2(3H)-Furanone, dihydro-3-hydroxy-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

January 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Eye irritation was determined according to OECD Guideline 405 (Acute eye iiritation/corrosive).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxyoxolan-2-one

EC Number:

692-561-9

Cas Number:

19444-84-9

Molecular formula:

C4H6O3

IUPAC Name:

3-hydroxyoxolan-2-one

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

ANIMALS
-Number: three males.
-Strain and species: New Zealand White rabbits.
-Reason for selection of species: rabbit is a non-rodent species accepted by regulatory authorities for this type of study.
-Breeder: Hypharm, La Corbière, Roussay, France.
-Age/weight: at the beginning of the study, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2872 g (2821 g to 2959 g).
-Receipt: upon arrival at CIT, the animals were given a clinical examination to ensure that they are in good condition.
-Acclimation: the animals were acclimated for a period of at least 5 days before treatment of the dermal irritation study (CIT/Study No. 38035 TAL). As the animals were remained in the same study conditions, nobfurther acclimation period was necessary before the present study.
-Selection: just before treatment, the eyes of each animal were examined in order to use only animals without any signs of ocular irritation or lesions.
-Identification: the animals were individually identified with a metal ear-tag.

The conditions in the animal room were set as follows:
-temperature : 18 ± 3°C,
-relative humidity : 50 ± 20%,
-light/dark cycle : 12 h/12 h (7:00 - 19:00),
-ventilation : approximately 12 cycles/hour of filtered, non-recycled air.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as control.

Amount / concentration applied:

The test item was administered in the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the test item.
The right eye remained untreated and served as control.
A dosage-volume of 0.1 mL/animal was used.

Duration of treatment / exposure:

The eyes were not rinsed before 24-hour reading.

Observation period (in vivo):

1 hour, 24, 48 and 72 hours after administration of the test item

Number of animals or in vitro replicates:

3 Males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

>= 0 - <= 2.3

Max. score:

2.3

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

>= 0 - <= 1

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

>= 0.3 - <= 2.3

Max. score:

2.3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

>= 0 - <= 2.3

Max. score:

2.3

Reversibility:

fully reversible

Irritant / corrosive response data:

No unscheduled deaths occurred during the study.
No clinical signs were noted in any animals.
No ocular reactions were observed in the right untreated control eye.
Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
. chemosis: 0.0, 1.0 and 2.3; showing eye irritation in the third animal,
. redness of the conjunctiva: 0.3, 1.3 and 2.3; showing eye irritation in the third animal,
. iris lesions: 0.0, 0.0 and 1.0; showing no significant eye irritation,
. corneal opacity: 0.0, 0.0 and 1.7; showing no significant eye irritation.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the test item, 2-Hydroxy Gamma Butyro Lactone, was slightly irritant when administered by ocular route to rabbits.
However, the test item is not classified as irritating to the eye according to the criteria of CLP Regulation.