Registration Dossier
Registration Dossier
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EC number: 204-255-0 | CAS number: 118-48-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16.-23.12.1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Principles of method if other than guideline:
- BASF-Test.
Method comparable to OECD guideline 401. - GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4H-3,1-benzoxazine-2,4(1H)-dione
- EC Number:
- 204-255-0
- EC Name:
- 4H-3,1-benzoxazine-2,4(1H)-dione
- Cas Number:
- 118-48-9
- Molecular formula:
- C8H5NO3
- IUPAC Name:
- 4H-3,1-benzoxazine-2,4(1H)-dione
- Details on test material:
- Isatosäureanhydrid (Isatoic anhydride); no further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Gassner
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2, 16 and 30%
- Amount of vehicle (if gavage): 10 ml/kg bw
According to the authors, the test substance is hydrolysed by water.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
No further data. - Doses:
- 200, 1600, 3200, 6400 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of weighing: first and last day of experiment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 400 mg/kg bw
- Mortality:
- 1 male of the highest dose group after 7 days
- Clinical signs:
- other: dyspnea
- Gross pathology:
- no pathological findings
Any other information on results incl. tables
Only one male animal of the highest dose group (6400 mg/kg) was found dead after 7 days. The only symptoms found were dyspnea right after the application of 6400 and 3200 mg/kg and crouch position in the morning of the second day in the 1600 mg/kg group. On all the other days the animals did not show any symptoms and also pathology of the dead and sacrificed animals was without relevant findings.
Applicant's summary and conclusion
- Executive summary:
LD50 > 6400 mg/kg bw after 7 days
Groups of rats were administered a preparation of the test substance in aqueous CMC and were observed for 7 days. The test substance was found to hydrolyse in water. Clinical signs of toxicity were limited to dyspnea. No pathological abnormalities were noted.
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