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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 June 2000 - 30 June 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

Principles of method if other than guideline:

not applicable

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:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yl propionate and 3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-6-yl 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 cm2) 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°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light): cycle of 12 hours light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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 (if done): 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 inspectio lamp fitted with white and UV-light and magnifying glass woth 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:

animal: 2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 3, and 4

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

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 sweling above normal. The other two animals showed some conjunctival vessels definitely injected, a swelling above normal and a discharge different from normal.
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.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant

Remarks:

according to EU CLP (EC 1272/2008 and its amendments)

Conclusions:

In an eye irritation test in accordance with OECD405, 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 Cyclaprop to cause eye irritation was determined according to OECD guideline 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 examinated and the changes graded according to a numerical scale one hour, 24, 48, 72 hours after dosing. The animals showed very slight signs of irritation on the treated eyes. Mean corneal opacity, chemosis, and iris scores at the 24, 48, and 72 hour time point were 0 in all animals. Mean conjunctivae score was 0.33 in three animals and 0 in one animal. The effects seen in the one animal was reversible within one day. It is concluded that Cyclaprop is not an eye iritant.