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EC number: 282-490-8 | CAS number: 84238-29-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Vetiveria zizanioides, Gramineae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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).
Reference
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
- 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).
Reference
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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