Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Jan 1978 - 15 Feb 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed according to Modified Federal Hazardous Substance labelling Act Method (similar to OECD 405), but not under GLP-conditions.

Justification for type of information:

Results are from an in vivo test conducted before the Reach Regulation came into force requesting in vitro information.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

additionally, the area of cornea and iris affected was measured.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

1

Reference substance name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate

EC Number:

916-331-7

Molecular formula:

C14H20O2

IUPAC Name:

Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Morton Commascidand S Colworth rabbits

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
Age: approximately 8 weeks old.

ENVIRONMENTAL CONDITIONS
No data available.

IN-LIFE DATES: From: 23 January 1978 To: 7 February 1978 (?)

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

Test substance used as supplied.

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

No data available.

Observation period (in vivo):

Assessment of ocular damage was made approximately 15 minutes, 4 hours after exposure and daily thereafter until 11 days and after 15 days. Animals were only assessed at these time points if ocular damage was present at the previous assessment.

Number of animals or in vitro replicates:

In total 13 animals were used: 7 animals were treated (one eye per animal), 6 animals were used as control.

Details on study design:

A drop of local anesthetic (amethocaine hydrochloride) was placed in each eye prior to application of the test substance to prevent discomfort.

REMOVAL OF TEST SUBSTANCE
Not applicable

SCORING SYSTEM:
Scoring system in accordance with Modified Federal Hazardous Substances Labelling Act Method. Additionally, area of affected cornea and iris was assessed.

TOOL USED TO ASSESS SCORE: Slit lamp
Controls: Tween 80 was used as negative control substance

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.93

Max. score:

4

Reversibility:

fully reversible within: 15 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.48

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

0.62

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.62

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Cyclabute, as supplied, caused slight to moderate corneal lesions affecting up to 3/4 of the corneal surface in all the animals. The lesions were associated with slight to severe corneal swelling. Slight to severe conjunctivitis developed in all the animals, iritis developed in four animals and animal had slight discharge. The lesions had healed within 15 days.
Tween 80 (used as control) as supplied, caused slight corneal lesions in two animals, together with slight conjunctivitis in one of the animals. The lesions healed within three days. The remaining four animals were unaffected.

Other effects:

Not applicable

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant

Remarks:

according to EU CLP (EC1272/2008 and its updates)

Conclusions:

Cyclabute was considered not to be irritating to eyes.

Executive summary:

This study report describes the ability of Cyclabute to induce eye irritation in rabbits. The possible eye irritation potential of cyclabute was tested in one eye of each animal, and application was followed by a 15 day observation period. The study procedures described in this report were based on the Federal Hazardous Substance labelling Act Method (similar to OECD 405).

One eye of each rabbit (6 rabbits in total) was treated with a drop of local anesthetic (amethocaine hydrochloride) prior to application of 0.1 mL Cyclabute. Treatment was followed by a 15 day observation period with typical observation points at 15 minutes, 4 hours, and daily thereafter. 6 Other rabbits were treated with Tween-80 in one eye for control purposes. Corneal, conjunctival and iridial damage was scored to determine eye irritation potential.

Cyclabute, as supplied, caused slight to moderate corneal lesions affecting up to 3/4 of the corneal surface in all the animals. The lesions were associated with slight to severe corneal swelling. Slight to severe conjunctivitis developed in all the animals, iritis developed in four animals and one animal had slight discharge. The lesions had healed within 15 days. The negative control substance Tween 80, as supplied, caused slight corneal lesions in two animals, together with slight conjunctivitis in one of the animals. The lesions healed within three days. The remaining four animals were unaffected. The substance is not an eye irritant.