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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 December 2014
- 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:
- 2 014
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- 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:
- other: waxy solid
- Details on test material:
- - Name of test material (as cited in study report): Guaiacwood oil
- Appearance: Yellow-brown waxy solid
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bovine
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Source: Local abattoir
- Age at study initiation: 12-60 months
From freshly slaughtered animals, eyes were transported to the test facility at day of slaughter and used within 24 hours.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.75 mL
- Concentration: 100% - Duration of treatment / exposure:
- 10 minutes (incubation at 32+/-1 °C)
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- Test substance: 3 corneas
Negative control: 3 corneas
Positive control: 3 corneas - Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed (epithelial side uppermost) in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.
The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (MEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 60 minutes.
QUALITY CHECK OF THE ISOLATED CORNEAS
At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
The medium from both chambers of each holder was replaced with fresh complete MEM. A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer. The average opacity for all corneas was calculated.
NUMBER OF REPLICATES
Three corneas with opacity values close to the median value of all corneas were allocated to the negative control. Three corneas were also allocated to the test item and three corneas to the positive control item.
NEGATIVE CONTROL USED
Identification: 0.9% w/v sodium chloride solution
Batch: 301038501
Purity: 0.9%
Expiry Date: 01 September 2015
Storage Conditions: Room temperature
POSITIVE CONTROL USED
Identification: Ethanol
Batch: STBD7546V
Purity: >99.8%
Expiry Date: 11 August 2015
Storage Conditions: Room temperature
APPLICATION DOSE AND EXPOSURE TIME
The MEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test item or control items were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 10 minutes.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At the end of the exposure period the test item and control items were removed from the anterior
chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM without phenol red. The anterior chamber was refilled with fresh complete MEM without phenol red.
- POST-EXPOSURE INCUBATION: The holders were incubated, anterior chamber facing forward, at 32 ± 1 ºC for 120 minutes.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
Light transmission measured quantitatively with the aid of an opacitometer.
A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer. After exposure and removal of the test substance, a post-treatment opacity reading was taken. After the post-exposure incubation, a final opacity reading was taken.
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting the average change in opacity observed for the negative control corneas.
The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
- Corneal permeability:
Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (4 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 ºC for 90 minutes.
After incubation the medium in the posterior chamber of each holder was decanted and retained. 360 μL of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 492 nm (OD492) was measured using the Anthos 2001 microplate reader.
- Others (e.g, pertinent visual observations, histopathology):
Each cornea was observed visually before treatment, after the exposure and removal of the test substance, and after the post-exposure incubation.
The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labelled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) was calculated as follows:
Mean opacity value + (15*mean OD492 value)
- The change in opacity for each cornea was calculated by subtracting the initial opacity reading from the final opacity reading. This value was corrected by subtracting the average change in opacity for the negative control. The average is used to calculate the IVIS.
- The corrected OD492 was calculated by subtracting the OD492 of the negative control from the OD492 value of each treated cornea. The average is used to calculate the IVIS.
DECISION CRITERIA:
IVIS≤3 = "No category. Not requiring classification to UN GHS or EU CLP",
IVIS >3; ≤55 = "No prediction of eye irritation can be made",
IVIS >55 = "Category 1. UN GHS or EU CLP Causes serious eye damage".
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- IVIS: 2.2
- Positive controls validity:
- valid
- Remarks:
- IVIS: 41.2
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system:
The corneas treated with the test item were clear post treatment and clear post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
The test was acceptable if the negative control produced an In Vitro Irritancy Score which is less than or equal to the upper limit for background opacity and permeability values during 2013 for bovine corneas treated with the respective negative control. When testing liquids the negative control range for opacity should be ≤4.7 and for permeability ≤0.080.
The negative control gave a mean opacity of 1.0 and mean permeability of 0.078. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control:
The test was acceptable if the positive control produced an In Vitro Irritancy Score which fell within two standard deviations of the historical mean collated during 2013 for this testing facility. Therefore the In Vitro Irritancy Score should fall within the range of 27.8 to 51.0.
The positive control In Vitro Irritancy Score was 41.2. The positive control acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea number |
Opacity |
Permeability (OD) |
In Vitro Irritancy Score |
|||||
Pre-Treatment |
Post-Treatment |
Post-Incubation |
Post-Incubation – Pre-Treatment |
Corrected Value |
|
Corrected Value |
|
||
Negative Control |
9 |
1 |
1 |
2 |
1 |
|
0.094 |
|
|
18 |
1 |
1 |
3 |
2 |
|
0.089 |
|
|
|
22 |
1 |
0 |
0 |
0 |
|
0.051 |
|
|
|
|
|
|
|
1.0a |
|
0.078c |
|
2.2 |
|
Positive Control |
1 |
0 |
25 |
29 |
29 |
28.0 |
0.820 |
0.742 |
|
3 |
0 |
23 |
28 |
28 |
27.0 |
0.944 |
0.866 |
|
|
16 |
2 |
28 |
30 |
28 |
27.0 |
1.244 |
1.166 |
|
|
|
|
|
|
|
27.3b |
|
0.925b |
41.2 |
|
Test Item |
17 |
2 |
4 |
4 |
2 |
1.0 |
0.147 |
0.069 |
|
19 |
2 |
2 |
1 |
-1 |
0.0 |
0.052 |
0.000 |
|
|
20 |
0 |
1 |
1 |
1 |
0.0 |
0.040 |
0.000 |
|
|
|
|
|
|
|
0.3b |
|
0.023b |
0.7 |
OD = Optical density
a= Mean of the post-incubation – pre-treatment values
b= Mean corrected value
c= Mean permeability
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the IVIS score for Guaiacwood oil was determined to be 0.7, which is below the limit for classification (IVIS ≤3). Therefore, the test item does not need to be classified in accordance with the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
An in vitro Bovine Corneal Opacity and Permeability (BCOP) Assay was performed with Guaiacwood oil according to OECD guideline 437 and under GLP conditions. Bovine cornea were acquired from a local abattoir, prepared and treated with the test substance, positive control or negative control. In Vitro Irritancy Scores (IVIS) were calculated based on the measured opacity and permeability of the cornea after exposure.
Under the conditions of this study, the IVIS score for Guaiacwood oil was determined to be 0.7, which is below the limit for classification (IVIS ≤3). Therefore, the test item does not need to be classified in accordance with the classification criteria outlined in Annex I of 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.