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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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