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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
Vetiver bourbon
IUPAC Name:
Vetiver bourbon
Details on test material:
- Name of test material (as cited in study report): Vetiver bourbon
- Physical state: liquid
- Purity: no data
- Lot/batch No.: confidential

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

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 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

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.
Mortality:
No mortality observed
Clinical signs:
No effects observed
Body weight:
No data available
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 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).