Cinnamyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.-21.08.1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Feb. 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", .Jan. 1997

Version / remarks:

Jan. 1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cinnamyl acetate

EC Number:

203-121-9

EC Name:

Cinnamyl acetate

Cas Number:

103-54-8

Molecular formula:

C11H12O2

IUPAC Name:

cinnamyl acetate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißleg
- Weight: 2.0 - 2.3 kg b.wt.
- Housing: individually in PPO cages (floor area: 2576 cm2) with perforated floor.
- Diet: pelleted complete rabbit diet "Altromin 2123" from Altromm, D-32791 Lage, Lippe; ad libitum
- Water: bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5.
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C
- Humidity: 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): cycle of 12 hours light (6 - 18h) and 12 hours darkness

DATES:
The experimental work was carried out between 17.08.1999 and 21.08.1999.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

1, 24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

4

Details on study design:

APPLICATIN OF TEST SUBSTANCE:
0.1 mL of the test article was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The lids were then gently held together for 1 second. The eyes were not rinsed after the treatment

EXAMINATION:
The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24h reading, fluorescein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours after the treatment.

SCORING SYSTEM: See 'Any other information on materials and methods'

TOOL USED TO ASSESS SCORE: fluorescein - UV-light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1, #2, #3, #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3, #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

One hour after application of the test article all animals showed some conjunctival vessels definitely injected and some swelling above normal, however, after 24 hours the animals did not show any signs of eye irritation.

Any other information on results incl. tables

Scores for ocular lesions:

After 1h, all rabbits had a score of 1 for conjunctival redness and for chemosis. All other scores were 0 at this time point.

After 24h, no more redness or chemosis was observed. All animals received scores of 0 on all examined parameters.

* individual mean score: only the scores from the readings after 24, 48 and 72 hours are included in the calculation of the individual mean scores.

Rabbit No/Weight per kg	Parameters	Individual mean score*
1581/2.3	cornea opacity	0.00
	iris	0.00
	conjunctiva redness	0.00
	conjunctiva chemosis	0.00
1595/2.0	cornea opacity	0.00
	iris	0.00
	conjunctiva redness	0.00
	conjunctiva chemosis	0.00
1596/2.2	cornea opacity	0.00
	iris	0.00
	conjunctiva redness	0.00
	conjunctiva chemosis	0.00
1594/2.0	cornea opacity	0.00
	iris	0.00
	conjunctiva redness	0.00
	conjunctiva chemosis	0.00

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

According to the CLP regulation the test item shall not be classified as eye irritating.

Executive summary:

The eye irritant effect of the test substance was investigated according to the OECD Guideline 405 and EEC Guideline B.5. The study is in compliance with GLP.

Four female albino rabbits were exposed to 0.1 mL of the test article in the left eye, while the other eye remained untreated and served as control.

The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing.

Very slight signs of irritation were observed on the treated eyes one hour after exposure. However, after 24 hours no signs of irritation were seen, indicating the reversible nature of the effects.

According to the CLP regulation the test item shall not be classified as eye irritating.