2,4,6-trimethylcyclohex-3-enecarbaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 27 November 1984 and 18 January 1985.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

(US) Modified Federal Hazardous Substances Labelling Act Method. (1985)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

The method is similar to and is based upon that prescribedfor the purposes of the United States Federal Hasardous Substances Labelling Act.

Deviations:

yes

Remarks:

Number of animals below the recommended level according to guideline OECD 405 Administrated volume below the recommended level according to guideline OECD 405

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Isocyclocitral PM896

IUPAC Name:

Isocyclocitral PM896

Test material form:

other: liquid

Details on test material:

- Name of test material: Isocyclocitral PM896
- Physical state: Clear colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

other: Tween 80 for 50% dilution

Controls:

no

Amount / concentration applied:

50% and 100%

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 animals

Details on study design:

Test substances are applied to one eye each of three rabbits by gently pulling the lower lid away from the eyeball and placing 10 µL (at 50% in Tween 80) - Group A and 10µL at 100% - Group B in the sac so formed. Eyes are examined 24 hours after treatment and thereafter at daily intervals and graded for corneal, conjunctival and iridial damage.

Eyes are examined before application of the materials and with the aid of a hand-held torch (slit lamp). Conjunctival responses are assessed 15 minutes after treatment. Corneal, conjunctival and iridial responses are assessed 1, 2, 3, 4, 7, 9, 11, 14, 16, 18 & 21 days after treatment except that which falls outside the normal working week (Mon-Fri) are omitted. Assessments are stopped earlier if the eye has returned to normal.

Modification of standard method
Area of cornea and iris affected was assessed as well as intensity.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

not determinable

Remarks:

animal sustained an injury shortly after treatment and was necessarily killed. Concentration tested 50% in Tween 80

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 22 days

Remarks on result:

positive indication of irritation

Remarks:

Concentration tested 50% in Tween 80

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: days 7,8,10,11,14,18, 22

Score:

0.5

Max. score:

4

Reversibility:

not fully reversible within: 22 days

Remarks on result:

positive indication of irritation

Remarks:

Concentration tested 50% in Tween 80

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 22 days

Remarks on result:

positive indication of irritation

Remarks:

Concentration tested 50% in Tween 80

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 7 days

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Remarks on result:

positive indication of irritation

Remarks:

Concentration tested 50% in Tween 80

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 8

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Concentration tested 100% , quantity 0.005mL. Disconfort immediatly after treatment

Results 8

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

not determinable

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: day 7

Remarks on result:

not determinable

Remarks:

Concentration tested 100%

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: day 3

Remarks on result:

positive indication of irritation

Remarks:

Concentration tested 100%

Irritant / corrosive response data:

Group A: Both rabbits showed signs of discomfort on treatment. One animal sustained an injury shortly after treatment and was necessarily killed. The remaining eye showed total loss of the corneal epithelium, with corneal swelling and iritis. Conjuctivitis was moderate, with discharge. The eye developed a persistent pannus.
Group B: One rabbit only was treated. 5µL caused acute discomfort and no further material was instilled in the eye. Subsequently the eye showed only superficial corneal effects with slight conjunctivitis, healing by day 7.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The undiluted material causes intense pain on entering the eye, but subsequently produces only slight transient damage. A 50% dilution produces a reduced pain reaction but causes moderate effects with pannus. Owing to the acute pain produced by this product, no further testing at 100µL dosage was carried out.

Executive summary:

The test substance was assessed for eye irritation using an in vivo method. The undiluted test substance, as supplied, caused intense pain on entering the eye, but subsequently produces only slight transient damage. A 50% dilution produces a reduced pain reaction but causes moderate effects with pannus.