Essential oil obtained from the leaves of Cymbopogon flexuosus, gramineae by distillation

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test performed smiliar to OECD 404 (Draize test), not according to GLP guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Draize skin test: 24 hours instead of 4 hours exposure, observations at 0 and 72 hours (not at 24 and 48 hours), partly abraded skin, 6 animals used

GLP compliance:

no

Remarks:

Pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Lemongrass oil

IUPAC Name:

Lemongrass oil

Details on test material:

- Name of test material (as cited in study report): Lemongrass
- Substance type: Fragrance material
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 - 3.4 kg
- Housing: animals were individually housed
- Diet (e.g. ad libitum): ad libitum, commercial diets
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped (one flank) and abraded (alternate flank)

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration: No data

VEHICLE
No data available

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Back of the rabbit (abraded and non-abraded)
- % coverage: No data
- Type of wrap if used: Two single layers of gauze (approx. 1 square inch) with adhesive tape and wrapped in nonabsorbent binder.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: Immediately

SCORING SYSTEM: in accordance with the Draize method. Effects were scored immediately after removal of the patch and again after 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: subtotal

Time point:

other: 24 and 72h after application

Score:

9.5

Reversibility:

no data

Remarks on result:

other: Scoring system according to Draize (no details available)

Results 2

Irritation parameter:

edema score

Basis:

other: subtotal

Time point:

other: 24 and 72h after application

Score:

3

Reversibility:

no data

Remarks on result:

other: Scoring system according to Draize (no details available)

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72h after application

Score:

3.1

Max. score:

4

Reversibility:

no data

Irritant / corrosive response data:

No data available.

Other effects:

No data available.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Under the conditions of this test, a subtotal erythema score of 9.5 and a subtotal edema score of 3.0 was determined for Lemongrass oil. The primary dermal irritation index was established to be 3.1 (maximum of 4). As insufficient details are available on the scoring of the skin reactions, no conclusion with respect to EU classification could be drawn. The substance was considered to be moderately irritating.

Executive summary:

In this study the potential of Lemongrass oil with respect to skin irritation was assessed in a Draize test performed in six rabbits (similar to OECD guideline 404). The test substance was applied to both flanks, one with skin abraded and one with intact skin, of each rabbit. The treated areas were immediately covered with gauze which stayed on for 24 hours. 24 and 72 hours after test substance application the treated skin sites were scored for erythema and oedema by using the Draize scoring system. No details were available on the scoring of the skin reactions.

Under the conditions of this test, a subtotal erythema score of 9.5 and a subtotal edema score of 3.0 was determined for Lemongrass oil. The primary dermal irritation index was established to be 3.1 (maximum of 4). As insufficient details are available on the scoring of the skin reactions, no conclusion with respect to EU classification could be drawn. The substance was considered to be moderately irritating.