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Diss Factsheets
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EC number: 221-410-8 | CAS number: 3087-36-3
- 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
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:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is reasonably well reported but there are deviations from an guideline protocol. It can be considered sufficiently well reported to be an acceptable study with sufficient basic documentation to demonstrate that it meets basic scientific principles and contains enough detail to be able to judge the results 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:
- Acute motor and lethal effects of inhaled toluene, 1,1,1-trichloroethane, halothane and ethanol in mice: effects of exposure duration.
- Author:
- Moser, V. and Balster
- Year:
- 1 985
- Bibliographic source:
- Toxicol Appl. Pharmacol 77:285-291.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- , Exposure period only 60 minutes. Species mouse rather than preferred rat. Observations reported for only 3 days rather than 14. Volume of chamber 29 litres (above 20 litres) . No detailed observations of effects. No pathology.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- - Analytical purity: 95% USP
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, WIlmington, MA
- Age at study initiation: Not stated
- Weight at study initiation: 25 - 30 g
- Housing: standard mouse cages with wood chip bedding in groups of 6
- Diet at libitum (Rodent lab chow 5001, Ralston Purina Mills, St Louis, MO)
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 24°C
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass chambers
- Exposure chamber volume: 29 litre
- Method of holding animals in test chamber: not restrained
- System of generating vapour: Solvent placed on a filter paper in the chamber which was suspended beneath a fan.
TEST ATMOSPHERE
- Brief description of analytical method used: verified using a single wavelength infrared spectrometer through a closed loop re-circulating pump
- Samples taken from breathing zone: no. Samples taken from different parts of the chamber prior to the study to ensure homogenous atmosphere so sampling could be done with confidence from the top of the chamber during the study. - Duration of exposure:
- 60 min
- Concentrations:
- 40,000, 50,000 and 60,000 ppm for different exposure duration.
- One exposure period per exposure level.
- Exposure duration: 60, 30, and 10 minutes. - No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 72 days.
- Necropsy and target organs: not applicable. - Statistics:
- Analysis by the probit analysis of Bliss (Quart J Pharmac, 11, 192, 1938) after log transformation and LC50 plus confidence limits calculated.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 60 000 ppm
- Exp. duration:
- 60 min
- Sex:
- male
- Dose descriptor:
- other: EC50
- Effect level:
- 49 570 ppm
- 95% CL:
- > 47 000 - < 52 600
- Exp. duration:
- 10 min
- Remarks on result:
- other: based on motor performance test.
- Sex:
- male
- Dose descriptor:
- other: EC50
- Effect level:
- 32 500 ppm
- 95% CL:
- > 27 800 - < 37 750
- Exp. duration:
- 30 min
- Remarks on result:
- other: based on motor performance test.
- Sex:
- male
- Dose descriptor:
- other: EC50
- Effect level:
- 30 300
- 95% CL:
- > 28 000 - < 32 750
- Exp. duration:
- 60 min
- Remarks on result:
- other: based on motor performance test.
- Mortality:
- No LC50 was determined as no deaths occurred at any of the exposure concentrations.
- Clinical signs:
- other: Slight to moderate ataxia was observed and recovery from this exceeded 4 hours at all exposure levels.
- Body weight:
- no data
- Gross pathology:
- not performed
Any other information on results incl. tables
Recovery from the exposure as assessed using the motor performance test was slow. There was incomplete recovery up to 4 hours after exposure for all exposure period cohorts.
All of the reported EC50 values are above the lower explosive limit reported in chapter 4. Based on the vapour pressure in chapter 5, the saturated vapour concentration would be 55,000ppm, therefore the maximum exposure in this study must be saturated vapour.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute toxicity inhalation study, mice were exposed to ethanol for different periods of time up to 1 hour. An LC50 could not be obtained; no deaths were reported for exposures up to 60,000ppm (114mg/l).
- Executive summary:
In an acute toxicity inhalation study, mice were exposed to ethanol for different periods of time up to 1 hour in order to determine the LC50 and the EC50 for motor performance. An LC50 could not be obtained for inhalation exposure; no deaths were reported for exposures up to 60,000ppm (114mg/l), which can be considered the saturated vapour concentration. In the motor performance test, an EC50 60 min value of 30,300ppm was established, with a slope for the dose effect curve of 12.6. This result differered only slightly from the EC50 30 min. Whilst exposures were only for 1 hour, the evidence suggests that exposures for 4 hours would not have significantly reduced the motor performance results or the LC50. It should be noted that all of the reported EC50 values are above the lower explosive limit reported in chapter 4. On this basis and based on the result in mice, inhalation exposure poses little hazard at any feasible exposure concentration.
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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