Registration Dossier
Registration Dossier
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EC number: 202-509-5 | CAS number: 96-48-0
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:
- other: Acceptable, well-documented report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 960
- Report date:
- 1960
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- BASF-Test. See details in remarks on material and methods.
- GLP compliance:
- no
Test material
- Reference substance name:
- γ-butyrolactone
- EC Number:
- 202-509-5
- EC Name:
- γ-butyrolactone
- Cas Number:
- 96-48-0
- Molecular formula:
- C4H6O2
- IUPAC Name:
- dihydrofuran-2(3H)-one
- Details on test material:
- - Name of test material (as cited in study report): γ-Butyrolacton
- Physical state: colorless liquid
- Analytical purity: 99.5 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Schmitt-Fischer-Rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 129 - 218 g (mean), female: 141 - 188 g (mean)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 and 10 % - Doses:
- 1600, 1250, 800 and 200 ml/kg bw = 1808, 1413, 904 and 226 mg/kg bw (coversion in mg/kg bw is based on the density of 1.13 g/cm3)
- No. of animals per sex per dose:
- 1808, 1413, 904 mg/kg bw: 5
226 mg/kg bw: 3 females and 2 males - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 582 mg/kg bw
- Remarks on result:
- other: the conversion mg/kg bw is based on the density of 1.13 g/cm3
- Mortality:
- See details in remarks on results.
- Clinical signs:
- other: Staggering, abdominal and lateral position, narcosis.
- Gross pathology:
- 1808 mg/kg bw: animals showed slight reddening of the small intestine and pale livers or patterns on the liver. One animal of the 1413 mg/kg bw showed myocarditis.
Any other information on results incl. tables
Mortality:
| Dose (mg/kg bw) | Gender | 1 h | 24 h | 48 h | 7 days | 14 days |
| 1808 | male | 0/5 | 4/5 | 4/5 | 4/5 | 4/5 |
| 1808 | female | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 |
| 1413 | male | 0/5 | 3/5 | 3/5 | 3/5 | 4/5 |
| 1413 | female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| 904 | male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| 904 | female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| 226 | male | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 |
| 226 | female | 0/2 | 0/2 | 0/2 | 0/2 | 0/2 |
The test substance caused toxicity (including mortality) in a dose dependent manner, after a single ingestion.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information According to Regulation (EC) 1272/2008 Criteria used for interpretation of results: EU
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