(2E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol

Eye irritation

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

(2E)-2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol

EC Number:

701-122-3

Cas Number:

106185-75-5

Molecular formula:

C14H24O

IUPAC Name:

(2E)-2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 2 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

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.