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Toxicological information

Acute Toxicity: oral

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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:
reference to same study
Reason / purpose:
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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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: extreme decrease in motor activity and respiratory rate, moderate pupillary response moderate to slight gripping and ataxia
16070 mg/kg: moderate decrease in motor activity and respiratory rate, moderate pupillary response slight blanching, abdominal gripping and ataxia
Body weight:
Gain in body weights were observed in surviving animals
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.