3,7-dimethyloct-6-en-1-yn-3-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978, other details not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: pre-GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No. 187, 5 .1500.42, S. 27019 dated 27.09.73

Principles of method if other than guideline:

Assessment according to Draize

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethyloct-6-en-1-yn-3-ol

EC Number:

249-482-6

EC Name:

3,7-dimethyloct-6-en-1-yn-3-ol

Cas Number:

29171-20-8

Molecular formula:

C10H16O

IUPAC Name:

3,7-dimethyloct-6-en-1-yn-3-ol

Constituent 2

Reference substance name:

29717-20-8

IUPAC Name:

29717-20-8

Details on test material:

- Name of test material (as cited in study report): Dehydrolinalool
- Physical state: liquid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: non treated eye

Amount / concentration applied:

not known

Observation period (in vivo):

Observations of the eyes were made 24, 48, 72 h, and 8 days later.

Number of animals or in vitro replicates:

6

Details on study design:

The test substance (amount not indicated) was instilled into the conjunctival say of one eye of six rabbits. Observations of the eyes were made 24, 48, 72 h, and 8 days later. Parameters evaluated were corneal opacity and area involved, iris as well as conjunctiva redness, chemosis, and secretion. Scoring of the eyes was done as follows: For cornea and conjunctiva chemosis grade 1 ¿ mild, grade 2 - marked, grade 3 ¿ strong and grade 4 ¿ very strong were used. For conjunctiva redness and secretion grade 1 - mild, grade 2 - marked, and grade 3 - strong were used. For iris grade 1 ¿ ciliary injection, and grade 2 ¿ iritis were used.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 8 d

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 8 d

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 8 d

Results 10

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 8 d

Results 11

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 d

Results 12

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 18

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 19

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 8 d

Results 20

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 8 d

Results 21

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 22

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 8 d

Results 23

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 8 d

Results 24

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Results 25

Irritation parameter:

other: secretion

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 26

Irritation parameter:

other: secretion

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 27

Irritation parameter:

other: secretion

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Results 28

Irritation parameter:

other: secretion

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 29

Irritation parameter:

other: secretion

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Results 30

Irritation parameter:

other: secretion

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 8 d

Irritant / corrosive response data:

Corneal opacity grade 1 was noted in all 6 animals at the 24, 48 h reading getting to grade 2 corneal opacity in 4 out of 6 animals after 72 h. After 8 days grade 1 (3 animals) and grade 2 (3 animals) were noted. The involved area was more than 75% of the cornea. Ciliary injection was noted in 3 of 6, 5 of 6, 5 of 6 and 1 of 6 animals after 24, 48, 72h, and 8 days, respectively. Conjunctiva scores were noted in 2 of 6 (24h reading), 5 of 6 (48 and 72 h reading) and 4 of 6 animals (8 days reading). Grade 1-2 conjunctiva redness was seen in all animals up to day 8, grade 2 chemosis was seen after 24h with tendency to regression in all animals. After 8 days, grade 1 chemosis was seen only in 2 animals. Grade 1 secretion was noted in 5 of 6 animals with 1 animal showing grade 3 secretion at 24, 48, and 72 h. After 8 days, all animals showed grade 1 secretion.

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	24h	48h	72h	8 days	Mean (24-72 hours)
Corneal	1	1 (4)	1 (4)	2 (4)	1 (4)	1.3
opacity	2	1 (4)	1 (4)	2 (4)	1 (4)	1.3
	3	1 (4)	2 (4)	2 (4)	2 (4)	1.7
	4	1 (4)	1 (4)	1 (4)	2 (4)	1.0
	5	1 (4) Pv	1 (4) Pv	1 (4) Pv	1 (4)	1.0
	6	1 (4)	1 (4)	2 (4)	2 (4) Pv	1.3
Iris	1	0	0	1	0	0.3
	2	1	1	0	0	0.7
	3	0	1	1	0	0.7
	4	0	1	1	0	0.7
	5	1	1	1	0	1.0
	6	1	1	1	1	1.0
Conjunctiva
redness	1	1	1	1	1	1.0
	2	2	2 Na	2 Na	1	2.0
	3	2 Na	2 Na	2 Na	2 Na	2.0
	4	2	2 Na	2 Na	1 Na	2.0
	5	2 Na	2 Na	2 Na	1 Na	2.0
	6	2	2 Na	2 Na	2 Na	2.0
chemosis	1	2	0	0	0	0.7
	2	2	2	1	0	1.7
	3	2	2	2	1	2.0
	4	2	2	1	0	1.7
	5	2	1	1	0	1.3
	6	2	1	1	1	1.3
secretion	1	1	1	1	1	1.0
	2	1	1	1	1	1.0
	3	3	3	3	1	3.0
	4	1	1	1	1	1.0
	5	1	1	1	1	1.0
	6	1	1	1	1	1.0

*          values in brackets indicate area involved (4 = > ¾)
Pv       pupil constricted
Na       Scar

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the criteria laid down in Regulation 1272/2008/EC, the test item is considered an eye irritant (category 2).

Executive summary:

Based on the criteria laid down in Regulation 1272/2008/EC, the test item is considered an eye irritant (category 2).