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EC number: 947-964-7 | 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
- Study period:
- 2018-10-10 to 2018-10-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 25 June 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pyrolysis Reaction Product of Pinane
- EC Number:
- 947-964-7
- Molecular formula:
- n. a. for UVCB
- IUPAC Name:
- Pyrolysis Reaction Product of Pinane
Constituent 1
Test animals / tissue source
- Species:
- other: human cornea model
- Details on test animals or tissues and environmental conditions:
- The EpiOcular™ Eye Irritation Test (EIT) was validated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and Cosmetics Europe between 2008 and 2013. From this validation study and its independent peer review it was concluded that the EpiOcular™ EIT is able to correctly identify chemicals (both substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage according to UN GHS, and the test method was recommended as scientifically valid for that purpose.
The EpiOcular™ human cell construct (MatTek Corporation) is used in this assay. This three-dimensional human cornea model allows the identification of a test item's potential to induce eye irritation or serious eye damage by assessing cell viability after treatment. The model is composed of stratified human keratinocytes in a three-dimensional structure, consisting of at least three viable layers of cells. Test materials can be applied topically to the model so that also water insoluble materials may be tested. Prior to use, each plate (6, 12, and 24-well) and its cover will be uniquely identified with a permanent marker by a plate number and/or test article number.
The cytotoxicity of the test article (and thus the ocular irritation potential) is evaluated by the relative viability of the treated tissues in comparison to the negative control-treated tissues. Viability is determined by the NAD(P)H-dependent microsomal enzyme reduction of MTT (and to a lesser extent, by the succinate dehydrogenase reduction of MTT) in control and test article-treated cultures (Berridge, et al., 1996). Data are presented in the form of relative survival (relative MTT conversion).
Supplier: MatTek In Vitro Life Science Laboratories Mlynské Nivy 73, Bratislava, Slovakia
Lot No.: 27073
Expiry date: 11 October 2018
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 μL (or a sufficient amount to cover uniformly the entire tissue surface)
- Duration of treatment / exposure:
- The plates with the treated tissue units were incubated for the exposure time of 30 ± 2 minutes at standard culture conditions (37±2°C in an incubator with 5 % CO2, ≥95% humidified atmosphere).
- Duration of post- treatment incubation (in vitro):
- 120 ± 15 minutes
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- RhCE tissue construct used:
EpiOcular™ human cell construct (MatTek Corporation), Lot No.: 27073
- Duration and temperature of:
exposure: 30 ± 2 minutes at standard culture conditions (37±2°C in an incubator with 5 % CO2, ≥95% humidified atmosphere)
post-exposure immersion: 12 ± 2 minutes immersion incubation (Post-Soak) at room temperature
post-exposure incubation: 120 ± 15 minutes at standard culture conditions
- Number of tissue replicates used per test chemical and controls: 2
- Wavelength used for quantifying MTT formazan: 570 nm (± 10 nm; Read out range: 0-3.5 Abs, Linearity range: 0.2136 – 3.1752)
- Description of the method used to quantify MTT formazan :
After the post-incubation the EpiOcular™ units were transferred into the MTT ready to use solution filled 24-well plate (300 μL of 1 mg/mL MTT per well) and then incubated for 3 hours (± 15 min) at 37±2°C in an incubator with 5±1 % CO2 protected from light, ≥95% humidified atmosphere. Each insert was removed from the 24-well plate after 3 hours ± 15 minutes, the bottom of the insert was blotted on absorbent material, and then transferred to a pre-labeled 24-well plate containing 2 mL of isopropanol in each designated well so that isopropanol was flowing into the insert on the tissue surface. The plates were sealed with parafilm (between the plate cover and upper edge of the wells) and were stored overnight at 4-10°C in the dark.
To extract the MTT, the plates were placed on an orbital plate shaker and shaken (120 rpm) for approximately 3 hours at room temperature, protect from light. At the end of the extraction period, the tissue was pierced and the liquid within each insert was decanted into the well from which it was taken. Following the formazan extraction, 200 μL sample(s) from each tube (preferably 2×200 μL if possible) was placed into the wells of a 96-well plate (labelled appropriately) and Absorbance / Optical Density of the samples was determined in a 96-well plate spectrophotometer at the wavelength of 570 nm.
- Description of evaluation criteria used: The test chemical is identified as 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 less than or equal (≤) to 60% of the negative control
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals
Prior to routine use of the method Toxi-Coop ZRT. demonstrated the technical proficiency in a separate study (study no.: 392-492-1722) using the fifteen proficiency chemicals according to OECD Test Guideline No. 492.
- Acceptable variability between tissue replicates for positive and negative controls :
The mean OD value of the two negative control tissues should be between 0.8 and 2.5.
The acceptable percentage viability for positive control (mean of two tissues) is:
- 30 minute exposure: below 50% of control viability
- 6 hours exposure: below 50% of control viability
- Acceptable variability between tissue replicates for the test chemical
The difference of viability between the two relating tissues of a single chemical is < 20% in the same run (for positive and negative control tissues and tissues of single chemicals). This applies also to the killed controls (single chemicals and negative killed control) and the colourant controls which are calculated as percent values related to the viability of the relating negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % viability
- Run / experiment:
- 1, mean of two replicates
- Value:
- 93
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
OD values and viability percentages of the controls:
|
OD values and viability percentages of the test item:
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained from this in vitro eye irritation test, using the EpiOcular™ model, indicated that the test item reveals no eye irritation/corrosion potential under the applied testing conditions and is considered as not requiring classification and labelling according to UN GHS (UN GHS No Category).
- Executive summary:
A study according to OECD Guideline 492 was conducted to determine the acute ocular irritation potential of the test item on three-dimensional RhCE tissue in the EpiOcular™ model in vitro. Before treatment the tissues were pre-wetted with approximately 20 μL of Ca++Mg++Free-DPBS and were incubated at standard culture conditions for 30 ± 2 minutes. Disks of EpiOcular™ (two units) were treated with test item (50 μL/units) and incubated for 30 ± 2 minutes at standard culture conditions (37±2°C in an incubator with 5±1% CO2, ≥95% humidified atmosphere). Exposure of test material was terminated by rinsing with Ca++Mg++ Free-DPBS solution. After rinsing, the tissues were incubated for a 12 ± 2 minutes immersion incubation (Post-Soak) at room temperature. At the end of the Post-Soak immersion test items treated tissues were incubated for 120 ± 15 minutes at standard culture conditions (Post-treatment Incubation). Fresh assay medium was used during the Post-Soak and Post-incubation. The viability of each disk was assessed by incubating the tissues for 3 hours (±15 min) with MTT solution at 37±2°C in an incubator with 5±1% CO2 protected from light, ≥95% humidified atmosphere. The formazan precipitated was then extracted using isopropanol and quantified spectrophotometrically. Sterile deionized water and methyl acetate treated tissues were used as negative and positive controls respectively. The Disks of EpiOcular™ (two units / control) were treated with positive and negative control and incubated 30 ± 2 minutes. The test item did not show significantly reduced cell viability in comparison to the negative control (mean viability: 93 %). All obtained test item viability results were above 60 % when compared to the viability values obtained from the negative control. Therefore the test item was considered to be non-irritant to the eye. Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.
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