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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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Multiple studies on the skin sensitising potential of Vetiver Oil were available for the dossier. Because of the comparable reliability between the studies and differing outcomes, a Weight of Evidence approach was used to describe the endpoint of skin sensitisation.
A Buehler test was conducted with Vetivert Oil Haïti and showed clear sensitisation in approximately half of the guinea pigs over the observation period. Two out of three guinea pig maximisation tests indicated skin sensitisation. One test challenged two times with Vetyver Oil Haïti and additionally cross-challenged with Vetyver Oil Blend Java, while the other was performed in the same way although the test substances were switched. In both cases, also the cross-challenge indicated sensitisation. One last guinea pig maximisation test was available, performed with Vetyvert Bourbon, which did not indicate a clear sensitising potential. All above mentioned animal studies were considered highly reliable, although the Buehler test (Klimisch 1) was assigned a higher Klimisch rating over the GPMT's (Klimisch 2) due to the relatively concise and unclear report of the maximisation tests.
Additionally, three human repeated insult patch tests were available of which only one indicated some sensitising potential of Vetiver Oil. These studies were not included in the dossier, for the reason that they were considered less reliable (Klimisch 4) and therefore not valuable enough to influence the conclusion on the classification for the endpoint skin sensitisation.
Based on the above information, it was concluded that Vetiver Oil is a substance that possesses the ability to induce sensitisation. Three out of 4 available animal studies indicated sensitisation, especially the Buehler test, which is the least sensitive test (as it is non-invasive) available for this endpoint.
Migrated from Short description of key information:
Skin sensitisation:
- Buehler test (2.5% Vetivert Oil Haïti): sensitising (method similar to OECD 406)
- GPMT (100% and 5% Vetyver Oil Haïti): sensitising (method similar to OECD 406)
- GPMT (5% Vetyver Oil Blend Java): sensitising (method similar to OECD 406)
- GPMT (2.5% Vetyver Bourbon): not sensitising (method similar to OECD 406)
Justification for selection of skin sensitisation endpoint:
Four studies were available and used in a Weight of Evidence approach
Justification for classification or non-classification
Based on the available data and the Weight of Evidence approach, Vetiver Oil needs to be classified as sensitising when taking into account the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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