Vetiveria zizanioides, ext.

Endpoint summary

Description of key information

Acute oral toxicity (equivalent to OECD 401, pre-GLP)): LD50>5000 mg/kg bw (limit test)
Acute dermal toxicity (equivalent to OECD 402, pre-GLP): LD50>5000 mg/kg bw (limit test)

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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods resembling OECD guideline 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and a table with results is included.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

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 g
- Fasting period before study:
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Fasting period: 18 hrs

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 rats (male)

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.

Mortality:

No mortality observed

Clinical signs:

other: No effects observed

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 oral LD50 value of vetivert oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).

Executive summary:

A single 5000 mg/kg bw dose of vetiver t oil was administered by oral gavage to 10 male Wistar albino rats. The animals were observed for 14 days while food and water were available ad libitum. No mortality and no symptoms were noted. The oral LD50 value of vetivert oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 µg/kg bw

Quality of whole database:

Test was conducted according to methods resembling OECD guideline 402 (limit test) and was performed pre-GLP. The results therefore were deemed reliable for this endpoint.

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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods resembling OECD guideline 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and a table with results is included.

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

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: 1.7-2.7 kg

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: Adbominal area
- Type of wrap if used: 2 single layers of gauze and impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours

Duration of exposure:

No data

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 rabbits, unspecified sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and skin irritation

Statistics:

Not relevant

Preliminary study:

Not relevant

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Moderate redness and oedema of skin was noted in 10 out of 10 animals

Mortality:

No mortality observed.

Clinical signs:

other: No effects observed.

Gross pathology:

Not performed.

Other findings:

- Other observations: moderate redness and edema was noted in 10 out of 10 animals (skin irritation)

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, dermal application of Vetiver Bourbon did not induce any mortality at a dose of 5000 mg/kg. Therefore, a LD50 of >5000 mg/kg was established and the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).

Executive summary:

A single dose of 5000 mg/kg test material was applied dermally to the abraded abdominal skin of 10 New Zealand White rabbits. Skin was covered with 2 single layers of gauze and wrapped with impervious material for 24 hours. After 24 hours the wrapping was removed and the rabbits were cleansed. The rabbits were observed for 14 days thereafter for mortality and symptomatology (skin irritation).

Under the conditions of this study, dermal application of Vetiver Bourbon did not induce any mortality or clinical signs at a dose of 5000 mg/kg. Skin irritation was observed, as moderate redness and oedema was recorded in 10 out of 10 test animals. In conclusion, a LD50 of >5000 mg/kg was established and the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Test was conducted according to methods resembling OECD guideline 402 (limit test) and was performed pre-GLP. The results therefore were deemed reliable for this endpoint.

Additional information

Oral

In an acute oral toxicity study which was performed according to a method resembling OECD 401 (pre-GLP), a single 5000 mg/kg bw dose of vetiver oil was administered by oral gavage to 10 male Wistar albino rats. The animals were observed for 14 days while food and water were available ad libitum. No mortality and no symptoms were noted. The oral LD50 value of vetivert oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Dermal

In an acute dermal toxicity study which was performed according to a method resembling OECD 402 (pre-GLP), a single dose of 5000 mg/kg test material was applied dermally to the abraded abdominal skin of 10 New Zealand White rabbits. Skin was covered with 2 single layers of gauze and wrapped with impervious material for 24 hours. After 24 hours the wrapping was removed and the rabbits were cleansed. The rabbits were observed for 14 days thereafter for mortality and symptomatology (skin irritation). Under the conditions of this study, dermal application of Vetiver Bourbon did not induce any mortality or clinical signs at a dose of 5000 mg/kg. Skin irritation was observed, as moderate redness and oedema was recorded in 10 out of 10 test animals. In conclusion, a LD50 of >5000 mg/kg was established.

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

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

Justification for classification or non-classification

Based on the available information, Vetiver oil does not have to be classified as acute toxic via the oral and dermal route, in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP) and Annex VI of 67/548/EEC (DSD).