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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Not a guideline study and publication does not report whether study performed according to GLP. Only a single dose used (ie effectively a limit dose study) However, data appears well documented and scientifically acceptable. 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:
- "Influence of chronic ethanol vapour inhalation on hepatic parenchymal and Kupffer cell function.
- Author:
- Di Luzio NR, Stege TE
- Year:
- 1 979
- Bibliographic source:
- Alcoholism: Clin Exp Res 3 (3) 240
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Animals exposed daily to a single concentration of ethanol vapour for a period of up to 26 days with the focus on liver toxicity. Interim sacrifice time points included to allow intermediate changes in blood ethanol levels and clinical chemistry to be followed.
- GLP compliance:
- not specified
- Limit test:
- yes
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:
- absolute ethanol
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Weight at study initiation: 200-300g
- Diet (ad libitum): Purina lab chow
- Water (ad libitum): tap
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass chamber (9x12x24 in.)
- Method of holding animals in test chamber: not applicable
- Source and rate of air: 9.3litres/min
- Method of conditioning air: filtered and dried
- System of generating vapour: air passed through a 19 litre chamber holding ethanol (1.5-2.5 litres) at 37C
- Temperature, humidity, pressure in air chamber:
- Air flow rate: 9.3 litres/min
TEST ATMOSPHERE
- Brief description of analytical method used: see details below
- Samples taken from breathing zone: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Assayed twice daily, in triplicate, sampled from chamber exit. Analysis using FID GC.
- Duration of treatment / exposure:
- 3, 6, 9, 26 day groups
- Frequency of treatment:
- continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20mg/l
Basis:
- No. of animals per sex per dose:
- 10
- Control animals:
- other: concurrent vehicle and pyrazole treated.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS/DETAILED CLINICAL OBSERVATIONS: Yes, no further data.
BODY WEIGHT: Yes
- Time schedule for examinations: every 2-3 days
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of exposure from vena cava
- Anaesthetic used for blood collection: Yes (phenobarbital)
- Animals fasted: No data
- How many animals: all
- Parameters checked: blood ethanol level
CLINICAL CHEMISTRY: Yes.
- Time schedule for collection of blood: end of exposure from vena cava
- Animals fasted: No data
- How many animals: all
- Parameters checked:- plasma retention of sodium sulfobromopthalein - Plasma activity of glutamic pyruvic transaminase and - glutamic oxalacetic transaminase - Liver triglycerides - Phagocytic function. Details of methods provided in reference.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- - Liver, lung and spleen histopathology.
- Statistics:
- Statistical analysis by Student's t-test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Initial exposure produced lethargy, ataxia and intoxication but animals adapted and appeared normal at the end of the study.
BODY WEIGHT AND WEIGHT GAIN
Ethanol exposure produced a small but not statistically significant retardation in bodyweight gain although not in the rate of gain.
HAEMATOLOGY
Blood ethanol levels in the ethanol-saline group peaked on day 9 at 126 +/- 40 mg/100ml and declined substantially 50-60% by day 26. In the ethanol-pyrazole group they peaked at 219 mg/100ml (+/- 35) on day 6 and then declined similarly to the ethanol-saline animals. No blood ethanol was measured in either the air-saline or air-pyrazole controls.
CLINICAL CHEMISTRY
Liver triglycerides were raised (doubled) for the ethanol groups at the earlier time points but were the same as the controls by day 26. Plasma tryiglycerides showed no consistent pattern. Plasma glutamic pyruvic transaminase levels were raised by 20% in the ethanol-saline group compared to the control.
HISTOPATHOLOGY: NON-NEOPLASTIC
Liver samples from the ethanol-saline group exhibited mild vacuolisaton for the early time periods, but this was not seen at 26 days. No other parameters were significantly effected between the ethanol-saline and air-saline groups.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 20 mg/L air
- Sex:
- male
- Basis for effect level:
- other: No biologically meaningful adverse changes noted.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
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:
- In a 26-day inhalation study rats were exposed to ethanol vapour at 20 000mg/m3. Only transient or biologically not meaningful adverse effects were observed, so no NOAEC was established.
- Executive summary:
In a study to examine the repeat dose toxicity of ethanol, rats were exposed to a single dose of ethanol vapour at 20mg/l for up to 26 days. Intermediate exposure groups were used to allow changes in clinical chemistry, histopathology and blood ethanol concentrations to be followed with time. The study found a number of transient effects (clinical signs, e.g lethary and ataxia, mild hepatic vacuolisation and changes to clinical chemistry parameters) but in animals exposed for the full 26 days, the only significant effect noted was an increase in plasma GPT levels, which, in isolation, was not regarded as biologically significant. It was noticeable that the blood ethanol levels in the animals exposed for 26 days were much lower than those exposed for shorter periods indicating pronounced induction of metabolic tolerance.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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