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EC number: 931-740-0 | CAS number: -
- 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:
- 2010 May 19 to 2010 June 23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline 471 study performed and reported following GLP standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Distillation residue, butyl alcohols production, rectification
- EC Number:
- 931-740-0
- Molecular formula:
- undefined (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Distillation residue, butyl alcohols production, rectification
- Details on test material:
- Solvent-still residue of butyl alcohol rectification, Composite sample K-303-III. A composite sample, consisting of 5 sub-samples taken over a period of 3 consecutive days, was collected directly from the process line. The volume of each sub-sample was approximately 5-10 L. The sub-samples were combined, resulting in a total volume of ca. 50 L. This ca. 50 L composite sample was split into two equal portions of ca. 25 L each (control sample and laboratory sample). The ca. 25 L laboratory sample was further split into two portions of ca. 5 L and 20 L before sending for analysis at two separate laboratories. After sampling and sample splitting, all the portions of the composite sample were stored at +4 deg Celsius.
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Range-finding assay: Test article was freshly prepared in DMS0 and seven concentrations from range 0.0001 - 5.0 mg/plate were tested without and with metabolic activation.
According to the results of range-finding assays (with and without metabolic activation) six tested doses were selected for testing. Concentrations of test product ranged between 0.0001 and 0.1 mg/plate. - Vehicle / solvent:
- dimethylsulphoxide (DMSO) (purum) Lot 1104114 (Fluka)
Controls
- Untreated negative controls:
- yes
- Remarks:
- dimethylsulphoxide (DMSO)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide (DMSO)
- True negative controls:
- yes
- Remarks:
- dimethylsulphoxide (DMSO)
- Positive controls:
- yes
- Remarks:
- without activation: sodium azide: TA 1535, 2-nitrofluorene:TA 98, 9-aminoacridine: TA 97, mitomycin C: TA 102. With activation: 2-acetamidofluorene: TA 98.
- Details on test system and experimental conditions:
- As described in OECD guideline 471.
- Evaluation criteria:
- Positive results: concentration-related increase over the tested range and reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation. MF>2. Student's test was used for evaluation of statistical significance of mutation frequency increasing against solvent control value.
- Statistics:
- Data were presented as the number of revenant colonies per plate. The mean numbers of revertant colonies per plate and the standard deviations were presented for the test substance and positive and negative controls.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In experiments without metabolic activation the concentration of 5 mg/plate were toxic against all strains Salmonella typhimurium. In experiments with metabolic activation, the concentrations of 5 and 1 mg/ml decreased the number of revertants.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
The Solvent still residue of butyl alcohol rectification in accordance with these results is considered non mutagenic in this system.
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