Phenethyl isobutyrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-02-26 to 2001-02-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl isobutyrate

EC Number:

203-116-1

EC Name:

Phenethyl isobutyrate

Cas Number:

103-48-0

Molecular formula:

C12H16O2

IUPAC Name:

2-phenylethyl 2-methylpropanoate

Test animals / tissue source

Species:

rabbit

Strain:

other: Little-russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: ad libitum, pelleted complete rabbit diet "Altromin 2123" from Altromin, 32791 Lage, Germany
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

The eyelids were gently held to gether for one second after instillation of the test material. The eyes were not washed out afterwards.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM:
Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after application of the test article all four animals showed slight symptoms (conjunctiva redness and chemosis were scored 1). After 24 hours one animal exhibited a conjunctiva with some vessels definitely injected. All animals were free of symptoms after 48 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was not irritating to the rabbits' eyes.

Executive summary:

An acute eye irritation study was conducted on 4 rabbits. 0.1 mL of the test material were therefore instilled in one eye, the other eye served as control. Eye reactions were scored 1, 24, 48 and 72 hours after treatment. The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal another three rabbits were included in the study. One hour after application of the test article all four animals showed slight symptoms (conjunctiva redness and chemosis were scored 1). After 24 hours one animal exhibited a conjunctiva with some vessels definitely injected. All animals were free of symptoms after 48 hours. The mean scores (24/48 and 72 hours) were 0 for cornea opacity, iris lesion and oedema and 0.33 for conjunctiva redness. Therefore, the test material was considered to be non-irritating to the eyes.