Ethanol

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

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

Test material information

Constituent 1

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

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.