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EC number: 204-255-0 | CAS number: 118-48-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data are given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
- Principles of method if other than guideline:
- internal standard procedure
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- fixed dose procedure
- Limit test:
- yes
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:
- Isatoic anhydride, technical grade; no further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Kirchborchen
- Age at study initiation: no data
- Weight at study initiation: 160 - 210 g
- Fasting period before study: no data
No further data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: acetone /oil (1:10)
- Details on dermal exposure:
- Five male rats were used. The dorsal skin was shaved. One day later, a 25% solution of the test substance in an acetone / oil vehicle (1:10) was applied to the skin at a dose level of 500 mg/kg bw. A paper collar was used for each animals to prevent them from licking off the applied material. The test material was kept in contact with the skin for 7 days.
- Duration of exposure:
- 7 days
- Doses:
- 500 mg/kg bw
- No. of animals per sex per dose:
- 5 males
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs - Statistics:
- LD50 was calculated in accordance with Litchfield and Wilcoxon (1949). J Pharm Exp Ther 96: 99.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: No clinical signs of toxicity were noted.
- Gross pathology:
- no data
Applicant's summary and conclusion
- Executive summary:
A 25% solution of the test substance in an acetone / oil vehicle (1:10) was applied to the shaved dorsal skin of each of 5 male Wistar rats a dose level of 500 mg/kg bw. A paper collar was used for each animals to prevent licking of the applied material. The test article was kept in contact with the skin for 7 days. No deaths and no signs of intoxication were observed. LD50 was found to be > 500 mg/kg bw.
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