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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 401 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 401 (Acute Oral Toxicity)

Deviations:

no

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. (71-4-48)
- Substance type: Fragrance material
- Physical state: Liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 250
- Fasting period before study: 16-18 hours
- Diet (e.g. ad libitum): ad libitum (after dosing)
- Water (e.g. ad libitum): ad libitum (after dosing

ENVIRONMENTAL CONDITIONS
No information available

IN-LIFE DATES: No information available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No data available

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 male rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (and frequently on day of test)
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology

Statistics:

not relevant

Results and discussion

Preliminary study:

not relevant

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 3/10 animals died

Mortality:

3/10

Clinical signs:

other: Lethargy, slow respiration and ptosis

Gross pathology:

Not performed

Other findings:

Necropsy was not performed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 value of Lemongrass oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. Lemongrass oil therefore does not need to be classified according to the criteria outlined in Annex I of 1272/2008/EC (CLP).

Executive summary:

A single dose of lemongrass oil (5000 mg/kg bw) was administered by oral gavage to 10 male albino Wistar rats. The animals were observed for 14 days while food and water were available ad libitum.

Three out of 10 animals died within 48 hours. The following clinical signs were observed: lethargy, slow respiration and ptosis. The oral LD50 value of Lemongrass oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Lemongrass oil therefore does not have to be classifiied according to the criteria outlined in Annex I of 1272/2008/EC (CLP).