Reaction mass of 2-methylbutyl acetate and pentyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

no guideline available

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:

Reaction mass of 2-methylbutyl acetate and pentyl acetate

EC Number:

908-918-1

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of 2-methylbutyl acetate and pentyl acetate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The animals are maintained on appropriate commercial diet and municipal water. Both are 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 hr

Observation period (in vivo):

Eyes are scored by the attached system 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 by the attached system 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:

other: 24, 48 and 72 hours

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:

other: 24, 48 and 72 hours

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:

other: 24, 48 and 72 hours

Score:

0.4

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 0.1 ml test substance applied

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.1

Max. score:

2

Reversibility:

fully reversible within: 48 hours

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.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met