L-p-mentha-1(6),8-dien-2-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06-09-1999 to 10-09-1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline No. 405 (Acute Eye Irritation/Corrosion) and EEC Guideline Method B.5

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-p-mentha-1(6),8-dien-2-one

EC Number:

229-352-5

EC Name:

L-p-mentha-1(6),8-dien-2-one

Cas Number:

6485-40-1

Molecular formula:

C10H14O

IUPAC Name:

(5R)-2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one

Test material form:

other: Colourless to slight yellowish, liquid

Details on test material:

- Name of test material (as cited in study report): CARVONE L
- Physical state: Colourless to slight yellowish, liquid
- Analytical purity: 99,4%
- Lot/batch No.: 50458154
- Expiration date of the lot/batch: At least 1 year from receipt (26.08.1999)
- Storage condition of test material: Cool and dry

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand White (SPF albino)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißleg, Germany
- Weight at study initiation: 1.7 - 2.0 kg
- Housing: Caged individually in PPO cages (floor area: 2576 cm2) with perforated floor.
- Diet (e.g. ad libitum): Pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, was available ad libitum
- Water (e.g. ad libitum): Domestic quality drinking water (acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth) ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

1 hr, 24 hr, 48 hr and 72 hr.

Number of animals or in vitro replicates:

4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Method of Draize/Grading of Ocular Lesions in OECD Guideline 405 with additions noted below in Tables 1 and 2.

TOOL USED TO ASSESS SCORE: The eyes were examined and the grade of ocular reaction was recorded 1 hr and 24 hrs later. After the first 24 hr reading, fluorescein was instilled. After rinsing with 20 ml 0.9% sodium chloride solution the eyes were examincd again using UV-light to detect possible
corneal damage.

Only the left eye was treated. The right eye remained untreated and served as control.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

- opacity

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

- redness

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.4

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Individual animal data is presented below (Table 3)

Any other information on results incl. tables

Table 3: Scores for ocular lesions (all animals)

Rabbit No./ Weight per kg		1h	24h	24h	48h	72h	Individual mean score*
				F
1627 / 2.0	Cornea opacity, degree	0	0	0	0	0	0
	Cornea opacity, area	0	0	0	0	0
	Iris	1	0	-	0	0	0
	Conjunctiva:    Redness	2	1	-	0	0	0.33
	Chemosis	1	0	-	0	0	0
	Discharge	0	0	-	0	0
1628 / 1.9	Cornea opacity, degree	0	0	0	0	0	0
	Cornea opacity, area	0	0	0	0	0
	Iris	0	0	-	0	0	0
	Conjunctiva:   Redness	2	1	-	0	0	0.33
	Chemosis	1	0	-	0	0	0
	Discharge	1	0	-	0	0
1629 / 1.7	Cornea opacity, degree	0	0	0	0	0	0
	Cornea opacity, area	0	0	0	0	0
	Iris	0	0	-	0	0	0
	Conjunctiva:   Redness	2	1	-	0	0	0.33
	Chemosis	1	0	-	0	0	0
	Discharge	1	0	-	0	0
1630/ 1.8	Cornea opacity, degree	0	0	0	0	0	0
	Cornea opacity, area	0	0	0	0	0
	Iris	1	0	-	0	0	0
	Conjunctiva:    Redness	2	1	-	1	0	0.67
	Chemosis	1	0	-	0	0	0
	Discharge	0	0	-	0	0

F: Reading after instillation of Fluorescein

* Only the scores from the readings after 24, 48 and 72 hours are included in the calculation of the individual mean scores

Table 4: Summary of mean values from Table 3

	Mean Value
cornea opacity	0
iris lesion	0
redness of conjunctiva	0.4
oedema of conjunctiva (chemosis)	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

The substance L-carvone was not irritating in the eyes of New Zealand White rabbits.

Executive summary:

In a primary eye irritation study (01628) 0.1mL of L-carvone (undiluted) was instilled into the conjunctival sac of the left eye of young adult New Zealand White (SPF albino) rabbits (4/females) for 24 hours. The eye was not washed after instillation of the test article. Animals then were observed for 1 hr, 24 hr, 48 hr and 72 hrs after dosing. Irritation was scored by the method of Draize/Table: Grading of Ocular lesions (OECD 405) with additions noted in Tables 1 and 2.

The following mean values, based on the results from the 24, 48 and 72 hour readings,were calculated - cornea opacity: 0; iris lesion: 0; oedema of conjunctiva (chemosis): 0; redness of conjunctiva: 0.4.

In this study, L-carvone is not an eye irritant based on the results of this OECD guideline/GLP study.