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EC number: 295-223-5 | CAS number: 91845-48-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Santalum austro-caledonicum, Santalaceae.
- 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:
- 15 February to 09 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 492 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 27 April 2017
Test material
- Reference substance name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- EC Number:
- 204-102-8
- EC Name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- Cas Number:
- 115-71-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 5-(2,3-Dimethyltricyclo[2.2.1.0~2,6~]hept-3-yl)-2-methylpent-2-en-1-ol
- Reference substance name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- EC Number:
- 201-027-2
- EC Name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- Cas Number:
- 77-42-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2-Methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)pent-2-en-1-ol
- Reference substance name:
- (Z)-5-(4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl)-2-methylpent-2-en-1-ol
- Cas Number:
- 88034-74-6
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z)-5-(4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl)-2-methylpent-2-en-1-ol
- Reference substance name:
- (2E)-2-methyl-6-[(1S)-4-methylcyclohex-3-en-1-yl]hepta-2,6-dien-1-ol
- Cas Number:
- 942226-77-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- (2E)-2-methyl-6-[(1S)-4-methylcyclohex-3-en-1-yl]hepta-2,6-dien-1-ol
- Reference substance name:
- (Z)-2-Methyl-5-((1R,2R,4S)-2-methyl-3-methylenebicyclo[2.2.1]heptan-2-yl)pent-2-en-1-ol
- Cas Number:
- 79081-90-6
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z)-2-Methyl-5-((1R,2R,4S)-2-methyl-3-methylenebicyclo[2.2.1]heptan-2-yl)pent-2-en-1-ol
- Test material form:
- liquid
- Details on test material:
- Batch No.: 2582250
Production Date: 4/11/2016
Expiry Date: 4/11/2018
Storage Conditions at Test Facility:At 20 +/- 5°C, in the dark
Aggregate State at Room Temperature: Liquid
Colour: Light yellowish
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Robertet / 2582250
- Appearance: Colorless to pale yellow liquid
- Manufacturing date: 04 November 2016
- Date received: 27 January 2017
- Expiration date of the lot/batch: 04 November 2018
- Purity test date: 10 February 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, darkness
Test animals / tissue source
- Species:
- other: reconstructed human cornea-like epithelium tissues
- Details on test animals or tissues and environmental conditions:
- - Description of the cell system used:
Reconstructed human Cornea-like Epithelium (RhCE) tissue constructs: The 0.60 cm² Reconstructed human Cornea-like Epithelia (EpiOcularTM OCL-212-ver2.0, supplied by MatTek Corporation, batch No. 23770) were received on 08 March 2017.
The killed Reconstructed human Cornea-like Epithelia (EpiOcularTM OCL-212-ver2.0, supplied by MatTek Corporation, batch No. 23706) were defrost on 03 March 2017, re-freeze on 03 March 2017 and defrost to be used on 08 March 2017.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- 30 minutes at 37 °C, 5% CO2, 95% humidity (standard culture conditions).
- Duration of post- treatment incubation (in vitro):
- After 30 minutes of exposure, extensive rinsing with DPBS at room temperature, a 12 minutes post-exposure immersion period at room temperature and a 2 hours and 03 minutes post-exposure incubation at standard culture conditions.
- Number of animals or in vitro replicates:
- Test item, negative and positive controls were applied on duplicate tissues (2 living RhCE tissue replicates and 2 killed DPBS pre-treated Reconstructed human Cornea-like Epithelia tissue replicates).
- Details on study design:
- - RhCE tissue construct used, including batch number: The 0.60 cm² Reconstructed human Cornea-like Epithelia (EpiOcularTM OCL-212-ver2.0, supplied by MatTek Corporation, batch No. 23770) were received on 08 March 2017. The killed Reconstructed human Cornea-like Epithelia (EpiOcularTM OCL-212-ver2.0, supplied by MatTek Corporation, batch No. 23706) were defrost on 03 March 2017, re-freeze on 03 March 2017 and defrost to be used on 08 March 2017.
