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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods similar to OECD guideline 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

7 day observation period

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

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 E.I.
- Physical state: Liquid
- Lot/batch No.: Confidential
- Other: Test material received from RIFM on January 21, 1972

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.9 - 2.3 kg

ENVIRONMENTAL CONDITIONS
No information available

IN-LIFE DATES: No information available

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: abdominal area (skin was abraded)
- Type of wrap if used: binders of rubber dam, gauze and adhesive tape

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

VEHICLE
No information available

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 rabbits

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and skin irritation

Statistics:

not relevant

Results and discussion

Preliminary study:

not relevant

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Mortality was observed in 1 animal

Mortality:

1/10

Clinical signs:

other: No effects observed

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

Skin irritation: Moderate erythema was noted in 7/10 animals, moderate signs of edema in 9/10 and moderate atonia in 2/10 animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dermal application of Lemongrass oil in 10 New Zealand White rabbits at a dose of 2000 mg/kg body weight resulted in 1 death animal. Therefore, the LD50 was established exceeding 2000 mg/kg and Lemongrass oil does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP), under the conditions of this study.

Executive summary:

A single dose of 2000 mg/kg Lemongrass oil was applied dermally to the abraded abdominal skin of 10 New Zealand White rabbits. The treated skin site was covered with binders of rubber dam, gauze and adhesive tape for 24 hours. After 24 hours, the wrapping was removed and the rabbits were observed for mortality and toxicity for a period of 7 days.

Under the conditions of this study, dermal application of Lemongrass oil caused a mortality of 1/10 in New Zealand White rabbits at a dose of 2000 mg/kg body weight. Signs of skin irritation were observed as moderate erythema in 7/10 animals, moderate signs of edema in 9/10 and moderate atonia in 2/10 animals. In conclusion, the LD50 was established to be exceeding 2000 mg/kg and Lemongrass oil does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP), under the conditions of this study.