Phenethyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline-comparable study with limited methodological detail but sufficient for the purposes of hazard identification and classification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Version / remarks:

Study pre-dates introduction of the formal guideline

Principles of method if other than guideline:

Three rabbits treated by ocular instillation according to the method developed by Draize and published by the Association of Food and Drug Officials of the United States as "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
0.1 mL of the test substance was instilled into the right eye.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl acetate

EC Number:

203-113-5

EC Name:

Phenethyl acetate

Cas Number:

103-45-7

Molecular formula:

C10H12O2

IUPAC Name:

2-phenylethyl acetate

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye acted as a concurrent control for each treated rabbit.

Amount / concentration applied:

0.1 ml instilled into right eye of each rabbit

Duration of treatment / exposure:

The exposure was not limited by a wash-out for the treated eye. Potential continuous exposure was monitored for up to 7 days.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Three rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information

SCORING SYSTEM: standard Draize assessment

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein : No information

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

not fully reversible within: 7 day observation period

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.89

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Instillation of phenyl ethyl acetate into the right eye of three rabbits resulted in persistent corneal, iridial and conjunctival reactions that had not resolved at termination on Day 7.
The mean scores for the ocular parameters over the 24 to 72 hour timepoints for corneal, iridial and conjunctival reactions were lower than the classification thresholds but the persistence of reactions requires classfication of phenylethyl acetate as R41 Eye Irritant.

Executive summary:

In a three rabbit ocular irritation assessment, phenylethyl acetate elicited a degree of corneal opacity and some iritis together with conjunctival redness and swelling. Although none of the individual parameter mean scores would warrant classification of the test substance, the persistence of the reactions to termination with no signs of resolution warrants classification as an eye irritant (Category 1) according to CLP. H318 Causes serious eye damage.