The same day, the 12 tissues in their 24-well shipping container were equilibrated at room temperature for 15 minutes. Then the inserts (filter + epithelium) were gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. They were placed in 6 wells culture plate which had been previously filled with 1 mL of 37 °C pre-warmed assay medium (MatTek Corporation, batch No. 030617MGKA) and incubated during 19 hours and 55 minutes at standard culture conditions.
- Evaluation of direct interaction with MTT: The direct interaction of MTT with the test item was checked by adding 16 µL of the test item to 300 µL of solution of MTT at 1 mg/mL. A yellow solution with purple spots on the surface was observed after 3 hours of incubation between 36.3 °C and 37.6 °C, 5% CO2. Therefore, the test item was identified as a direct MTT reducer and two killed control tissue models were added to the study which underwent the entire testing procedure to generate a non-specific MTT reduction control.
- Doses of test chemical and control substances used: 50 μL of test substance, negative or positive controls used.
- Pre-treatment: After the overnight incubation, the tissues were pre-wetted with 20 μL of Ca2+Mg2+Free-DPBS. The tissues were incubated at standard culture conditions for 30 minutes.
Treatment of tissues
Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods:
- The test item was applied, as supplied, at the dose of 50 μL, to the entire surface of 2 living RhCE tissue replicates and 2 killed DPBS pre-treated Reconstructed human Cornea-like Epithelia tissue replicates during 30 minutes at standard culture conditions. In the same experimental conditions, the positive and negative controls were carried out.
- After the treatment, the test item and control substances were carefully washed from the RhCE tissues by extensive rinsing with Ca2+Mg2+Free-DPBS. The rinsed tissues were checked for any coloration and noted to be of comparable colour with the negative control treated tissues (whitish). This rinsing step was followed by a 12-minute post-exposure immersion period at room temperature in 5 mL of fresh medium to remove any test item absorbed into the tissue. The RhCE constructs were then incubated for a 2 hours and 03 minutes post-exposure incubation at standard culture conditions in 1 mL of fresh medium at 37 °C, 5% CO2.
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable):
The spectral properties at 570 nm of test item in isopropanol were checked by adding 16 µL of the test item to 1.5 mL of isopropanol (same conditions as in the main test). A yellowish solution was obtained after 2 hours of incubation at ambient temperature with gentle shaking. The mean of the corrected OD (Optical density) (blank subtracted) was 0.000 which is less than 0.08 (value corresponding to approximately twice the OD of the extracting solvent). Therefore the test item was considered not to interfere with the MTT assay and there was no need to add non-specific coloration controls to the study.
- Cell viability measurements: Following the exposure to the test item, viability measurements are performed immediately after the post-exposure incubation period of the rinsed tissues in fresh medium. This period allows both for recovery from weak cytotoxic effects and for appearance of clear cytotoxic effects. The RhCE tissue viability was measured by enzymatic conversion of the vital dye MTT by the viable cells of the tissue into a blue MTT formazan salt that is quantitatively measured after extraction from tissues.
- Optical Density measurements: The RhCE constructs were placed in 300 µL of a MTT solution at 1.0 mg/mL for 3 hours and 05 minutes at standard culture conditions. The precipitated blue formazan product was then extracted from the tissues by placing each insert in 2 mL of isopropanol during 17 hours and 28 minutes at 6±3 °C in the dark. The concentration of formazan was measured by determining the OD at 570 nm, just after dilution of the extractions in isopropanol (1:2). The OD at 570 nm was measured in triplicate samples of formazan extracts. The measured OD are proportional to the number of living cells. The measurement of OD was performed using the ELx800 absorbance microplate reader (controlled every year and calibrated if necessary) supplied by BioTek and the validated software Gen5 ELISA V1.05.11 supplied by BioTek.
