p-menth-1-en-8-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Studies on the contact dermatitic properties of pakistani medicinal plants. Part VI. Dermal irritating properties of Lavandula stoechas L

Author:

Saeed M A

Year:

1994

Bibliographic source:

J.Pharm. Univ.Mar., 10 (1), 39 - 49

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: open mouse ear assay. The pilot and main irritancy assay on mice ears were adopted from Evans and Schmidt (1979).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

p-menth-1-en-8-ol

EC Number:

202-680-6

EC Name:

p-menth-1-en-8-ol

Cas Number:

98-55-5

Molecular formula:

C10H18O

IUPAC Name:

2-(4-methylcyclohex-3-en-1-yl)propan-2-ol

Test animals

Species:

mouse

Strain:

other: albino

Details on test animals or test system and environmental conditions:

None

Test system

Type of coverage:

open

Preparation of test site:

other: intact skin (inner surface of animal’s ear)

Vehicle:

other: (acetone)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 µg
- Concentration (if solution): 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 µg/5 µL.

Observation period:

The ears were examined for redness after 30 minutes and then 15 minute interval until two observations indicated that further redness would not occur.

Number of animals:

12 per dose

Details on study design:

TEST SITE
- Area of exposure: inner surface of animal's ear

OBSERVATION TIME POINTS : The ears were examined for redness after 30 minutes and then 15 minute interval until two observations indicated that further redness would not occur.

SCORING SYSTEM:
- Method of calculation:
The time of maximum erythema was noted. The number of ears eliciting the degree of redness corresponding to at least ++ intensity on Hecker's scale at peak irritancy (Hecker 1971) also mentioned by Evans and Schmidt (1979) were noted and expressed in μg / 5 μI per ear.
The chronic effects of the test compound on the animals skin were also recorded after one and two days to ascertain the chronic inflammatory dose. Animals with at least ++ intensity after 24 and 48 hours were recorded and denoted by IU (Irritant units) (Hecker 1971).
The total number of red ears per dilution was tabulated. ID50 (Irritant dose in 50% individuals ) along with the upper and lower confidence limits were calculated by probit analysis.

Results and discussion

In vivo

Results

Irritation parameter:

other: ID50 (μg / 5 μL)

Basis:

mean

Time point:

24/48 h

Score:

0.853

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Alpha terpineol was found irritant with ID50 (Irritant dose in 50% individuals) = 0.853 µg/5 µL. Its reaction lasted for 24 h, indicating IU = 0.625 µg/5 µL after 24 h. No effects were recorded after 48 h up to the highest dose tested (IU>5 µg/5 µL).

Any other information on results incl. tables

Table 1: irritant responses of the compounds Isolated from Lavandula stoechas oil on Albino Mice

Dose levels (μg / 5 μL)		Alpha terpineol
5		11/12
2.5		9/12
1.25		7/12
0.625		5/12
0.3125		3/12
0.15625		1/12
ID 50	μg / 5 μL	0.853
	S.D	0.128
	t	3.25
	U.C.L.	1.369
	L.C.L.	0.552
IU (μg / 5μL) after	24 h	0.625
	48 h	>5

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the test conditions, alpha terpineol was found to be a skin irritant.

Executive summary:

The irritant potentials of Lavandula stoechas were investigated on albino mice. Six of its components were evaluated for irritancy by open mouse ear assay. Alpha terpineol was dissolved in acetone (10 mg/10 mL (w /v) solution). Further dilutions were prepared. Doses of 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 µg/5 µL were applied to inner surface of animal’s ear. The ears were examined for redness after 30 minutes and then 15 minute interval until two observations indicated that further redness would not occur. The time of maximum erythema was noted. The number of ears eliciting the degree of redness according to Hecker's scale were noted and expressed in μg / 5 μI per ear. The chronic effects after 24 and 48 hours were recorded and denoted by IU (Irritant units). ID50 (Irritant dose in 50% individuals ) were calculated by probit analysis. ID50 of alpha terpineol was found to be 0.853 µg/5 µL and its reaction lasted for 24 h, indicating IU = 0.625 µg/5 µL after 24 h. It is concluded that alpha terpineol is a skin irritant.