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EC number: 200-751-6 | CAS number: 71-36-3
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Fate of n-Butanol in Rats after Oral Administration and its uptake by dogs after inhalation or skin application
- Author:
- DiVincenzo GD, Hamilton ML
- Year:
- 1 979
- Bibliographic source:
- Toxicology and Applied Pharmacology 48: 317-325
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Objective of study:
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- n-[1-14C]Butanol was mixed with corn oil and administered by gavage to male Charles River CD (SD) rats in doses of 4.5, 45, or 450 mg/kg bw. The excretion of the n-[1-14C]Butanol was examined.
- GLP compliance:
- not specified
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:
- butan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Specific activity (if radiolabelling): 1.71 mCi/mmol
- Locations of the label (if radiolabelling): n-[1-14C]Butanol - Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 200-250 g
- Fasting period before study: 16 hours
- Housing: individually
- Individual metabolism cages: yes
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
[1-14C]-n-butanol was diluted with carrier and mixed with corn oil; a 1 mL mixture was administered by gavage at single doses of 4.5, 45 and 450 mg/kg bw. Each rat received between 0.224 and 28.4 µCi of radioactivity
VEHICLE
- Justification for use and choice of vehicle (if other than water): none given
- Concentration in vehicle: 1 mL mixture was administered by gavage at single doses of 4.5, 45 and 450 mg/kg bw
- Amount of vehicle: 1 mL - Duration and frequency of treatment / exposure:
- single oral application
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4.5 mg/kg bw (total dose)
- Dose / conc.:
- 45 mg/kg bw (total dose)
- Dose / conc.:
- 450 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- All animals were male.
It is not stated how many animals were used. It is stated that radioactivity recovery was calculated for 2 animals treated with 4.5 and 45 mg/kg bw and for 4 animals treated with 450 mg/kg bw. - Control animals:
- no
- Positive control reference chemical:
- no data
- Details on dosing and sampling:
- Animals were placed individually into metabolism chambers after treatment for sample collection.
PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, carcass, blood, CO2, organs: liver, kidney, lung, heart, brain, adrenal glands, fat
- Time and frequency of sampling: urine and faeces 24 hours after dosing; air traps at 4, 8, 12 and 24 after dosing; blood, fat and organs after 4, 8 and 24 hours
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine, breath and plasma
- Time and frequency of sampling: breath: air traps were changes at 4, 8, 12 and 24 after dosing; blood: 0.5, 1, 2, 4 and 8 h after dosing with 450 mg/kg bw; urine: 24 h after dosing
- From how many animals: breath and blood: individual; urine: pooled from 4 animals (pH adjusted to 7.0)
- Method type(s) for identification:GC-FID, TLC - Statistics:
- If 4 animals were evaluated the mean and standard deviation were calculated.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- distribution
- Results:
- highest concentrations: liver 3.88 % at 8 h, blood 0.74 % at 8 h, kidney 0.24 % at 4 h, other tissue < 0.12 %
- Type:
- excretion
- Results:
- Elimination of administered dose 450 mg/kg bw: > 44 % within 4 h, 69.3 % at 8 h, 83.3 % at 24 h
- Type:
- other: remaining radioactivity in carcass
- Results:
- at 4 h: 42.2 %; at 8 h: 27.2 %; at 24 h: 12.3 %
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Values are expressed as the percentage of the dose for four rats.
The highest concentrations of radioactivity were found in the liver (3.88 %) and blood (0.74 %) at 8 h and the kidney (0.24 %) at 4 h. The overall distribution of radioactivity in other tissues (0.12 % and less) was relatively low.
- Details on excretion:
- Radioactivity was eliminated rapidly in expired air as 14C02. In rats dosed with 450 mg/kg bw over 44 % of the administered dose was eliminated within 4 h; 69.3 and 83.3 % were eliminated at 8 and 24 h, respectively. Urinary radioactivity accounted for 4.4 % of the dose at 24 h. Fecal radioactivity was negligible at 4 and 8 h and was less than 1.0 % of the dose at 24 h.
The radioactivity remaining in the carcass was 42.2 % at 4 h, 27.2 % at 8 h, and 12.3 % at 24 h. The overall recovery of 14C was 86.7% at 4 hr, 99.6 % at 8 h, and 101 % at 24 h. Unchanged n-butanol in expired air accounted for less than 1.0 % of the dose. Rats dosed with 4.5 or 45 mg/kg bw showed a similar excretion pattern to that of rats dosed with 450 mg/kg bw.
The concentration of n-butanol in the plasma of rats dosed with 450 mg/kg bw was examined. The highest concentration of n-butanol was 70.9 µg/ml at 1 h. n-Butanol disappeared from the plasma rapidly and at 4 h was below the limit of detection.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Pooled 24 h urine collections from rats dosed with 450 mg/kg bw were treated with 3 N hydrochloric acid or beta-glucuronidase and then extracted with diethyl ether. The extract was counted and analyzed by gas chromatography. About 75 % of the radioactivity was detected as n-butanol, presumably both as an O-sulfate (44.4 %) and as an O-glucuronide (30.7 %). Urea accounted for the remainder of the radioactivity.
Less than 1 % of the administered dose was excreted unchanged.
Applicant's summary and conclusion
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