Registration Dossier
Registration Dossier
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EC number: 206-017-1 | CAS number: 288-13-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Acceptable, well documented publication/ study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Liver Cell Necrosis in Rats After Prolonged Ethanol Ingestion Under the Influence of an Alcohol- Dehydrogenase Inhibitor
- Author:
- Lelbach W.K.
- Year:
- 1 969
- Bibliographic source:
- Experientia 25/8, 816-18
Materials and methods
- Principles of method if other than guideline:
- The LD50 was determined after a 24-hour fast with free access to tap-water.
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Pyrazole
- EC Number:
- 206-017-1
- EC Name:
- Pyrazole
- Cas Number:
- 288-13-1
- Molecular formula:
- C3H4N2
- IUPAC Name:
- 1H-pyrazole
- Details on test material:
- Pyrazole, easily soluble in water and alcohol (purchased from Messrs. D. Schuchardt, Munich), was used as 1% and 5% w/v aqueous solutions.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 205-220 g
- Housing: each housed in individual cages
- Diet: commercial standard solid diet (Altromin-R) ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: unspecified
- Doses:
- 840-1214 mg/kg
- No. of animals per sex per dose:
- 2 groups of 40 rats each
- Control animals:
- not specified
- Details on study design:
- The LD50 was determined after a 24-hour fast with free access to tap-water.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 010 mg/kg bw
Any other information on results incl. tables
The minimal lethal dose was 850 mg/kg. After single doses larger than 1000 mg/kg leading to a comatose state with death occurring within 12 -36 h, no liver cell alterations were seen microscopically; livers of rats dying 6 -11 days after 850 -1000 mg/kg showed extensive centrolobular necrosis with inflammatory reactions and appearance of fat ill surviving liver cells.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 (rat): 1010 mg/kg
- Executive summary:
The oral LD50 of the test substance was determined after a 24-hour fast with free access to tap-water. The minimal lethal dose was 850 mg/kg. Single doses larger than 1000 mg/kg lead to a comatose state with death occurring within 12 -36 hours with no liver cell alterations observed microscopically. Liver effects were observed in rats dying 6 -11 days after 850 -1000 mg/kg. The LD50 was 1010 mg/kg.
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