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Administrative data

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:
No effects observed
Body weight:
No data available
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:
No effects observed.
Body weight:
No data on weight change reported.
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).

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