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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 289-632-8 | CAS number: 89958-10-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Bulnesia sarmienti, Zygophyllaceae.
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18-01-2016 to 25-01-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- In accordance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bulnesia sarmienti, ext.
- EC Number:
- 289-632-8
- EC Name:
- Bulnesia sarmienti, ext.
- Cas Number:
- 89958-10-1
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, and structural formula canoot be given.
- IUPAC Name:
- Essential oil of Guaiacwood obtained from the wood of Bulnesia sarmientoi by steam distillation
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Guaiacwood oil
- Physical state: viscous liquid
- Storage condition of test material: at room temperature protected from light
Constituent 1
- Specific details on test material used for the study:
- Guaiacwood oil was heated until approximately 55°C to obtain a homogeneous liquid sample.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Adult donors
- Source strain:
- other: Strains no: 09-KERA-009, 08-KERA-008, 08-KERA-001, 10-KERA-005
- Details on animal used as source of test system:
- Not relevant
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 16-EKIN-003)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.0 ± 1.0°C (actual range 36.2 - 36.7°C), with the exception of the test item incubation for 15 minutes at room temperature
- Temperature of post-treatment incubation (if applicable): 37.0 ± 1.0°C (actual range 36.2 - 36.7°C)
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The tissues were washed with phosphate buffered saline to remove residual test item
- Observable damage in the tissue due to washing: The test item clotted during rinsing and was difficult to remove, however since in the end the tissue was clean and no test item was left this did not affect the results.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/ml
- Incubation time: 3 hours at 37°C
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the relative mean tissue viability of three viability tissues after 15 minutes exposure and 42 hours post incubation is less than or equal to 50% of the mean viability of the negative controls.
- The test substance is considered to be non-irritant to skin if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µL of the test item was applied (undiluted) to each of triplicate tissues
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL PBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 25 µL SDS
- Concentration (if solution): 5% in PBS - Duration of treatment / exposure:
- 15 ± 0.5 min at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 hours at 37°C
- Number of replicates:
- Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean (percentage of control)
- Value:
- 11
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean tissue viability (percentage of control): 17%
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
Guaiacwood oil was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because no colour changes were observed it was concluded that Guaiacwood oil did not interact with the MTT endpoint.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the Standard Deviation value (SD) of the % viability should be ≤18. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range.
- Acceptance criteria met for positive control: The mean relative tissue viability of the positive control should be ≤50% relative to the negative control and the Standard Deviation value (SD) of the % viability should be ≤18. The positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 17%.
- Acceptance criteria met for variability between replicate measurements: The SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18. The standard deviation value of the percentage viability of three tissues treated identically was less than 10%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- No discrimination between irritation and corrosivity possible (additional test needed).
- Conclusions:
- Under the conditions of this test, the relative cell viability values decreased to 11% which is below the threshold for irritancy of ≤50%. Therefore, it can be concluded that the test item Guaiacwood oil is at least an irritant to skin and further research is needed to assign a classification in accordance with 1272/2008/EC (CLP).
- Executive summary:
This in vitro study was performed according to OECD 439 to assess the irritation potential of Guaiacwood oil by means of the Human Skin Model Test (OECD TG 439). Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. Tissue viability was determined for the test item and the positive control (as a percentage of the negative control viability) and mean tissue viability was calculated accordingly.
After treatment with Guaiacwood oil, the mean tissue viability was found to be 11%. This value is below the threshold for irritancy of ≤50%. Based on the results obtained, it can be concluded that Guaiacwood oil is at least an irritant to skin and further research is needed to be able to assign a classification in accordance with 1272/2008/EC (CLP).
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.