Levomenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 October 1988 - 02 March 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

Deviations:

no

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:

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

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: Idividually 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 (dark / light): 12 h / 12 h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

72 hours (substance was 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:

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was not washed out.

SCORING SYSTEM: According to OECD guideline OECD 405
- Readings: 1 h, 24 h, 48 h, 72 h after application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 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:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Table 1: Results

		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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions chosen, the test substance is considered not to be irritating to the eye.

Executive summary:

A study according to OECD guideline 405 was designed to assess the eye irritation potential of the test item. 0.1 mL of test substance were applied undiluted to the conjunctival sac of the right eyelid of 3 rabbits. The untreated eyes of the same animals served as control. The substance was not washed out and the reaction to the eyes was observed 1, 24, 48 and 72 hours after application. Mean erythrema, edama and chemosis scores at 24/48/72 h were 0.0 and the mean conjunctivae score was 1.2. This observed effect was reversible within 72 hours. The test substance is considered not to be irritating to the eye.