Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 April 1983 to 27 April 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

EC Number:

915-335-6

Molecular formula:

C11H20O2 C10H20O

IUPAC Name:

Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2-3 kg
- Housing: housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne Rabbit Ration, checked daily and added or replaced, ad libitum
- Water: tap water, in 16 ounce glass bottles with sipper tubes or an automatic watering system, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 April 1983, To: 27 April 1983

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of each rabbit served as control

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

METHOD
- Twenty-four hours prior to the application of the test material, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing pre-existing corneal injury were eliminated from the study. The test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball (conjunctival cul-de-sac) to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of the test material. The contralateral eye remained untreated and served as a control.
- The eyes were examined at 1, 24, 48 and 72 hours and 7 days after treatment. The grades of ocular reaction (Table 1) were recorded at each examination. Grading of irritation is according to the method of Draize.
- An animal exhibited a positive reaction when the test substance produced one or more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), or an obvious swelling in the conjunctivae (excluding the cornea and iris) with a partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1 and 4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 2, 3, 5, and 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

animal: 1, 3, and 5

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

iris score

Basis:

animal: 2, 4, and 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: 1 and 3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: 2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: 4

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal: 5

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal: 6

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal: 1 and 4

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal: 2 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal: 3 and 5

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Individual animal irritation scoring data can be found in table 2. Positive ocular responses were recorded at the 1, 24, 48 and 72 hour observation periods. No positive ocular responses were recorded on Day 7 at which time the study was terminated.

Any other information on results incl. tables

Table 2: The primary eye irritation data for individual animals and observation times is summarized in the following table.

Rabbit		Cornea			Iris		Conjunctivae				Total
Number	Hr/Day	A (Opacity)	B (Area)	(A x B x 5)	A	A X 5	A (Redness)	B (Chemosis)	C (Discharge)	(A + B + C) x 2	Score
3118	1 hours	0	0	0	1	5	2	2	1	10	15
male	24 hours	1	4	20	1	5	2	2	3	14	39
	48 hours	1	4	20	0	0	1	1	0	4	24
	72 hours	1	4	20	0	0	0	1	1	4	24
	day 7	0	0	0	0	0	0	0	0	0	0
	Mean=	0.60	2.40		0.40		1.00	1.20	1.00
Mean	(24,48 and 72 hr)	1.00	4.00		0.33		1.00	1.33	1.33
3119	1 hours	0	0	0	0	0	2	1	1	8	8
male	24 hours	0	0	0	0	0	0	0	1	2	2
	48 hours	0	0	0	0	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0	0	0	0	0
	day 7	0	0	0	0	0	0	0	0	0	0
	Mean=	0.00	0.00		0.00		0.40	0.20	0.40
Mean	(24,48 and 72 hr)	0.00	0.00		0.00		0.00	0.00	0.33
3120	1 hours	0	0	0	0	0	1	0	1	4	4
male	24 hours	0	0	0	1	5	2	1	1	8	13
	48 hours	0	0	0	0	0	1	0	0	2	2
	72 hours	0	0	0	0	0	0	0	0	0	0
	day 7	0	0	0	0	0	0	0	0	0	0
	Mean=	0.00	0.00		0.20		0.80	0.20	0.40
Mean	(24,48 and 72 hr)	0.00	0.00		0.33		1.00	0.33	0.33
3121	1 hours	0	0	0	1	5	2	2	2	12	17
female	24 hours	1	4	20	0	0	3	2	1	12	32
	48 hours	1	4	20	0	0	2	1	1	8	28
	72 hours	1	4	20	0	0	1	1	1	6	26
	day 7	0	0	0	0	0	0	0	0	0	0
	Mean=	0.6	2.4		0.2		1.6	1.2	1
Mean	(24,48 and 72 hr)	1.00	4.00		0.00		2.00	1.33	1.00
3122	1 hours	0	0	0	1	5	1	1	1	6	11
female	24 hours	0	0	0	1	5	2	1	1	8	13
	48 hours	0	0	0	0	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0	0	0	0	0
	day 7	0	0	0	0	0	0	0	0	0	0
	Mean=	0.00	0.00		0.40		0.60	0.40	0.40
Mean	(24,48 and 72 hr)	0.00	0.00		0.33		0.67	0.33	0.33
3123	1 hours	0	0	0	0	0	1	0	1	4	4
female	24 hours	0	0	0	0	0	1	0	0	2	2
	48 hours	0	0	0	0	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0	0	0	0	0
	day 7	0	0	0	0	0	0	0	0	0	0
	Mean=	0.00	0.00		0.00		0.40	0.00	0.20
Mean	(24,48 and 72 hr)	0.00	0.00		0.00		0.33	0.00	0.00
Mean by sample time =
	1 hours	0.00	0.00		0.50		1.50	1.00	1.17		9.83
	24 hours	0.33	1.33		0.50		1.67	1.00	1.17		16.83
	48 hours	0.33	1.33		0.00		0.67	0.33	0.17		9.00
	72 hours	0.33	1.33		0.00		0.17	0.33	0.33		8.33
	day 7	0.00	0.00		0.00		0.00	0.00	0.00		0.00

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant

Remarks:

according to EU CLP (EC 1272/2008 and its amendments)

Conclusions:

An in vivo eye irritation test was conducted similar to OECD 405 and following GLP principles.

Executive summary:

In an eye irritation study, performed similar to OECD 405 and following GLP principles, 0.1 mL of undiluted test substance was applied to six rabbit eyes followed by examinations at 24-, 48 and 72-hours and at day 7 days following treatment. The following results were obtained and expressed as mean scores 24, 48, and 72 hours after removal of the substance: Corneal opacity (score 1) was observed in 2 out of 6 animals. Iritis (Score 0.33) was observed in 3 out of 6 animals. Conjunctivae redness was observed in 5 out of 6 animals with scoring of 0.33, 0.67, 1 (2 animals), and 2, respectively. Chemosis was observed in 4 out of 6 animals with scoring of 0.33 (2 animals), and 1.33 (2 animals). All effects were cleared with 7 days.