3-Cyclohexene-1-methanol, α,4-dimethyl-α-(4-methyl-3-penten-1-yl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

Test substance represents a main component (stereoisomer) of the registered substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: according to current guidelines, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Levomenol

EC Number:

245-423-3

EC Name:

Levomenol

Cas Number:

23089-26-1

Molecular formula:

C15H26O

IUPAC Name:

(2S)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol

Details on test material:

- Name of the test substance used in the study report: (-)-α-Bisabolol

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Animal Breeder: Gaukler, D-6050 Offenbach/Main, FRG
- Mean weight at study initiation: males 3.59 kg, female 3.57 kg
- Housing: Singly housing in stainless steel cages with wire mesh walk floors (floor area: 40 x 51 cm).
- Diet: about 130 g per animal per day of Kliba 341, 4 MM (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 8 days before study start (same housing conditions as during the study).

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod: 12 h/12 h (6.00 - 18.00 hours/ 18.00 - 6.00 hours)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

Single application of 0.1 mL to the conjunctival sac of the right eyelid.

Duration of treatment / exposure:

72 hours (substance not washed out)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 (two males, one female)

Details on study design:

The test substance was not washed out.
Readings: 1 h, 24 h, 48 h, 72 h after application
SCORING SYSTEM: acc. to guideline OECD 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24 - 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 24 - 72 h

Score:

1.2

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

		Cornea	Iris	Conjunctiva
Readings	Animal	Opacity		Redness	Swelling	Further findings
1h	1	0	0	2	0
	2	0	0	2	0
	3	0	0	2	0
24h	1	0	0	2	0
	2	0	0	2	0
	3	0	0	2	0
48h	1	0	0	1	0
	2	0	0	2	0
	3	0	0	2	0
72h	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
Mean (24h-72h)	1	0,0	0,0	1,0	0,0
	2	0,0	0,0	1,3	0,0
	3	0,0	0,0	1,3	0,0
Mean (24h-72h)	all animals	0,0	0,0	1,2	0,0