3,7-dimethyloct-1-en-3-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

non-GLP, lack of test article purity information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Adopted in May 12th, 1981

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethyloct-1-en-3-ol

EC Number:

242-358-2

EC Name:

3,7-dimethyloct-1-en-3-ol

Cas Number:

18479-49-7

Molecular formula:

C10H20O

IUPAC Name:

3,7-dimethyloct-1-en-3-ol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

Animals were housed in fully air-conditioned rooms.
Temperature: RANGE OF 20 - 24 DEGREES CELSIUS
Relative humidity: 30 - 70%
Day/night rhythm: 12h/12h
Diet: 250 ml tap water per animal per day, 130g per animal of Kliba 341 4mm Firma Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland
Acclimatization period: at least 8 days before the beginning of the study, same housing conditions as during the study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml (unchanged)

Duration of treatment / exposure:

SINGLE APPLICATION TO THE CONJUNCTIVAL SAC OF THE RIGHT EYELID; THE SUBSTANCE WAS NOT WASHED OUT

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

1

Details on study design:

SINGLE APPLICATION TO THE CONJUNCTIVAL SAC OF THE RIGHT EYELID; THE SUBSTANCE WAS NOT WASHED OUT.
Readings: 1, 24, 48, 72 hours and 8 days

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

not reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

not reversible

Irritant / corrosive response data:

The observation period was 8 days rather than 21 required by the current guideline but this was due to increasingly severe irritation progressing with time.
Following mean grades of ocular lesions were observed: Opacity =1.7 (=3 at Day 8); Iris = 0.7 (=1 at Day 8); Redness = 3.0 (=2 at Day 8); Swelling = 2.7 (=1 at Day 8).

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Executive summary:

The dose (0.1 mL of the undiluted test article) and application of the test substance were adequate. The observation period was 8 days rather than 21 required by the current guideline but this was due to increasingly severe irritation progressing with time. 1 female rabbit was used in theinitial test; a confirmatory test was unnecessary. Readings were performed at 1, 24, 48 and 72 hours and at 8 days after the application.

Although formally the test article can be classified as Category 2 irritant (corneal opacity <3 and iritis <1.5), the symptoms worsened with time (loss of corneal tissue, pannus and suppuration were observed on Day 8) and were not expected to reverse. Therefore, it is classified as Eye Irritant - Category 1.