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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 2020- Mar2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation (if applicable): 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1
- Observable damage in the tissue due to washing: No
DYE BINDING METHOD
- Dye used in the dye-binding assay [none / MTT / Sulforhodamine B / other]: MTT
- Spectrophotometer: Microtiter plate photometer
- Wavelength: 570 nm
EXPERIMENTS TO DERIVE FINAL PREDICTION:
One valid experiment and three additional pre-tests
DECISION CRITERIA
% Tissue viability is ≤ 50 % of negative control - Corrosive/Irritant to skin - UN GHS Category 1 or 2
% Tissue viability is > 50% of negative control - Non-irritant to skin - No Category for Skin Irritation - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Pyrolytic lignin
- Concentration (if solution): 30 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)
NEGATIVE CONTROL
- Dulbecco’s Phosphate Buffered Saline (DPBS buffer without CaCl2 and without MgCl2)
- Concentration (if solution): 30 µL
POSITIVE CONTROL
- Solution of demineralised water containing 5% Sodium dodecyl sulphate (SDS)
- Concentration (if solution): 30 µL - Duration of treatment / exposure:
- 1 hour main test
- Duration of post-treatment incubation (if applicable):
- 43 hours in total (25 hours after DPBS rinse and assay medium application and 18 hours after medium renewal) on main test
- Number of replicates:
- 3 replicates for main test
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test
- Value:
- 61.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test (Corrected Values)
- Value:
- 57.6
- 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:
- Visible damage on test system: No
PRE-TEST
- Direct-MTT reduction: Yes
The test item was tested for the ability of direct MTT reduction. The MTT solution turns blue/purple within 1 hour. Therefore, direct MTT reduction by the test item had taken place and an additional test was necessary.
- Additional Test Direct Reduction of MTT with freeze killed Tissues: Yes
Two freeze-killed tissues treated with the MTT reducing test item and two untreated killed tissues that showed the small amount of MTT reduction due to residual NADH and associated enzymes within the killed tissues. Therefore, direct MTT reduction had taken place and data correction with the main test was necessary.
- Colour interference with MTT: No
It was tested whether the test item develops a colour without MTT addition as the solution showed no significant change in colour, no binding capacity had to be tested.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The validity of the skin irritation study at LAUS GmbH was demonstrated in a non-GLP proficiency study. For this purpose, 10 proficiency chemicals (indicated by the OECD 439 guideline) were tested. All of the 10 proficiency chemicals were correctly categorized. Therefore, the proficiency of the skin irritation study was demonstrated.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Negative control Optical Density (OD )≥ 0.8 and ≤ 2.8
- Acceptance criteria met for positive control: % tissue viability of positive control SDS ≤ 20% of negative control
- Acceptance criteria met for variability between replicate measurements: SD of mean viability of the tissue replicates ≤ 18%
Any other information on results incl. tables
Mean Absorbance Values (main test)
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.264 |
0.753 |
0.066 |
Mean – blank (tissue 2) |
1.337 |
0.778 |
0.073 |
Mean – blank (tissue 3) |
1.456 |
0.968 |
0.075 |
Mean of the three tissues |
1.352 |
0.833 |
0.071 |
% Tissue Viability (main test)
Designation |
Test ItemBTG Pyrolytic Lignin |
Positive Control |
% Tissue viability (tissue 1) |
55.7% |
4.9% |
% Tissue viability (tissue 2) |
57.5% |
5.4% |
% Tissue viability (tissue 3) |
71.6% |
5.5% |
% Tissue viability (mean) |
61.6% |
5.3% |
± SD of mean tissue viability (%) |
8.7% |
0.3% |
Mean Absorbance Values (corrected with freeze killed control)
Designation |
Negative Control |
Test Item |
Mean – blank (tissue 1) |
1.264 |
0.699 |
Mean – blank (tissue 2) |
1.337 |
0.724 |
Mean – blank (tissue 3) |
1.456 |
0.914 |
Mean of the three tissues |
1.352 |
0.779 |
% Tissue Viability (corrected with freeze killed control)
Designation |
Test Item |
% Tissue viability (tissue 1) |
51.7% |
% Tissue viability (tissue 2) |
53.6% |
% Tissue viability (tissue 3) |
67.6% |
% Tissue viability (mean) |
57.6% |
± SD of mean tissue viability (%) |
8.7% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Pyrolytic Lignin is considered non-irritant to skin in the Recon-structed human Epidermis (RhE) Test Method.
- Executive summary:
This in vitro study was performed in order to evaluate the potential of Pyrolytic Lignin to evoke skin irritation in a reconstructed human epidermis (RhE) test method. The test consists of a topical exposure of the neat test item to a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, 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 skin irritation potential. The study was conducted following the OECD Guideline 439 and the EU method B.46. A valid experiment (main test) with additional test were performed. The additional tests included an assessment of coloured or staining test item to test whether the test item develops a colour without MTT addition, that showed no significant change in colour; an assessment to test the potetntial of the test item of direct reduction of MTT. As the test item was capable of reducting MTT and additional direct reduction of MTT tes was performed with freeze killed tissues. Because direct MTT reduction took place, data correction for the results of the main test was necessary.
In the main test, tissues of the human skin model EpiDermTM were treated with the test item for 60 minutes. After the treatment with the test item, the mean value of relative tissue viability was reduced to 57.6% after correction. This value is above the threshold for skin irritation potential (50%). Therefore, the test item BTG Pyrolytic Lignin is considered non-irritant to skin.
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