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EC number: 500-687-1 | CAS number: 162303-51-7
- 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 cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Though no guideline was followed the experiments performed and results presented can be considered reliable. Read-across justification: The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the toxicokinetics of target substance. Because of the rapid hydrolysis, the influence of the mode of administration through inhalation, dermal and oral is related to the hazardous degradation product (alcohol) released from the target substance. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance, which might change the hazardous properties of the target substance compared to the properties of the pure alcohol. As there is a mechanistic reasoning to the read-across, the unnecessary animal testing is avoided by using the read-across data from the degradation product (relevant alcohol) to evaluate irritation, sensitization and the short term and long-term toxicological effects and mutagenicity of the target substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- The in vitro micronucleus assay for detection of cytogenetic effects induced by mutagen-carcinogens: comparison with the in vitro sister-chromatid exchange assay
- Author:
- Lasne C., Gu Z., venegas W., Chouroulinkov I.
- Year:
- 1 984
- Bibliographic source:
- Mutation Reasearch, Vol 130, PN. 273-282
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The induction potential of micronuclei was analyzed after exposure of the chinese hamster lung (V79) cells to n-butanol.
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- 1-Butanol
- Details on test material:
- - Name of test material (as cited in study report): 1- butanol
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagles MEM supplemented with 10% foetal salf serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes/
- Periodically checked for karyotype stability: yes/
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 50 µl/dish
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Medium, Acetone
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- methylmethanesulfonate
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation; in suspension
DURATION
- Preincubation period:15-18 hrs
- Exposure duration: 1hr
-
SPINDLE INHIBITOR (cytogenetic assays): colchicine in sister chromatide exchange
STAIN (for cytogenetic assays):Fluroscent dye Hoechest 33258 (5 ug/ml)
NUMBER OF CELLS EVALUATED: 4000-7000 interphase cellswith visible cytoplasm were scored per treatment - Evaluation criteria:
- The criteria used to score micronucleus included
(1)staining intensity equal to that of nucleus
(2) diameter less then one fifth that of the nucleus
(3) location in cytoplasm
(4) no contact with nucleus. - Statistics:
- The dose response of V79 cells to chemical mutagen has been estimated by linear regression curves.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Read-across justifications and data matrices are presented in IUCLID section 13.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
This study evaluated genotoxicity potential of n-butanol using in vitro micronucleus assay. n-Butanol at concentration up to 50 µl/dish failed to induce micronuclei. Based on this result n-butanol can be concluded as non genotoxic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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