(3H)-benzofuran-2-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-07-07 to 1993-07-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well perforemd OECD and GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3H)-benzofuran-2-one

EC Number:

209-052-0

EC Name:

(3H)-benzofuran-2-one

Cas Number:

553-86-6

Molecular formula:

C8H6O2

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): 2-COUMARANONE
- Physical state: solid
- Lot/batch No.: D 2008
- Storage condition of test material: in a plastic flask, at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye, which remained untreated, served as a control.

Amount / concentration applied:

A single dose of 100 mg of the test substance in its original form was placed into the conjunctival sac of the left eye.

Duration of treatment / exposure:

The eyes were not rinsed after administration of the test substance.

Observation period (in vivo):

The eyes were examined approximately 1, 24, 48 and 72 hours after administration of the test substance.
As there was persistent ocular irritation after 72 hours, the observation period was extended to a maximum of 7 days (until day 8) in order to determine the progress of the lesions and their reversibility.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Reversibility:

fully reversible within: 8 d

Results 3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Reversibility:

fully reversible within: 6 d

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Reversibility:

fully reversible within: 8 d

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 7 d

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48 d

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no signs of irritation (cornea) at any time

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no signs of irritation (cornea) at any time

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 72 h

Other effects:

In 3 animals, a discharge was noted between from day 1 to day 5.
On day 8, all ocular reactions were reversible.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

As the mean scores for chemosis for 2 out of the 3 animals reached the criteria values for irritation,
under these experimental conditions, the test substance, 2-COUMARANONE, was considered
as irritant when administered by ocular route in rabbits.

Executive summary:

The ocular irritation that could be induced by the test substance, 2-COUMARANONE, was evaluated in rabbits according to O.E.C.D. (No. 405, 24th February 1987) guidelines. The study was conducted in compliance with the Principles of Good Laboratory Practice Regulations.

As the test substance had an irritant effect when administered by cutaneous route, a preliminary assay was conducted initially on 1 animal. As the test substance revealed no very irritant effects, the study was continued using 2 other animals. A single introduction of 100 mg of the test substance in its original form was placed into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. The eyes were not rinsed after administration of the test substance. Ocular reactions were observed approximately 1, 24, 48 and 72 hours after the administration and then daily in order to observe their reversibility. The mean score of the values recorded for each animal after 24,48 and 72 hours was calculated.

After treatment, moderate and marked ocular reactions were observed. A moderate (1 animal) or marked (2 animals) chemosis was noted on the conjunctivae during 48 hours. Chemosis was reversible after 1 week. A moderate redness of the conjunctivae persisted during several days. A congestion of the iris and a slight corneal opacity which were reversible after 72 hours were also recorded. On day 8, all ocular reactions were reversible.

As the mean scores for chemosis for 2 out of the 3 animals reached the criteria values for irritation, under these experimental conditions, the test substance, 2-COUMARANONE, was considered as irritant when administered by ocular route in rabbits.