Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19.02.2018 to 22.02.2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate

EC Number:

261-118-8

EC Name:

Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate

Cas Number:

58096-47-2

Molecular formula:

C16H26O2

IUPAC Name:

decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate

Test material form:

liquid

Test animals / tissue source

Species:

cattle

Strain:

other: Not applicable

Details on test animals or tissues and environmental conditions:

The bovine eyes were procured from local abattoir and transported in a jar containing Hank’s Balanced Salt Solution (HBSS) and penicillin-streptomycin (100 IU & 100 µg/mL) in an ice box.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

A volume of 0.75 mL of negative control (distilled water), positive control (acetone) and test item (Clovanyl-3-Formate (CARYOLAN) was applied to the corneas by means of closed chamber method.

Duration of treatment / exposure:

• All the corneas were placed in a horizontal position (anterior side up) in the incubator at 32 (±1) ºC.
• After ten minutes, the test substances from anterior chambers were removed and washed three times with EMEM containing phenol red.
• Finally, the anterior chamber was rinsed with EMEM without phenol red. Both the chambers were filled with fresh EMEM and further incubated at 32 (±1) ºC for 2 hours before measuring the final opacity.

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

Three cornea's

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

2.457

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Negative Control: Distilled water

The corneas treated with distilled water exhibited IVIS score of 0.576 hence classified as “No Category”.

Positive Control: Acetone

The corneas treated with Acetone exhibited IVIS score of 107.184 hence classified under “Category 1”.

Test Item: Clovanyl-3-Formate (CARYOLAN)

The corneas treated with Clovanyl-3-Formate (CARYOLAN) exhibited IVIS score of 2.457 hence classified under “No Category”.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate [Common name - Clovanyl-3-Formate (CARYOLAN)] along with a negative and a positive control compounds were tested for their irritancy score using bovine corneas as test system (3 corneas per compound) using Opacitometer and Microplate reader to measure opacity density and permeability respectively.
In this study, the negative control (Distilled water) & positive control (Acetone) exhibited expected response as No category (IVIS score 0.576) & Category I (IVIS score 107.184) respectively. The test item Clovanyl-3-Formate (CARYOLAN) exhibited a IVIS score of 2.457.
From the results, it can be concluded that the test item Clovanyl-3-Formate (CARYOLAN) is not an occular irritant and does not cause any eye irritation or serious eye damage.

Executive summary:

The test item Decahydro-1,1,7-trimethyl-3a,7-methano-3aH-cyclopentacyclooct-3-yl formate [Common name - Clovanyl-3-Formate (CARYOLAN)] along with a negative and a positive control compounds were tested for their irritancy score using bovine corneas as test system (3 corneas per compound) using Opacitometer and Microplate reader to measure opacity density and permeability respectively.

In this study, the negative control (Distilled water) & positive control (Acetone) exhibited expected response as No category (IVIS score 0.576) & Category I (IVIS score 107.184) respectively. The test item Clovanyl-3-Formate (CARYOLAN) exhibited a IVIS score of 2.457.  

From the results, it can be concluded that the test item Clovanyl-3-Formate (CARYOLAN) is not an occular irritant and does not cause any eye irritation or serious eye damage.