Allyl hexanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted under GLP-conditions in accordance with the official OECD Guideline No 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Allyl hexanoate

EC Number:

204-642-4

EC Name:

Allyl hexanoate

Cas Number:

123-68-2

Molecular formula:

C9H16O2

IUPAC Name:

allyl hexanoate

Constituent 2

Reference substance name:

123-68-3

IUPAC Name:

123-68-3

Details on test material:

- Physical state: liquid
- Storage condition of test material: cool and dry

Test animals / tissue source

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Möllegaard Breeding And Research Centre A/S, Ejby, Lille Skensved, Denmark
- Age at study initiation: not reported
- Weight at study initiation: 2.3 to 2.8 kg
- Housing: caged individually in PPO cages (area 2580 cm2) with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet Altromin 2123 from Altromin, Lage/Lippe, Germany ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 7 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL of the neat test substance

Duration of treatment / exposure:

single administration; after 24 hour reading Fluorescein was instilled and treated eye was washed with 20 mL 0.9% sodium chloride solution

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

4

Details on study design:

REMOVAL OF TEST SUBSTANCE
- substance was not removed from the treated eye

SCORING SYSTEM:
see section "Any other information on materials and methods"

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Fluorescein was instilled after 24 hours, eyes were rinsed with 20 mL 0.9% sodium chloride solution and were examined using UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean of ratings at 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean of ratings at 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean of ratings at 24, 48 and 72 hours

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean of ratings at 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after application of the test substance all animals showed weak conjunctival effects with conjunctival vessels being definitely injected. After 24, 48 and 72 hours all four animals were free of any signs of eye irritation.

Other effects:

No other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not irritating to the rabbit eye.

Executive summary:

The potential for eye irritation was tested for allyl caproate (allyl hexanoate) in a GLP study according to OECD guideline No. 405. Four healthy SPF albino rabbits (Mol:Russian) weighing 2.3 to 2.8 kg were used in the study. The day before testing both eyes of the animals were examined before and after the instillation of Fluorescein to ensure there were no defects or irritation. The next day an aliquot of 0.1 mL of the neat substance was placed in the left eyes of the animals by gently pulling the lower lid away from the eyeball. The lids were then gently hold together for one second. The right eye remained untreated and served as control. The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours later. After a first reading at 24 hours Fluorescein was instilled and the treated eye was rinsed with 20 mL 0.9% sodium chloride solution. Then the eye was examined again using UV-light to detect possible corneal damage. Further gradings were done after 48 and 72 hours after treatment. All animals showed slight conjunctival effects at the examinations occurring 1 after treatment. All four animals were free of any signs of ocular irritation at the gradings following 24, 48 and 72 hours after treatment. On the basis of these observations it was concluded that the substance is non-irritating to the rabbit eye.