Phthalide

Eye irritation

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1977

Materials and methods

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Approximately 50 mg of the test substance were applied to the conjunctival sac of one eye in 2 animals. The talcum-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 8 days afterwards. Findings were recorded on working days. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report usually describes findings after 1 and 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data have to be taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phthalide

EC Number:

201-744-0

EC Name:

Phthalide

Cas Number:

87-41-2

Molecular formula:

C8H6O2

IUPAC Name:

1,3-dihydro-2-benzofuran-1-one

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 applied: 50 mg
- Concentration: 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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: The original readings at 72 h are missing. Therefore, the values from the 48 h reading were used for the 72 h reading.

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: The original readings at 72 h are missing. Therefore, the values from the 48 h reading were used for the 72 h reading.

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: The original readings at 72 h are missing. Therefore, the values from the 48 h reading were used for the 72 h reading.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: The original readings at 72 h are missing. Therefore, the values from the 48 h reading were used for the 72 h reading.

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

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

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met