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Diss Factsheets
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EC number: 950-969-7 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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:
- 2019
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Santalene oil: fermentation products of glucose with santalene synthase modified Rhodobacter sphaeroides, distilled
- EC Number:
- 950-969-7
- Molecular formula:
- not applicable
- IUPAC Name:
- Santalene oil: fermentation products of glucose with santalene synthase modified Rhodobacter sphaeroides, distilled
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method (EIT) and considerations regarding applicability: according to the Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation
-Test system: Three-dimensional human cornea model (EpiOcular (TM), i.e. a non-keratinized tissue construct composed of normal human-derived epidermal keratinocytes (surface 0.6 cm²).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- other: MTT reduction control (freeze-killed control tissues) applied with sterile deionized water or undiluted test substance
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL
- Concentration: undiluted test substance - Duration of treatment / exposure:
- 30 min
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Details of the test procedure used:
-Two EpiOcular TM tissues were pretreated for 30 minutes with 20 µL PBS to wet the tissue surface. The tissues were incubated at standard culture conditions. Thereafter, the tissues were treated with 50 µL undiluted test substance, covering the whole tissue surface for 30 minutes followed by a 2-hour post-incubation period.
- Number of tissue replicates used per test chemical and controls (positive control, negative control): 2 tissues each
- Due to the ability of the test substance to reduce MTT directly, freeze killed control tissues were treated with negative control and test substances (2 tissues each) in parallel.
- Induced cytotoxicity (= loss of viability) is measured by a colorimetric (MTT) assay, i.e. a reduction of mitochondrial dehydrogenase activity to reduce 3-[4, 5-d imethylthiazol-2-yl]-2 ,5-diphenyltetrazolium bromide (MTT) to the insoluble blue-colored formazan. After isopropanol extraction of the formazan from the tissues, the optical density of the extract is determined spectrophotometrically (wavelenght 570 nm). Optical density of the extracts of the tissues treated with the test substance is compared to values from negative control tissues and expressed as relative tissue viability.
Evaluation of results:
- The irritation potential of the test material is predicted from the mean relative tissue viabilities compared to the negative control tissues treated concurrently with sterile water.
- A chemical is considered as "non-irritant" (no UN GHS Category) if the mean relative tissue viability with a test material is greater than 60%.
- No prediction can be made, if the mean relative tissue viability with a test material is less or equal to 60%. Further testing with other test methods (e.g. BCOP) is required, because the EpiOcular EIT shows a
certain number of false positive results and cannot resolve between UN GHS Categories 1 and 2.
- In case of borderline results such as non-concordant replicate measurements and/or mean percent tissue viability equal to ± 5% of the cut-off value, a second test should be considered as well as a third test in case of discordant results between the first two tests. A "borderline" evaluation (60 ± 5%) was determined statistically using historical data of the performing laboratory and hence considers the variance of the test method. This evaluation is confirming the borderline range provided in OECD Guideline 492.
- A single test composed of at least 2 tissue replicates is considered sufficient for a test chemical when the result is unequivocal.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent tissue viability
- Remarks:
- compared to negative controls
- Run / experiment:
- viable tissue 1
- Value:
- 98.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent tissue viability
- Remarks:
- compared to negative controls
- Run / experiment:
- viable tissue 2
- Value:
- 102.7
- 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:
- OTHER EFFECTS:
- Direct MTT reduction: The test substance is able to reduce MTT directly. Therefore, additional MTT reduction controls (freeze-killed control tissues) were applied concurrently with 50 µL sterile deionized water or with 50 µL undiluted test substance to 2 tissues each. The results of the freeze-killed control tissues indicate an increased MTT reduction (relative mean tissue viability 0.1 % of the negative control). Thus, for the test substance, the final mean viability is given after killed control correction.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
Historic control values of negative and positive controls were collected over an appropriate period. These data demonstrate the reproducibility of results and robustness of the procedures used.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
For details on results, please see table 1 in section "Attached background material".
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present in vitro study, it was concluded that the test substance does not show an eye irritation potential.
- Executive summary:
In the present study, the eye irritation potential of the test substance was investigated in accordance with TG OECD 492 (Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage).
Two EpiOcular™ tissues were treated with 50 µL undiluted test substance, covering the whole tissue surface for 30 minutes followed by a 2-hour post-incubation period, and a subsequent cell viability (MTT) test. In addition to the test substance, control tissues were applied concurrently with 50 µL sterile deionized water as negative control or with 50 µL methyl acetate as positive control to 2 tissues each. The optical density of the extracts of the tissues treated with the test substance was compared to negative control values, expressed as relative tissue viability. Based on the result of a pretest, the test substance is able to reduce MTT directly. Thus, two freeze-killed control tissues were treated additionally with each the test item and the negative control in the same way as the viable tissues. The results of the freeze-killed control tissues indicate an increased MTT reduction (relative mean tissue viability 0.1 % of the negative controls). Thus, the final mean viability values for test substance treated tissues were corrected accordingly.
Incubation of the reconstituted tissues with the test substance resulted in a mean viability of 100.6% (+/- 4.3% inter-tissue variability) compared to respective control tissue viabilities. Treatment with the positive control resulted in a mean viability of 20.7% (+/- 7.0% inter-tissue variability) compared to respective control tissue viabilities.
Based on the results observed in the EpiOcular™ test alone and by applying the evaluation criteria, it was concluded that the test substance does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
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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