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Toxicological information

Skin irritation / corrosion

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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:
1971
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

Constituent 1
Chemical structure
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

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).