Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 14 January 1979 - 27 June 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to methods resembling OECD guideline 406 but pre-GLP. The study report was concise but sufficient for use in a Weight of Evidence approach.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- in negative control: number of control animals
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Vetyvert Bourbon
- IUPAC Name:
- Vetyvert Bourbon
- Details on test material:
- - Name of test material (as cited in study report): Vetyvert Bourbon
- Physical state: Cream
- Lot/batch No.: Confidential information
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal: 0.01% dobs/saline, epicutaneous: ethanol
- Concentration / amount:
- Intradermal induction: 0.5%
Topical induction: 10%
Topical challenge: 2.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal: 0.01% dobs/saline, epicutaneous: ethanol
- Concentration / amount:
- Intradermal induction: 0.5%
Topical induction: 10%
Topical challenge: 2.5%
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: treated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: treated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: treated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: treated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 2.0. Total no. in groups: 9.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 2
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 3rd challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 2.0. Total no. in groups: 9.0.
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 24
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: 3rd challenge. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 3rd challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
- Reading:
- other: 3rd challenge
- Hours after challenge:
- 48
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: 3rd challenge. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: 4th challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 4th challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
- Reading:
- other: 4th challenge
- Hours after challenge:
- 24
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: 4th challenge. . Hours after challenge: 24.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- other: 4th challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: other: 4th challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 1.0. Total no. in groups: 9.0.
- Reading:
- other: 4th challenge
- Hours after challenge:
- 48
- Group:
- other: untreated control group
- Dose level:
- 2.5% Vetyvert Bourbon
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: 4th challenge. . Hours after challenge: 48.0. Group: other: untreated control group. Dose level: 2.5% Vetyvert Bourbon. No with. + reactions: 0.0. Total no. in groups: 4.0.
Any other information on results incl. tables
1 animal of the test group was sacrificed prior to first challenge as it suffered from a broken leg due to being trapped in the cage floor.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, 2.5% Vetyvert Bourbon induced only little and mild skin reactions at all four challenges. A maximum sensitisation rate of 22.2% was calculated for the first readings at the second (rechallenge) and third challenge. The control groups did not show any positive skin reactions. Based on these results the substance does not need to be classified as a sensitiser based on the criteria outline in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
- Executive summary:
This guinea pig maximisation test (GPMT) was performed to study the sensitising potential of Vetyvert Bourbon. The methods used resemble those outlined in OECD 406, except for the control groups used. Both an untreated (no induction, only challenge similar to test group) and treated (induction - without test substance - and challenge similar to test group) control group was included. Test group contained 10 animals, control groups contained 4 (different) animals per challenge. Challenges were performed with 2.5% Vetyvert Bourbon in ethanol.
1 animal was sacrificed prior to first challenge as it suffered from a broken leg due to being trapped in the cage floor. No positive skin reactions were observed in any of the controls at all of the four challenges. At first challenge, no positive skin response were observed in the test group (at both readings). At second (rechallenge) and third challenge, 2 and 1 out of 9 animals showed positive reactions at the 24 hour and 48 hour readings, respectively. At fourth challenge, at both readings 1 out of 9 animals showed a positive skin reaction.
Under the conditions of this study, 2.5% Vetyvert Bourbon induced only little and mild skin reactions at all four challenges. A maximum sensitisation rate of 22.2% was calculated for the first readings at the second (rechallenge) and third challenge. The control groups did not show any positive skin reactions. Based on these results the substance does not need to be classified as a sensitiser based on the criteria outline 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.