen. The day before treatment, cultures were inoculated from frozen permanents: a scrape was taken under sterile conditions and put into approximately 6 mL of nutrient broth. The nutrient broth was placed under agitation in an incubator at 37 °C for about 14 hours, to produce bacterial suspensions.
The test item was tested in a preliminary test and one mutagenicity experiment. The preliminary test and the mutagenicity experiment were performed according to the direct plate incorporation method. - Evaluation criteria:
- a 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the (TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance were taken into account in the evaluation of the data obtained.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
PRELIMINARY TOXICITY TEST
The test item was freely soluble in the vehicle (DMSO) at 100 mg/mL. Consequently, with maximum treatment volume of 50 µL/plate, the dose levels were 10, 100, 500, 1000, 2500 and 5000 µg/plate. No precipitate was observed in the plates at any dose level. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and / or a thinning of the bacterial lawn.
Without S9 mix:
A moderate to marked toxicity was observed at dose levels ≥2500 µL/plate in the TA 98, TA 100 and TA 102 strains.
With S9 mix:
A moderate to marked toxicity was observed at dose levels ≥2500 µL/plate in the TA 98 and TA 100 strains and a marked toxicity was observed at 5000 µL/plate in the TA 102 strain.
MUTAGENICITY EXPERIMENT:
Without S9 mix:
The selected treatment levels were: 250, 500, 625, 750, 1000 and 1250 µg/plate, for all tester strains. No toxicity was observed at any dose level. Dose-related increases in the number of revertants were noted in the TA 98 and TA 102 strains.
With S9 mix:
The selected treatment levels were: 250, 500, 625, 750, 1000 and 1250 µg/plate, for the TA 1535, TA 1537, TA 98 and TA 100 strains;625, 750, 1000, 1250, 2500 and 3750 µg/plate, for the TA 102 strain.
A moderate toxicity was observed at 3750 µg/plate in the TA 102 strain. Dose-related increases in the number of revertants were noted in the TA 98, TA 100 and TA 102 strains.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
positive
Under experimental conditions, the test item showed mutagenic activity:
without S9 mix, in Salmonella typhimurium TA 98 and TA 102 strains
with S9 mix, in Salmonella typhimurium TA 98, TA 100 and TA 102 strains - Executive summary:
The potential of test item Fast Pyrolysis Bio-oil (BIOTOX-21) to induce reverse mutation in Salmonella typhimurium was evaluated in a guideline study Bacterial reverse mutation test. The test was performed in the absence and presence of a rat liver metabolizing system (S9 mix). The validity criteria of test were fulfilled. Under experimental conditions, the test substance showed mutagenic activity.
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