Isopentyl acetate

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:

other: information on methodology and results is acceptable in quality and extent; study was conducted prior to GLP and test guidelines

Justification for type of information:

Reference to CSR in section 13.1 for read-across justification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Eye irritation potential was examined by placing 0.1 ml of primary amyl acetate into the eye of 6 rabbits. Eyes were examined at various times for 7 days after dosing.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Primary Amyl Acetate (mixture of n-pentyl acetate and 2-methylbutyl acetate)

IUPAC Name:

Primary Amyl Acetate (mixture of n-pentyl acetate and 2-methylbutyl acetate)

Details on test material:

Clear, non-viscous liquid. Charge No: 475010-135-500564.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The animals were maintained on appropriate commercial diet and municipal water. Both were available ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL and 0.01 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

Eyes are scored at one hour, approximately 6 hours, one day, 2 days and 3 days after dosing.

Number of animals or in vitro replicates:

Six eyes are dosed per test volume.

Details on study design:

Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored at one hour, approximately 6 hours, one day, 2 days and 3 days after dosing. Additional readings are made if necessary. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no effects observed

Remarks on result:

other: 0.1 mL test substance applied

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no effects observed

Remarks on result:

other: 0.1 mL test substance applied

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: 0.1 mL test substance applied

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

2

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: 0.1 mL test substance applied

Irritant / corrosive response data:

In 6 rabbit eyes, doses of 0.1 ml produced minor conjunctival irritation, but no corneal injury or iritis. Slight conjunctival irritation persisted in one eye through 3 days. At 7 days, all eyes were normal. Instillation of 0.01 ml resulted in slight conjunctival irritation in 6 eyes within one hour. Four eyes remained irritated at 6 hours, but only one had slight conjuncival irritation at 24 hours. Very slight irritation persisted in this eye through 3 days.

Other effects:

No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Moderate conjunctival irritation, with no involvement of the cornea or iris, resulted from instillation of 0.1 mL primary amyl acetate into rabbit eyes. Minor, transient conjunctival irritation was observed following doses of 0.01 ml primary amyl acetate. No classification for eye irritation is required according to EU criteria based on the results of this study.

Primary amyl acetate consists of N-pentyl acetate and 2-methylbutyl acetate which are structural isomers of isopentyl acetate. Based on this molecular similarity it is assumed that isopentyl acetate will exhibit an equal or similar effect in respect of eye irritation and will accordingly not be classified as eye-irritating.

Executive summary:

The eye irritation potential was examined with rabbits. Moderate conjunctival irritation, with no involvement of the cornea or iris, resulted from instillation of 0.1 mL primary amyl acetate into rabbit eyes. Minor, transient conjunctival irritation was observed following doses of 0.01 mL primary amyl acetate.