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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:
weight of evidence
Study period:
1985
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study performed similarly to OECD guideline 405 with deviations: lack of data about test substance, no details about housing conditions and scoring system different from guideline; study conducted in only one animal.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of data about test substance, no details about housing conditions and scoring system different from guideline; study conducted in only one animal.
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of test material : (2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol / 2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol
Molecular formula : C14H24O1
Smiles notation: OCC(=CCC(C(C(=C1)C)(C)C)C1)CC

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Nine weeks
- Weight at study initiation: 1.9 kg
- Housing: Housed individually in cages with wire mesh floor
- Diet: Certified pelleted commercial rabbit diet; ad libitum
- Water: Tap water; ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume with unit): 100 µL
Duration of treatment / exposure:
No washing was done
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
One male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No
- Time after start of exposure: Not applicable

SCORING SYSTEM:
CORNEA
Normal…0
Any change from normal, including slight dulling of corneal luster; 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 on folds…1
Severe congestion of iridial vessels or deepening on folds; loss of iridial reflex to light…2

Area of cornea or iris affected
Less than ¼ of area affected…1
Between ¼ and ½ of area affected…2
Between ½ and ¾ of area affected…3
Between ¾ and whole area affected…4

CONJUNCTIVAE
Redness (palpebral and bulbar conjunctivae and nictitating membrane)
Vessel normal…0
Some vessel definitely injected…1
Diffusion, crimson red, individual vessel 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

TOOL USED TO ASSESS SCORE: Macroscopical observations were performed using hand-held torch and corneal thickness was assessed using slit lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritant / corrosive response data:
- Loss of small area of corneal epithelium with slight corneal swelling and iritis; moderate conjunctivitis with copious discharge
- Irritation completely resolved by Day 7
Other effects:
None

Any other information on results incl. tables

Table 1: Daily observation of ocular reactions

 

Observation period

Corneal score

Conjunctive

Iris

Opacity

Area

% Swelling

Redness

Chemosis

Discharge

15 min.

-

-

-

1

0

 

-

Day 2

1

1

30

2

1

3

1

Day 3

1

1

0

1

1

1

0

Day 4

1

1

 

1

1

1

0

Day 5

1

1

 

1

0

0

0

Day 7

0

 

 

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Remarks:
Criteria used for interpretation of results: other: Annex VI to the Directive 67/548/EEC
Conclusions:
Based on the results obtained with one animal, the test item is classified as ‘R36 Irritating to eyes’ according to Directive 67/548/EEC and as ‘Irritating to eye (Category 2)’ according to CLP Regulation (EC) n° 1272/2008.
Executive summary:

In an eye irritation study conducted similarly to OECD guideline 405, one healthy male rabbit of the New Zealand White strain was exposed to 100 µL of undiluted test item in one of the eyes. The eyes were assessed for conjunctival responses 15 min after treatment and corneal, conjunctival and iridial responses were observed at 1, 2, 3, 4 and 6 days after treatment.

 

Instillation of the test item resulted in loss of small area of corneal epithelium with slight corneal swelling, slight iritis and moderate conjunctivitis with copious discharge. The irritation completely resolved within 6 days. Mean individual scores at 24, 48 and 72 hours after exposure for the animal were 1 for corneal score, 0.33 for iris score, 1.33 for conjunctivae score and 1 for chemosis score.

 

Based on the results obtained with one animal, the test item is classified as ‘R36 Irritating to eyes’ according to Directive 67/548/EEC and as ‘Irritating to eye (Category 2)’ according to CLP Regulation (EC) n° 1272/2008.