Registration Dossier
Registration Dossier
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EC number: 204-255-0 | CAS number: 118-48-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16.-21.12.1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
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:
- Method: BASF-Test, standard procedure
- GLP compliance:
- no
- Remarks:
- pre-GLP study
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:
- rabbit
- Strain:
- Vienna White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- A 50% aqueous suspension was applied to the test site.
- Duration of treatment / exposure:
- 1 minute, 5 minutes, 10 minutes, 20 hours
- Observation period:
- 8 days
- Number of animals:
- 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Other effects:
- The test substance was found to hydrolyse in water.
Any other information on results incl. tables
There were no symptoms in both animals after 1, 5 and 15 min. At the 24 -hour reading, a questionable edema (Draize score = 1) was observed at the dorsal skin treated for 20 hours and stayed for another day in both animals; no reaction was noted at any other treated skin site. The skin was normal at the 8 -day reading.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
A 50% suspension of the test substance in water was applied to the skin of rabbits for up to 20 hours under occlusive conditions. After 20 h exposure, questionable erythema (equivalent to mean Draize score 1.0) was observed at the 24 and 48 h reading in both animals, but were fully reversible within 8 days; slight edema was observed only at 24 hours after beginning of treatment at the dorsal skin of one animal (mean Draize score 0.33).
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