Octahydro-2H-1-benzopyran-2-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 April, 1980 - 29 May, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

no details on purity, no details on animal housing and environmental conditions

Principles of method if other than guideline:

Modified Federal Hazardous Substances Labelling Act Method.

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

Octahydro-2H-1-benzopyran-2-one

EC Number:

224-623-4

EC Name:

Octahydro-2H-1-benzopyran-2-one

Cas Number:

4430-31-3

Molecular formula:

C9H14O2

IUPAC Name:

octahydro-2H-1-benzopyran-2-one

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Morton

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Morton
- Age at study initiation: 8 weeks
- Weight at study initiation: 1.9 kg

ENVIRONMENTAL CONDITIONS
No data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each animal remained untreated and served as the reference control.

Amount / concentration applied:

Amount applied: 0.1 mL

Duration of treatment / exposure:

Single instillation on Day 1

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

1 female

Details on study design:

STUDY DESIGN
The test material was applied undiluted in 1 animal.

TREATMENT
The substance was applied to one eye of a rabbit by gently pulling the lower lid away from the eye ball and placing 0.1 mL in the sac so formed. Test and control eye were pre-treated with corneal anaesthetic.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Irritation:
The eyes were examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage. Eyes were examined before application of materials and at daily intervals afterwards with a slit lamp and corneal swelling is measured.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean)

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

The substance caused a moderate corneal opacity affecting all the cornea, with associated corneal swelling. The animal also had slight conjunctivitis and discharge, with purvulent exudate in the conjuctival folds. The corneal opacity effects (max. score 1) were not fully reversible within 21 days. The conjunctival redness effects (max. score 1) was fully reversible within 8 days. Chemosis (max. score 1) was observed but fully reversible within 4 days.
The animal developed pannus at day 8 which was visible at the end of the test at 21 days, associated with a persistent opacity.

Any other information on results incl. tables

Ocular Irritant response data (for the undiluted test substance)

	Time after administration
	15 minutes	24 hours	48 hours	72 hours
Cornea score (opacity)	-	1	1	1
Iris score	-	0	0	0
Conjunctivae score (redness)	1	1	1	1
Chemosis score	1	1	1	1

Applicant's summary and conclusion

Interpretation of results:

other: Serious eye damage, Category 1

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

In an eye irritation study with one female rabbit, performed equivalent to OECD 405 guideline, irritation was observed. Based on the results of this study, the substance is considered an eye irritant.

Executive summary:

The substance was tested in an eye irritation test in one female rabbit equivalent to OECD 405 guideline. The substance caused a moderate corneal opacity affecting all the cornea, with associated corneal swelling. The animal also had slight conjunctivitis and discharge, with purvulent exudate in the conjuctival folds. The corneal opacity effects (max. score 1) were not fully reversible within 21 days. The conjunctival redness effects (max. score 1) was fully reversible within 8 days. Chemosis (max. score 1) was observed but fully reversible within 4 days. The animal developed pannus at day 8 which was visible at the end of the test at 21 days, associated with a persistent opacity. The results showed that the substance is considered to be severe irritating to eyes.