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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16.-24.12.1970
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

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 / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of test animals
Amount / concentration applied:
50 µL
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 5 d
Remarks on result:
other: see table for details
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48 h
Score:
1.25
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: hemorrhage was observed in both animals after 24 and 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Readings

Animal

Cornea

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

1

1

1

2

1

1

2

24 h

1

1

2

2

hemorrhage

2

0

1

1

hemorrhage

48 h

1

1

1

0

hemorrhage

2

1

1

0

hemorrhage

5 d

1

0

1

0

2

0

1

0

8 d

1

0

0

0

2

0

1

0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Executive summary:

The undiluted test substance was instilled into the eye of rabbits without rinsing and produced marked irritation. Irritation was not completely reversible within 8 days.