(3H)-benzofuran-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-06-29 to 1993-07-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: The left flank did not receive any test substance and served as control.

Amount / concentration applied:

A dose of 500 mg of the test substance in its original form was applied to a 6 cm2 hydrophilic gauze patch moistened with 0.5 ml of water for injections and this was then applied to the right flank of each animals.

Duration of treatment / exposure:

The test substance was held in contact with the skin for 4 hours. Any residual test substance was removed by means of a compress moistened with water for injections.

Observation period:

Cutaneous reactions were observed approximately 1, 24, 48 and 72 hours after removal of the dressing and then daily until day 13 in order to observe their reversibility.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 11 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Reversibility:

fully reversible within: 13 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Reversibility:

fully reversible within: 11 d

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

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

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 48 h

Other effects:

From days 4 to 12, a dryness of the skin was observed on the treated sites of three aninals and a temporary yellow colouration in one animal (1 h - 48 h). These effects were fully reversible within 13 d. No signs of tissular lesions on the whole thickness of the skin were noted.

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 erythema, oedema 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 cutaneous route in rabbits.

Executive summary:

The potential of the test substance, 2-COUMARANONE, to induce dermal irritation was evaluated in rabbits according to O.E.C.D. (No. 404, 12th May 1981) guidelines. The study was conducted in compliance with the Principles of Good Laboratory Practice Regulations.

A single dose of 500 mg of the test substance was prepared on a moistened compress, and then applied to a 6 cm2 clipped area of the skin of 3 male New Zealand White rabbits. The test substance was held in contact with the skin for 4 hours by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1, 24, 48 and 72 hours after removal of the dressing and then daily until day 13 in order to observe their reversibility. Any residual test substance was removed by means of a compress moistened with water for injections. The mean score of the values for erythema and oedema recorded for each animal after 24, 48 and 72 hours was calculated.

Very slight cutaneous reactions in 1 animal and marked in 2 animals were observed during at least 72 hours. These reactions consisted of an erythema (scores of 1 to 4) and an oedema (scores of 2 to 4). The erythema was reversible on day 10 and oedema on day 3. The mean scores for each animal were 1.0, 2.7 and 3.0 for erythema and 0.0, 0.7 and 1.0 for oedema. From days 4 to 12, a dryness of the skin was observed on the treated site. No signs of tissular lesions on the whole thickness of the skin were noted. On day 13, all the cutaneous reactions were reversible.

As the mean scores for erythema, oedema 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 cutaneous route in rabbits.