3,7-dimethylnona-1,6-dien-3-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: pre-GLP study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1968

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: In vivo eye irritation according to Draize

Principles of method if other than guideline:

no remarks

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethylnona-1,6-dien-3-ol

EC Number:

233-732-6

EC Name:

3,7-dimethylnona-1,6-dien-3-ol

Cas Number:

10339-55-6

Molecular formula:

C11H20O

IUPAC Name:

3,7-dimethylnona-1,6-dien-3-ol

Details on test material:

Ethyllinalool, no further information

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not available

Test system

Vehicle:

other: unchanged or in diethylphtalate

Controls:

other: The untreated eyes served as controls.

Amount / concentration applied:

The test substance (0.1 mL) was instilled either undiluted or at a 5% concentration in diethylphthalate into the conjunctival sac of one eye of three rabbits.

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

Observations of the eyes were made immediately and 1, 2, 4, 24, 48, and 72 hours later.

Number of animals or in vitro replicates:

3

Details on study design:

Parameters evaluated were corneal opacity, pupil reaction as well as conjunctiva redness, chemosis, and discharge. Reversibility was not tested. Scoring of the eyes was done by the method of Draize: 0-normal, 1-very slight, 2-well defined, 3-moderate, 4-severe.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritant / corrosive response data:

For the undiluted test substance, corneal opacity grade 1 was noted in all 3 animals at the 24, 48, and 72 h readings triggering classification and labeling as an eye irritant. Pupil reaction was present at all readings. Grade 0 to grade 2 conjunctiva redness, chemosis, or discharge were noted (see Table below). The effect is likely to be reversible within 21 days of observation as the effects seen were already declining at the 72 h reading.

Other effects:

no remarks

Any other information on results incl. tables

Eye Irritation: Scores after 24, 48, and 72 h for the undiluted test item

			Time after instillation
	Animal No	1 hour	24 hours	48 hours	72 hours	Mean 24-72 (hours)
Corneal opacity	A	0	1 (4)*	1 (4)*	1 (1)*	1
	B	0	1 (4)*	1 (4)*	1 (1)*	1
	C	0	1 (4)*	1 (4)*	1 (2)*	1
Conjunctiva
redness	A	1	2	2	2	2
	B	1	1	1	2	1.67
	C	1	1	1	1	1
chemosis	A	1	1	1	0	0.67
	B	1	0	0	0	0
	C	1	0	0	0	0
discharge	A	3	2	2	0	1.33
	B	2	1	1	1	1
	C	3	1	2	0	1

*             number in brackets indicates area of cornea involved

The 5% concentration produced no signs of eye irritation at the 24, 48, and 72 h reading time points.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Cat 2 Criteria used for interpretation of results: EU

Conclusions:

Based on the criteria laid down in Regulation 1272/2008/EC, undiluted Ethyllinalool is considered an eye irritant (category 2). A 5% concentration is not irritant to eyes.

Executive summary:

Based on the criteria laid down in Regulation 1272/2008/EC, undiluted Ethyllinalool is considered an eye irritant (category 2). A 5% concentration is not irritant to eyes.