Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl propionate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Jun 2000 to 30 Jun 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate

EC Number:

272-805-7

EC Name:

3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate

Cas Number:

68912-13-0

Molecular formula:

C13H18O2

IUPAC Name:

3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoindenyl propionate

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: Charles Rover, Germany
- Weight at study initiation: 3.2 kg - 3.3 kg
- Housing: Individually caged in PPO cages (floor area 2576 cm square) with perforated floor
- Diet: Complete rabbit diet 'Altromin 2123' was available ad libitum
- Water: water (acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth) was available ad libitum
- Acclimation period: at least on week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL
- concentration: 100%
- 0.1 mL test material was placed in one eye of the rabbits and the lids were held together for 1 second

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

- day before testing (both eyes of animals)
- 1, 24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

four female rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: see table below. When Fluorescein was used the cornea reactions were scored both before and after the instillation of Fluorescein.

TOOL USED TO ASSESS SCORE:
- hand held inspection lamp fitted with white and UV-light and magnifying glass with 2x magnification
- examination was performed before and after instillation of fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- 1 hour: One hour after application one animal showed a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge different from normal. Another animal showed some conjunctival vessels definitely injected and a swelling above normal. The other two animals showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal.
- 24 to 72 hours: 24 hours after application of the test material some conjunctival vessels definitely injected were observed in three animals. One animal was free of signs of eye irritation. 48 hours and 72 hours after application all four animals were free of signs of irritation.

Any other information on results incl. tables

Mean individual scores are presented in the table below:

Mean scores 24, 48 and 72 hr	Animal 1	Animal 2	Animal 3	Animal 4
Cornea	0	0	0	0
Iris	0	0	0	0
Conjunctivae	0.33	0	0.33	0.33
Chemosis	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant

Remarks:

in accordance with EU CLP (EC No. 1272/2008 and its updates)

Conclusions:

In a GLP-compliant eye irritation test in accordance with OECDTG405, very slight signs of irritation were observed on the treated eyes. All effects were fully reversible after 48 hours. The test material was not irritating to the eyes under the conditions of this test.

Executive summary:

The potential of the test substance to cause eye irritation was determined according to OECD TG 405. Four New Zealand White female rabbits were exposed to 0.1 mL of the undiluted test article in one of the eyes. The other eye served as a control. The eyes were examined and the changes graded according to a numerical scale 1 hour, 24, 48, 72 hours after dosing. The animals showed very slight signs of irritation on the treated eyes. All effects were fully reversible within 72 hours. Based on these results, the test material does not have to be classified as irritating to eyes.