Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1977

Materials and methods

Principles of method if other than guideline:
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalide
EC Number:
201-744-0
EC Name:
Phthalide
Cas Number:
87-41-2
Molecular formula:
C8H6O2
IUPAC Name:
1(3H)-Isobenzofuranone
Details on test material:
- Name of test material (as cited in study report): Phthalid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.08 and 3.26 kg

Test system

Vehicle:
water
Controls:
other: adjacent eye served as talcum-treated control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): 80 %


Duration of treatment / exposure:
8 days (eyes were not washed out)
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 h- 48 h - 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: 72 h reading is missing

Any other information on results incl. tables

Findings: animal 1/animal 2:

 Time  Opacity  Iritis  Erythema  Chemosis
 1 h 0/0  0/0 1/1 2/2
 24 h 1/0  0/0 2/2 1/1
 48 h 1/0  0/0 1/1 0/0
 72 h -/- -/- -/- -/-
 8 d 0/0 0/0 0/0 0/0

Mean values over 24h and 48h (72h readings are missing):

Animal1: Opacity: 1; Iritis: 0; Erythema: 1.5; Chemosis: 0.5;

Animal2: Opacity: 0; Iritis: 0; Erythema: 1.5; Chemosis: 0.5;

The application of the test substance caused slight corneal opacity, slight to moderate erythema and chemosis. All effects were reversible within the 8 day observation period.

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information