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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 February 1985 to 03 April 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The rabbit eye irritation test according to test method No. OCTM05.01 dated 4.2.82 but with the following modifications:
- Treatment groups of the test material were diluted in Tween 80 (normally 10 and 50% dilutions) were omitted in this test.
- Only one animal was treated.
The study was conducted in accordance with S.O.P. 013
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3a,4,5,6,7,7a-hexahydro-5-methoxy-4,7-methano-1H-indene
EC Number:
258-296-4
EC Name:
3a,4,5,6,7,7a-hexahydro-5-methoxy-4,7-methano-1H-indene
Cas Number:
53018-24-9
Molecular formula:
C11H16O
IUPAC Name:
3a,4,5,6,7,7a-hexahydro-5-methoxy-4,7-methano-1H-indene
Test material form:
liquid
Details on test material:
- Appearance: colourless

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Commercial Supplier
- Age at study initiation: 9 weeks old
- Weight at study initiation: 2.3 kg
- Housing: animals were housed individually in cages with wire-mesh floors
- Diet: certified pelleted commercial rabbit diet ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 µL
- Concentration: undiluted

Duration of treatment / exposure:
The test material was applied to the conjunctival sac formed by gently pulling the lower eyelid away from the eyeball. After treatment the eye was closed and the eyelids released.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
1
Details on study design:
- Eyes were examined before application of the test material and at daily intervals afterwards with a slit lamp and corneal swelling was measured.
- Animals were observed carefully during and immediately after treatment for evidence of pain or discomfort. If excessive or persistent the substance was immediately washed out with copious quantities of physiological saline
- The eye was examined 15 minutes after treatment and thereafter at 2, 3, 4, 5 and 8 days and graded for corneal, conjunctival and iridial damage.


SCORING SYSTEM:

Cornea:
Normal = 0
Any change from normal, including slight dulling of corneal lustre = 0.5
Scattered or diffuse areas of opacity, or loss of corneal epithelium. Iris clearly visible = 1
Easily discernible, greyish, translucent areas, details of iris slightly obscured = 2
Grey-white areas, no details of iris visible, size of pupil barely discernible = 3
Complete corneal opacity, iris not discernible = 4

Iris
Normal = 0
Any divergence from normal, congestion of iridial vessels, deepening of folds = +
Severe congestion of iridial vessels or deepening of folds. Loss of iridial reflex to light = ++

Area of cornea or iris affected
Less than 1/4 of area affected = 1
Between 1/4 and 1/2 of area affected = 2
Between 1/2 and 3/4 of area affected = 3
Between 3/4 and whole area affected = 4

Conjunctivae
Redness (palpebral and bulbar conjunctivae and nictitating membrane)
Vessels normal = 0
Some vessels definitely injected = 1
Diffuse, crimson red, individual vessels not easily discernible = 2
Diffuse, beefy red = 3

Chemosis
No swelling = 0
Any swelling above normal = 1
Obvious swelling with partial eversion of eyelids = 2
Swelling with lids about half closed = 3
Swelling with lids more than half closed = 4

Discharge
No discharge = 0
Any discharge different from normal = 1
Discharge with moistening of lids and hairs just adjacent to the lids = 2
Discharge with moistening of lids and considerable area round eye = 3

Pannus

Healing
The insertion of 'N' as a score of corneal opacity denotes that the whole eye had returned to normal on the day indicated.

Corneal Swelling
Corneal thickness is measured with a slit-lamp 24 hours after treatment and thereafter at daily intervals until the thickness has returned to its pretreatment value. Slit-lamp readings are recorded in the Eye Treatment Book and the percentage corneal swelling is calculated from:
corneal swelling = (corneal thickness on day of measurement /corneal thickness before treatment) -1 x 100

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
One rabbit only was treated. The eye subsequently showed extensive loss of corneal epithelium with moderate corneal swelling and iritis. Conjunctivitis was moderate. The eye had healed normally by day 8. The test material is a moderate eye irritant at 100 μL dosage.

Any other information on results incl. tables

Table 1: Summary of Observations for the Test Material Treated Animal

Observations

Discomfort

Conjunctival Reactions

Iritis

Pannus

Maximum Corneal Opacity (Max. 4)

Maximum Corneal Swelling

Yes

Yes

Yes

No

1

Moderate

(46 – 80 %)

Table 2: Daily Observations

Animal

Region of Eye

Day

15 min

2

3

4

5

8

1

Cornea

Opacity

-

1

0.5

0.5

0.5

N

Area

-

1

1

1

1

-

Swelling (%)

-

71

15

0

-

-

Conjunctivae

Redness

2

2

2

1

1

0

Chemosis

2

2

1

1

0

0

Discharge

-

1

0

0

0

0

Iris

-

+4

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of this study the test material was considered to be a moderate eye irritant.
Executive summary:

The eye irritation potential of the test material was examined using a New Zealand White rabbit.

The test material was applied to the conjunctival sac formed by gently pulling the lower eyelid away from the eyeball. After treatment the eye was closed and the eyelids released.

One rabbit only was treated. The eye subsequently showed extensive loss of corneal epithelium with moderate corneal swelling and iritis. Conjunctivitis was moderate. The eye had healed normally by day 8.

Under the conditions of this study the test material was considered to be a moderate eye irritant.