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EC number: 227-006-8 | CAS number: 5593-70-4
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of 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: The study investigated the toxicokinetics of n-butanol measured according to standard protocol but guideline followed was not mention.
Cross-reference
Reference
- Endpoint:
- basic toxicokinetics
- Type of 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: The study investigated the toxicokinetics of n-butanol measured according to standard protocol but guideline followed was not mention.
- Objective of study:
- absorption
- distribution
- excretion
- toxicokinetics
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Radiolabelling:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles RIver Laboratories
- Weight at study initiation: 200-250 g
- Fasting period before study: 16 hours
- Housing: Glass Delmar Roth metabolism chambers
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 deggres
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours night - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Radiolablelled n-(1-14C) Butanol was mixed with corn oil
- Duration and frequency of treatment / exposure:
- single dose administration
- Remarks:
- Doses / Concentrations:
4.5, 45, 450 mg/kg of body weight - Control animals:
- yes
- Positive control reference chemical:
- none
- Details on study design:
- - Dose selection rationale: Not reported
- Rationale for animal assignment (if not random): not reported - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine, serum or other tissues, cage washes, expired CO2
- Time and frequency of sampling: 4, 8, 24 hpurs
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled : urine, faeces, tissues, cage washes, bile
- Time and frequency of sampling: 4, 8, 24 hours
- Method type(s) for identification (e.g. GC-FID, GC-MS, Liquid scintillation counting, NMR, TLC) - Details on absorption:
- Concentration of n-butanol in the plasma of rats dosed with 450 mg/kg. Each point is the mean + SE for three rats. The highest concentration of n-butanol was 70.9 pg/ml at I hr. n-Butanol disappeared from the plasma rapidly and at 4 hr was below the limit of detection.
- Details on distribution in tissues:
- The tissue distribution of radioactivity in rats dosed with 450 mg/kg n-[1J4C]butanol is presented in Table 2. 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 hr. The overall distribution of radioactivity in other tissues was relatively low. Pooled 24-hr urine collections from rats Dosed with 450 mg/kg were treated with 3 N hydrochloric acid or fi-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 o/0). Urea accounted for the remainder of the radioactivity.
- Details on excretion:
- Percentage of the total radioactivity recovered in the breath, urine, feces, and carcasses of rats dosed with it- [ 1 J4C]butanol. Radioactivity was eliminated rapidly in expired air as 14C0,. In rats dosed with 450 mg/kg over 44% of the administered dose was eliminated within 4 hr; 69.3 and 83.3 % were eliminated at 8 and 24 hr, respectively. Urinary radioactivity accounted for 4.4% of the dose at 24 hr. Fecal radioactivity was negligible at 4 and 8 hr and was less than 1.0% of the dose at 24 hr. The radioactivity remaining in the carcass was 42.2 % at 4 hr, 27.2 % at 8 hr, and 12.3 % at 24 hr. The overall recovery of 14C was 86.7 “/:, at 4 hr, 99.6% at 8 hr, and 101 % at24 hr. Unchanged n-butanol in expired air accounted for less than 1.0 % of the dose. Rats dosed with 4.5 or 45 mg/kg showed a
similar excretion pattern to that of rats dosed with 450 mg/kg. - Metabolites identified:
- yes
- Details on metabolites:
- Butanol was excreted in the urine apparently as an o-sulfate and as an o-glucuronid both of which accounted for 75% of the radioactivity.
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
According to this study oral administration of radiolabelled butanol dosed at 4.5, 45, 450 mg/kg. Less than 1% of the administered dose was excreated unchanged and 2.6 to 5.2 % of the dose was excreated in urine.
Read-across justifications and data matrices are presented in IUCLID section 13.
Data source
Reference
- 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, G.D. and Hamilton, M.L.
- Year:
- 1 979
- Bibliographic source:
- Toxicology and Applied Pharmacology 48, 317-325
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
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): n-butanol
- Physical state: liquid
- Radiochemical purity (if radiolabelling): >97%
- Specific activity (if radiolabelling): 1.71 mCi/mmol
- Stability under test conditions: stable
- Storage condition of test material: stable
- Locations of the label (if radiolabelling): n-(1-14C) Butanol
Constituent 1
Constituent 2
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles RIver Laboratories
- Weight at study initiation: 200-250 g
- Fasting period before study: 16 hours
- Housing: Glass Delmar Roth metabolism chambers
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 deggres
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours night
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Radiolablelled n-(1-14C) Butanol was mixed with corn oil
- Duration and frequency of treatment / exposure:
- single dose administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4.5, 45, 450 mg/kg of body weight
- Control animals:
- yes
- Positive control reference chemical:
- none
- Details on study design:
- - Dose selection rationale: Not reported
- Rationale for animal assignment (if not random): not reported - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine, serum or other tissues, cage washes, expired CO2
- Time and frequency of sampling: 4, 8, 24 hpurs
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled : urine, faeces, tissues, cage washes, bile
- Time and frequency of sampling: 4, 8, 24 hours
- Method type(s) for identification (e.g. GC-FID, GC-MS, Liquid scintillation counting, NMR, TLC)
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Concentration of n-butanol in the plasma of rats dosed with 450 mg/kg. Each point is the mean + SE for three rats. The highest concentration of n-butanol was 70.9 pg/ml at I hr. n-Butanol disappeared from the plasma rapidly and at 4 hr was below the limit of detection.
- Details on distribution in tissues:
- The tissue distribution of radioactivity in rats dosed with 450 mg/kg n-[1J4C]butanol is presented in Table 2. 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 hr. The overall distribution of radioactivity in other tissues was relatively low. Pooled 24-hr urine collections from rats Dosed with 450 mg/kg were treated with 3 N hydrochloric acid or fi-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 o/0). Urea accounted for the remainder of the radioactivity.
- Details on excretion:
- Percentage of the total radioactivity recovered in the breath, urine, feces, and carcasses of rats dosed with it- [ 1 J4C]butanol. Radioactivity was eliminated rapidly in expired air as 14C0,. In rats dosed with 450 mg/kg over 44% of the administered dose was eliminated within 4 hr; 69.3 and 83.3 % were eliminated at 8 and 24 hr, respectively. Urinary radioactivity accounted for 4.4% of the dose at 24 hr. Fecal radioactivity was negligible at 4 and 8 hr and was less than 1.0% of the dose at 24 hr. The radioactivity remaining in the carcass was 42.2 % at 4 hr, 27.2 % at 8 hr, and 12.3 % at 24 hr. The overall recovery of 14C was 86.7 “/:, at 4 hr, 99.6% at 8 hr, and 101 % at24 hr. Unchanged n-butanol in expired air accounted for less than 1.0 % of the dose. Rats dosed with 4.5 or 45 mg/kg showed a
similar excretion pattern to that of rats dosed with 450 mg/kg.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Butanol was excreted in the urine apparently as an o-sulfate and as an o-glucuronid both of which accounted for 75% of the radioactivity.
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): no bioaccumulation potential based on study results
According to this study oral administration of radiolabelled butanol dosed at 4.5, 45, 450 mg/kg. Less than 1% of the administered dose was excreated unchanged and 2.6 to 5.2 % of the dose was excreated in urine.
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