Cinnamomum zeylanicum, ext.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

publication

Title:

The Comparative Respiratory Irritation Potential of Fourteen Fragrance Raw Materials

Author:

William R. Troy

Year:

1977

Bibliographic source:

Thesis

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Less observation time points: Not at 1h after exposure, nor at 14 and 21 days for reversibility effects Extra observation time point at 4 days. Grading of reactions is similar, but with different calculation method.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

1

Reference substance name:

Eugenol

EC Number:

202-589-1

EC Name:

Eugenol

Cas Number:

97-53-0

Molecular formula:

C10H12O2

IUPAC Name:

4-allyl-2-methoxyphenol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Peter J. flinn Rabbitry; Albany, New York
- Housing: individually in stainless steel cages having a wire mesh floor 16"x 19". The rack was of self-flushing variety.
- Diet: Tekklad Rabbit Feed ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): lighting cycle (probably 12 / 12)

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1mL

Observation period (in vivo):

Seven days.
Time points on 24h, 48h, 72h, four days and seven days.

Number of animals or in vitro replicates:

six female rabbits

Details on study design:

SCORING SYSTEM:
(1) Cornea
A. Opacity degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse area, details of iris clearly visible 1
Easily dicernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4
B. Area of cornea involved
One quarter (or less) but not zero 1
Greaters than one quarter, but less than half 2
Greater than half but less than three quarters 3
Greater than three quarters, up to whole area 4

A x B x 5 Total maximum = 80

(2) Iris
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these 2

A x 5 Total maximum = 10

(3) Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels noit easily discernible 2
Diffuse beefy red 3
B. Chemosis
No swelling 0
Any swelling above normal (including nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4
C. Discharge
No discharge 0
Any amount different from normal (does not include small amount abserved in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3

(A + B + C) x 2 Total maximum = 20

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

24 h

Score:

54

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

48 h

Score:

27

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

72 h

Score:

20

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 4d

Score:

14

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

7 d

Score:

3

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The substance is an eye irritant in the eye irritation test (OECD guideline 405). Based on these results, the test substance needs to be classified in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

The potential for eye irritation following exposure to eugenol was assessed in 6 female rabbits (0.1 mL of undiluted eugenol). Observations were carried out at regular intervals over 7 days following exposure. Eugenol appeared to affect the rabbit eyes 1 day following application; however, the effects were reversible as the eye irritation grades decreased over the 7-day observation period.

This eye irritation information for eugenol is based on the standard Draize scale which has an overall score based on a 110 point rating scale. This rating scale is not directly compatible with Regulation (EC) No 1272/2008, Annex I section 3.3 classification criteria. However, based on guidance from various agencies, eugenol appears to be severely irritating in the first 24 hours post-exposure, moderately to mildly irritating after 24 and 72 hours post-exposure, and practically non-irritating after 7 days post-exposure.