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Diss Factsheets
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EC number: 200-578-6 | CAS number: 64-17-5
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Critical study for SIDS endpoint Acceptable, study with sufficient basic documentation to demonstrate that study meets basic scientific principles and contains enough detail to be able to judge the results reliable as a contribution to the understanding of the acute toxicity of this substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative lethality of methanol, ethanol and mixtures in female rats.
- Author:
- Youssef, A., Madkour, K., Cox, C., Weiss, B.
- Year:
- 1 992
- Bibliographic source:
- J. Appl. Toxicol. 12(3):193-197.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- mortality only recorded over 24 hours
- Principles of method if other than guideline:
- Based on the method of Litchfield and Wilcoxon (Exp Ther J, 96, 99, 1949). The purpose of the study was to assess the acute toxicity of ethanol, methanol and mixtures of the two (as typically found in denatured ethanol products). Only the information relating to ethanol is reported here.
- 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:
- - Name of test material (as cited in study report): ethanol
- Source: El Nasr Co, Cairo
- Analytical purity: Test substance was 99.8% ethanol and 0.1% methanol.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Ratus Norvegicus, albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Research Centre, Egypt
- Age at study initiation: Adults
- Weight at study initiation: 180 g +/-3g.
- Fasting period before study: 16hrs
- Diet: ad libitum (ex El Dabba Trade Co, Egypt)
- Water: ad libitum
- Other: virgin females
ENVIRONMENTAL CONDITIONS
- Temperature: 22 -26°C
- Photoperiod: 12 hour light/12 hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: no data but assumed undiluted.
- Details on oral exposure:
- Ethanol gavage was preceded by gum acacia gavage given 10 mins before dosing to reduce local irritation in stomach.
MAXIMUM DOSE VOLUME APPLIED: One dose per time period
- Exposure duration: not applicable. - Doses:
- 16, 17, 18, 19, 20, 21 and 22 ml/kg (selected on the basis of published information to range from non fatal in all animals to fatal in all animals)
- No. of animals per sex per dose:
- 8. Larger number used to improve precision.
- Details on study design:
- - Duration of observation period following administration: 24 hours
- Frequency of observations and weighing:
- Necropsy of survivors performed: Not reported
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 15 010 mg/kg bw
- 95% CL:
- > 14 450 - < 15 560
- Mortality:
- Individual times of death not given.
- Clinical signs:
- other: Clinical obserbations ranged from inebriation to gait disturbance and dose-related decrease in resonse to painful stimuli, respiratory depression and coma. Deaths were due to cardiorespiratory failure preceded by coma.
- Gross pathology:
- Gross and histopathological examination showed gastric mucosa with diffuse congestion and dilation of blood vessels but no hemorrhage or ulceration. All other tissues appeared normal.
- Other findings:
- - Potential target organs: Not reported
- Necropsy findings: Diffuse congestion of the gastric mucosa without gross haemorrhage or ulceration.
- Sex Comparison: not applicable.
Any other information on results incl. tables
Mortality
Dose (ml) | Mortality |
16 | 0/8 |
17 | 0/8 |
18 | 2/8 |
19 | 4/8 |
20 | 6/8 |
21 | 8/8 |
22 | 8/8 |
19 ml/kg converts to 15.01 g/kg bw. SD=0.23
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In an acute toxicity study in female rats using a relatively large number of animals over 7 closely spaced doses, an LD50 value of 14500 -15500mg/kg was obtained. Animals were only observed for a period of 24 hours, although it is unlikely that significant deaths would have occurred after this point due to the known toxicokinetics of metabolism. Those animals that died showed severe CNS effects with death due to cardiorespiratory failure that was preceded by coma.
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