Butanoic acid, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Nov 2001 - 07 Feb 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

441-420-8

EC Name:

-

Cas Number:

113889-23-9

Molecular formula:

C14H20O2

IUPAC Name:

tricyclo[5.2.1.0²,⁶]dec-3-en-8-yl butanoate; tricyclo[5.2.1.0²,⁶]dec-4-en-8-yl butanoate

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: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed in suspended metal cages (environmental enrichment items were provided)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 - 18:00) and 12 hours continuous darkness

IN-LIFE DATES: From: 22 November 2001 To: 29 November 2001

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

Test substance was used as supplied

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): test substance was used as supplied

Duration of treatment / exposure:

Single treatment, no removal of test substance.
Immediately after placing 0.1 mL of the test material into the conjunctival sac of the right eye, the upper and lower eyelids were held together for about 1 second.

Observation period (in vivo):

Assessment of ocular damage/irritation was made after approximately 1 hour and 24, 48, 72 hours following treatment.

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
Not applicable, test substance was not removed.

SCORING SYSTEM: Draize Scale for Scoring Ocular Irritation;
1) The Conjunctivae are scored for: A) redness (0 - 3), B) Chemosis (0 - 4), C) Discharge (0 - 3). Total score = (A + B + C)x2, with a maximum score of 20.
2) The Iris is scored for: D) Values (0 - 2). Total score = Dx5, with a maximum score of 10.
3) The Cornea are scored for : E) Degree of Opacity (most dense ares used) (0 - 4) and F) Area of Cornea Involved (1 - 4). Total score = (E + F)x5, with a maximum score of 80.
The maximum tot score possible = 110.

TOOL USED TO ASSESS SCORE: Examination of eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.

Other effects:

Not applicable

Any other information on results incl. tables

Individual mean scores at 24, 48 and 72 hour after treatment:

Area	Mean scores (24, 48 and 72 hours) per animal number
	1	2	3
Cornea	0	0	0
Iris	0	0	0
Conjunctiva	0.33	0.33	0.33
Chemosis	0.33	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

in accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

Cyclobutanate causes very slight and reversible eye irritation, based on a eye irritation test according to OECD TG 405.

Executive summary:

In this study the ability of Cyclobutanate to induce eye irritation was studied in New Zealand White rabbit eyes in accordance with OECD 405 and EC Method B.5. The right eye of each rabbit was treated with 0.1 mL Cyclobutanate and the eyelids were held together for about one second immediately after treatment. This application was followed by a 72 hour observation period with typical observation points at 1 hour and 24, 48 and 72 hours. The left eye of each animal remained untreated and was used for control purposes. Eye irritation was scored according to the Draize classification.

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.