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Registration Dossier
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EC number: 200-578-6 | CAS number: 64-17-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976-02-26 to 1976-03-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD guideline 401.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- 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): 5% H2O in 95% Ethanol
- Molecular formula (if other than submission substance): C2H6O
- Molecular weight (if other than submission substance): not available
- Substance type: pure active substance
- Physical state: not available
- Analytical purity: not available
- Impurities (identity and concentrations): not available
- Composition of test material, percentage of components: not available
- Isomers composition: not available
- Purity test date: not available
- Lot/batch No.: not available
- Expiration date of the lot/batch: not available
- Stability under test conditions: not available
- Storage condition of test material: not available
- Other: specific gravity- 0.82 g/ml
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Cox CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not available
- Age at study initiation: not available
- Weight at study initiation: 199-215 g
- Fasting period before study: not available
- Housing: not available
- Diet (e.g. ad libitum): not available
- Water (e.g. ad libitum): not available
- Acclimation period: not available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not available
- Humidity (%): not available
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): not available
IN-LIFE DATES: From: 1976-02-26 To: 1976-03-19
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not applicable
- Amount of vehicle (if gavage): not applicable
- Justification for choice of vehicle: not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
MAXIMUM DOSE VOLUME APPLIED: 19.6 ml/kg
DOSAGE PREPARATION (if unusual): not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable - Doses:
- 8200, 9840, 11480 and 16070 mg/kg
- No. of animals per sex per dose:
- 10 animals total (5 male/5 female) at 8200, 9840, 11480 and 16070 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for observation and body weights were taken at initial and termination of the study
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight and mortalities - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10 470 mg/kg bw
- 95% CL:
- 9 720 - 11 380
- Mortality:
- 8200 mg/kg: 0/10
9840 mg/kg: 3 female animals/10
11480 mg/kg: 8 (5 female animals)/10
16070 mg/kg: 10 (5 female animals)/10 - Clinical signs:
- other: 8200 mg/kg: moderate decrease in motor activity and respiratory rate, moderate blanching, gripping and ataxia 9840 mg/kg: moderate decrease in motor activity and respiratory rate, moderate pupillary response moderate gripping and ataxia 11480 mg/kg: extre
- Gross pathology:
- No gross abnormalities were seen upon gross necropsy
- Other findings:
- - Organ weights: not available
- Histopathology: not available
- Potential target organs: not available
- Other observations: none
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 5% H2O in 95% Ethanol : OECD GHS: LD50= 10470 mg/kg (based on 95% active test material)
- Executive summary:
In a guideline acute oral toxicity study, the LD50 was determined to be 10470 mg/kgbw when dosed as a 95% solution in water.
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