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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and 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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(Paris, 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

Test material form:

other: Liquid

Details on test material:

(-)-α-Bisabolol

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Animal Breeder: gaukler; D-6050 Offenfach/ Main, FRG
- Weight at study initiation: male 2.84 kg, females 3.0 kg
- Housing: Singly housing in stainless steel cages with wire mesh walk floors (floor area: 40 x 51 cm).
- Diet: Kilba 341, 4 MM (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland); about 130 g/animal/day
- Water (e.g. ad libitum): tap water; about 250 mL/animal/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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

no vehicle

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

Application of 0.5 mL of the undiluted test substance to test patches (2.5 x 2.5 cm).

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Details on study design:

Clipping of the fur: at least 15 hours before study start
Test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)
Application site: upper third of the back or flanks
Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1:1).
Readings: 30 - 60 minutes after removal of the test patch and 24 h, 48 h, 72 h and 7 d after beginning of application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48h, 72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: only one animal showed a slight edema after 24 h

Any other information on results incl. tables

Readings	Animal	Erythema	Edema	Further findings
4h	1	1	0
	2	1	0
	3	1	0
24h	1	2	0
	2	1	0
	3	2	1
48h	1	1	0
	2	0	0
	3	2	0
72h	1	0	0	scaling
	2	0	0
	3	1	0	scaling
7d	1	0	0	scaling
	2	0	0	scaling
	3	0	0	scaling
Mean (24h-72h)	1	1,0	0,0
	2	0,3	0,0
	3	1,7	0,3
Mean (24h-72h)	all animals	1,0	0,1