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

Endpoint summary

Description of key information

Acute oral toxicity: LD50>5000 mg/kg bw (similar to OECD 401)
Acute dermal toxicity: LD50>2000 mg/kg bw (similar to OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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

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

Preliminary study:

not relevant

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

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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

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

Preliminary study:

not relevant

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

A key study (method equivalent to OECD 401) is available in which a single dose of Lemongrass oil (5000 mg/kg bw) was administered by oral gavage to 10 male albino Wistar rats. Three out of 10 animals died within 48 hours and therefore the oral LD50 value of Lemongrass oil in rats was established to be >5000 mg/kg body weight. Furthermore, two supporting studies (method equivalent to OECD 401) are available that confirm the LD50 value of >5000 mg/kg bw.

Acute dermal toxicity

A key study (method equivalent to OECD 402) is available in which a single dose of 2000 mg/kg Lemongrass oil was applied dermally to the abraded abdominal skin of 10 New Zealand White rabbits. The dermal application of Lemongrass oil caused a mortality 1 one animal and therefore the LD50 was established to be >2000 mg/kg. This result is confirmed by two supporting studies (method equivalent to OECD 402) in which an LD50 of >5000 mg/kg bw was determined (50% of animals had abraded skin).

Justification for selection of acute toxicity – oral endpoint
The selected study is the key study for this endpoint.

Justification for selection of acute toxicity – dermal endpoint
The selected study is the key study for this endpoint.

Justification for classification or non-classification

Based on the available information, Cymbopogon flexuoses (Lemongrass oil) has shown to be non-toxic after oral exposure. Therefore, the substance does not need to be classified for Acute Oral Toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).

Based on the available information, Cymbopogon flexuoses has shown to be non-toxic in contact with skin. Therefore, the substance does not need to be classified for Acute Dermal Toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).