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model: The OD values obtained with the replicate tissue extracts for each test item were used to calculate the mean percent tissue viability normalized to the negative control, which was set to 100%. The percentage tissue viability cut-off value distinguishing classified from non-classified test items is 60%. Results are interpreted as follows:
The test item is identified as not requiring classification and labelling according to UN GHS No Category: if the mean percent tissue viability after exposure and post-exposure incubation is > 60%. In this case, no further testing in other test methods is required.
The test item is identified as potentially requiring classification and labelling according to UN GHS (Category 2 or Category 1): if the mean percent tissue viability after exposure and post-exposure incubation is ≤ 60%.
When the final mean percent tissue viability is ≤ 60%, further testing with other test methods will be required because the RhCE test method shows a certain number of false positive results and cannot resolve between UN GHS Categories 1 and 2.
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria: The mean percent tissue viabilities obtained with the positive control and negative controls are within the range of historical data and therefore validate the experiment.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % mean viability of the tissues
- Run / experiment:
- Main test - 30 minutes
- Value:
- 73.93
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- MEAN PERCENT TISSUE VIABILITIES
- The mean corrected percent tissue viability of the RhCE replicates treated with the test item was 73.93 %, versus 39.16% in the positive control (Methyl acetate).
ACCEPTANCE OF RESULTS:
- The mean percent tissue viabilities obtained with the positive control and negative controls are within the range of historical data and therefore validate the experiment.
Any other information on results incl. tables
Table 7.3.2/1: Assessment of the eye irritation potential individual and average values of OD after 30 minutes exposure
Items |
Tissues |
OD |
Mean OD/disc# |
Mean OD / product |
Viability% |
Mean viability% |
Difference of viability% |
Conclusion |
Negative control |
1 |
0.947 |
0.912 |
0.959 |
95.10 |
100.00 |
9.80 |
- |
0.902 |
||||||||
0.887 |
||||||||
2 |
1.162 |
1.006 |
104.90 |
|||||
0.966 |
||||||||
0.891 |
||||||||
Positive control |
3 |
0.318 |
0.366 |
0.376 |
38.16 |
39.16 |
1.98 |
UN GHS category 2 or 1 |
0.372 |
||||||||
0.408 |
||||||||
4 |
0.382 |
0.385 |
40.15 |
|||||
0.394 |
||||||||
0.379 |
||||||||
Test item |
5 |
0.806 |
0.768 |
0.767 |
80.083 |
79.98 |
0.21 |
- |
0.758 |
||||||||
0.739 |
||||||||
6 |
0.791 |
0.766 |
79.875 |
|||||
0.753 |
||||||||
0.753 |
||||||||
Test item killed control |
9 |
0.054 |
0.057 |
0.058 |
5.944 |
6.05 |
0.21 |
|
0.055 |
||||||||
0.061 |
||||||||
10 |
0.061 |
0.059 |
6.152 |
|||||
0.058 |
||||||||
0.057 |
||||||||
Test item corrected |
- |
73.93 |
- |
No category |
#: mean of 3 values (triplicate of the same extract)
OD: optical density
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category.
- Executive summary:
An in vitro eye irritation test, reconstructed human cornea-like epithelium tissues (EpiOcularTM tissue model) was performed according to the OECD Guideline 492 and in compliance with GLP to evaluate the eye hazard potential of the test item Sandalwood Austrocaledonien Oil.
The test item was applied, as supplied, at the dose of 50 µL, to 2 living and 2 killed DPBS pre-treated RhCE (EpiOcularTM tissue model) during 30 minutes at 37 °C, 5% CO2, 95% humidity (standard culture conditions). The exposure period was followed by extensive rinsing with DPBS at room temperature, a 12 minutes post-exposure immersion period at room temperature and a 2 hours and 03 minutes post-exposure incubation at standard culture conditions. The tissue viability was measured by performing an MTT assay.
The mean corrected percent tissue viability of the RhCE replicates treated with the test item was 73.93 %, versus 39.16% in the positive control (Methyl acetate). The mean percent tissue viabilities obtained with the positive control and negative controls are within the range of historical data and therefore validate the experiment.
In conclusion, under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category.
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