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Diss Factsheets
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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study intended to determine co-exposure effect of xylene and n-butyl alcohol, rotarod performance and respiratory depression measured according to standard protocol but guideline followed was not mention. 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:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rotarod performance was tested according to the principle described by Kaplan and Murphy.
- GLP compliance:
- not specified
- Test type:
- other:
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
- Test material form:
- other: vapours, generated by heating liquid solvent
- Details on test material:
- - Name of test material: :n-butyl alcohol
- Substance type solvent
- Physical state: vapours, generated by heating liquid
Constituent 1
Constituent 2
Test animals
- Species:
- other: Rats and mice
- Strain:
- other: Wistar rats and balb/c mice
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DAK Stock outbred
- Weight at study initiation: 250-300g for rats and 25-30 g mice
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- other:
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dynamic inhalation chamber
- Exposure chamber volume: 1.3 M^3
TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of solvent vapours were measured every 30 min with a gas chromatograph with flame ionization detector using 1.5 m metal column with 10% OV -17 on chromosorb WHP (80-100 mesh) as a stationary phase at column temprature of 100 C. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gas chromatography
- Duration of exposure:
- 4 h
- Remarks on duration:
- 4hr exposure period was for rats and mice exposed for 6 min as to determine respiratory depression.
- Concentrations:
- Exposure concentration of n-butyl alcohol were expressed in ppm and 1 ppm of n-butyl alcohal = 3.08 mg/m3. and for n- butyl alcohol exposed concentration range was 100 to 100000 ppm.
- No. of animals per sex per dose:
- 8-10 male mice per group for measuring respiratory rate
10 male rats per group for measuring rotarod performance - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: no data
- Other examinations performed: Rotarod performance was tested before exposure and immediately after exposure to several concentration of n-butyl alcohol and in control animal for 1 hour.
The respiratory pattern was recorded continuously before the exposure solvents, during 6 min of exposure and 6 min after termination of exposure.
Spontaneous motor activity was measured by the use of UMA-2-10 actometer during one hour immediately after termination of 4 hour exposure to rats - Statistics:
- Probit analysis was applied to determin the medial effective concentration (EC50 and RD50 value). Frequency data were also compared using the Chi-square test.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- other: EC 50
- Effect level:
- 6 531 ppm
- Based on:
- other: rotarod performance
- 95% CL:
- 4 950 - 10 370
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- other: RD50: concentration dependent decrease in respiratory rate to 50%
- Effect level:
- 3 008 ppm
- Based on:
- other: plethysmographic method
- Mortality:
- no data
- Clinical signs:
- other: 1) Depression of central nervous system 2) irritation of eyes and upper respiratory tract
- Body weight:
- no data
- Gross pathology:
- no data
- Other findings:
- - Potential target organs: Central nervous system
Any other information on results incl. tables
All rats exposued for 4 hours to the tested concentrations of n-butyl alcohol and mixture survived the exposure, both solvents and thair mixture caused concentration dependent disturbances in rotarod performance of rats (refer the attached background material).
Both m-xylene and n-butyl alcohol caused a concentration dependent decrease in respiratory rate in mice (refer the attached background materia).
N-butyl alcohol and mixture solvents changed the spontaneous motor activity in the rat (refer the attached background materia).
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In this study neurotoxicity of n-butanol assessed on the basis of rotarod performance and spontaneous motor activity and the irritation effect was quantified by measurement of respiratory rate in mice. For n-butanol EC50 ( medial effective concentration) and RD50 (concentration dependent decrease in respiratory rate to 50%) were determined as 6531 ppm and 3008 ppm respectively.
- Executive summary:
As the target substance hydrolyses immediately (half-life <2 hours) the intrinsic properties are related to this main organic degradation product (butanol) of the target substance. This information is used as a weight of evidence in CSA.
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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