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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | 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:
- 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Low molecular weight organic substances from fast pyrolysis bio-oil
- IUPAC Name:
- Low molecular weight organic substances from fast pyrolysis bio-oil
- Reference substance name:
- Monomers from fast pyrolysis bio-oil
- IUPAC Name:
- Monomers from fast pyrolysis bio-oil
- Reference substance name:
- Dimers from fast pyrolysis bio-oil
- IUPAC Name:
- Dimers from fast pyrolysis bio-oil
- Reference substance name:
- Trimers from fast pyrolysis bio-oil
- IUPAC Name:
- Trimers from fast pyrolysis bio-oil
- Reference substance name:
- Higher oligomers from fast pyrolysis bio-oil
- IUPAC Name:
- Higher oligomers from fast pyrolysis bio-oil
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid: viscous
- Remarks:
- Brown /black highly vicous liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Test animals / tissue source
- Species:
- other: EpiOcularTM tissue. Human-derived keratinocytes
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Pyrolytic lignin
- Concentration (if solution): 50 μL
MTT ASSAY
- 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide (MTT)
- Concentration (if solution): 300 μL (1 mg/ml MTT in Dulbecco’s Phosphate-Buffered Saline (DPBS buffer) and 8mL of medium) - Duration of treatment / exposure:
- 1 hour main test
180 min MTT assay - Duration of post- treatment incubation (in vitro):
- 120 min
- Details on study design:
- NUMBER OF REPLICATES: 2
NEGATIVE CONTROL USED: Sterile demineralised water
POSITIVE CONTROL USED : Methyl acetate
APPLICATION DOSE AND EXPOSURE TIME: Test material 50 μL, 30 minutes exposure. MTT Solution 300 μL, 180 minutes exposure
REMOVAL OF TEST SUBSTANCE
- Dulbecco`s Phosphate Buffered Saline (DPBS) used for test item
- Number of washing steps after exposure period: 1 rinse
- POST-EXPOSURE INCUBATION: 120 minutes
METHODS FOR MEASURED ENDPOINTS:
- Optical density (OD): Measurement of MTT formazan precipitate extracted with isopropanol on the MTT assay after main test with a spectrophotometer at 570 nm.
DECISION CRITERIA:
% Viability > 60% - Non eye irritant - No UN GHS classification
% Viability ≤ 60 % - At least eye irritant - No prediction can be made for UN GHS classification
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- Main test
- Value:
- 49.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: The validity of the EpiOcularTM test at LAUS GmbH was demonstrated in a non-GLP pro-ficiency study. For this purpose 15 proficiency chemicals (indicated by the OECD 492 guideline) were tested. All of the 15 proficiency chemicals were correctly categorized. Therefore, the proficiency of the EpiOcularTM test was demonstrated
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Mean OD of negative control is >0.8 and <2.8
- Acceptance criteria met for positive control: % Mean relative viability of positive control is < 50% of negative control
- Acceptance criteria met for variability between replicate measurements: Variation within replicates is < 20%
Any other information on results incl. tables
Mean Absorbance Negative Control, Positive Control and Test Item
Designation |
Negative Control |
Positive Control |
Test Item |
Mean – blank (Tissue 1) |
1.944 |
0.774 |
0.959 |
Mean – blank (Tissue 2) |
1.997 |
0.619 |
0.992 |
% Viability Positive Control and Test Item
Designation |
Positive Control |
Test Item |
% Viability (Tissue 1) |
39.2% |
48.6% |
% Viability (Tissue 2) |
31.4% |
50.3% |
% Viability Mean |
35.3% |
49.5% |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- According to the OECD Guideline 492, the EpiOcularTM Eye Irritation Test does not allow discrimination between eye irritation/reversible effects on the eye (Category 2) and seri-ous eye damage/irreversible effects on the eye (Category 1)
- Conclusions:
- Under the conditions of the test, BTG Pyrolytic Lignin is considered either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test.
- Executive summary:
The study was performed in order to evaluate the eye hazard potential of BTG Pyrolytic Lignin in a Reconstructed human Cornea-like Epithelium (RhCE) model in an in vitro study (e.g. EpiOcularTM Eye Irritation Test). The EpiOcularTM Eye Irritation Test (EIT) predicts the acute eye hazard potential of chemicals by measurement of tissue damage caused by cytotoxic effects in the reconstructed human cornea-like tissue model. The EpiOcular™ EIT can be used to identify chemicals that do not require classification for eye irritation or serious eye damage according to the UN GHS classification system. A limitation of this guideline is that it neither allows discrimination between eye irritation/reversible effects on the eye (Category 2) and serious eye damage/irreversible effects on the eye (Category 1), nor between eye irritants (optional Category 2A) and mild eye irritants (optional Category 2B).
The liquid test item was applied topically to a three-dimensional RhCE tissue construct in duplicate for an exposure time of 30 minutes.Eye hazard materials are identified by their ability to produce a decrease in cell viability as determined. The cell viability is measured by dehydrogenase conversion of MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide), present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated negative controls is used to predict the eye irritation potential. After treatment with the test item, the mean value of relative tissue viability was 49.5%. This value is below the threshold for eye irritation potential (≤ 60%) and therefore the test item is considered either eye irritant or inducing serious eye damage.
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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