Registration Dossier
Registration Dossier
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EC number: 202-603-6 | CAS number: 97-72-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- reporting details
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isobutyric anhydride
- EC Number:
- 202-603-6
- EC Name:
- Isobutyric anhydride
- Cas Number:
- 97-72-3
- Molecular formula:
- C8H14O3
- IUPAC Name:
- isobutyric anhydride
- Details on test material:
- - Physical state: liquid
no further data provided
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: male: 318g; female: 223g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 - 31.6%
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg - Doses:
- 10000, 6810, 4640, 3160 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: before substance application and on day 4 and day 7 after application. Observations: daily
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 7 700 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Mortalities were seen at all doses except for the low dose group
- Mortality:
- At the highest dose (10000mg/kg) all animals died within 48 hours. At 6810 mg/kg 3 of 5 female rats died within 24 hours and 1 male rat died after 7 days of application. At 4640 mg/kg 1 of 5 female rat died after 7 days. At the lowest dose no animal died within the observation time of 14 days.
- Clinical signs:
- other: In all dose groups in the first hours after treatment were dyspnae, apathy and staggering found. In the higher dose groups (except lowest dose group) abdominal position, tremor, opisthotonus, diarrhoe, exsiccose, lacrimation and salivation were found.
- Gross pathology:
- animals found dead: heart: acute dilatation and hyperemia; stomach: dilated, strong intravascular injection, substance induced mucosal malacia as well as bloody ulceration in the glandular stomach; intestine: partly atonic
scheduled sacrificed animals: stomach: agglutination of the gastro-oesophageal vestibule.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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