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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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan- Mar 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: EU-Method B.40 BIS. “in vitro skin corrosion: Human skin model test"
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,6-anhydro-β-D-glucose
- EC Number:
- 207-855-0
- EC Name:
- 1,6-anhydro-β-D-glucose
- Cas Number:
- 498-07-7
- Molecular formula:
- C6H10O5
- IUPAC Name:
- (1R,2S,3S,4R,5R)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol
- Reference substance name:
- Glycollaldehyde
- EC Number:
- 205-484-9
- EC Name:
- Glycollaldehyde
- Cas Number:
- 141-46-8
- Molecular formula:
- C2H4O2
- IUPAC Name:
- 2-hydroxyacetaldehyde
- Reference substance name:
- Organic acids
- IUPAC Name:
- Organic acids
- Reference substance name:
- Ketones
- IUPAC Name:
- Ketones
- Reference substance name:
- Phenols
- IUPAC Name:
- Phenols
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Oligomers of sugars and anhydrosugars
- IUPAC Name:
- Oligomers of sugars and anhydrosugars
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
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
DYE BINDING METHOD
- Dye used in the dye-binding assay: [none / MTT / Sulforhodamine B / other:] MTT
- Spectrophotometer: Microtiter plate photometer
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
One valid experiment and two additional pre-test
VALIDITY OF EXPERIMENT
- Mean OD of the tissue replicates treated with the negative control (H2O) should be ≥0.8 and ≤2.8 for every exposure time
- Mean viability of the tissue replicates exposed for 1 hour with the positive control (8N KOH), expressed as % of the negative control, should be ≤ 15%
- In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%
DECISION CRITERIA
- The test substance is considered to be corrosive to skin if:
% tissue viability after 3 min. incubation time is < 50% of negative control and % tissue viability after 1h. incubation time is irrelevant
% tissue viability after 3 min. incubation time is ≥ 50% of negative control and % tissue viability after 1h. incubation time is < 15% of negative control
- For substance considered corrosive:
% tissue viability after 3 min. incubation time is < 25% of negative control and % tissue viability after 1h. incubation time is irrelevant - GHS Skin Corrisive Sub-category 1A
% tissue viability after 3 min. incubation time is ≥ 25% of negative control and % tissue viability after 1h. incubation time is irrelevant - GHS Skin Corrisive Sub-category 1B or 1C
- The test substance is considered to be non-corrosive to skin if:
% tissue viability after 3 min. incubation time is ≥ 50% of negative control and % tissue viability after 1h. incubation time is ≥ 15% of negative control - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Pyrolytic sugar
- Concentration (if solution): 50µL
MTT ASSAY
- 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide (MTT)
- Concentration (if solution): 1mL MTT solution (5 mg/mL MTT, in Dulbecco’s Phosphate-Buffered Saline (DPBS buffer))
NEGATIVE CONTROL
- Demineralised water
- Concentration (if solution): 50µL
POSITIVE CONTROL
- KOH solution in demineralised water
- Concentration (if solution): 50µL - Duration of treatment / exposure:
- 3 minutes with one human skin model
1 hour with a second human skin model - Number of replicates:
- 2 replicates per human skin model
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min experiment of main test
- Value:
- 93.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour experiment of main test
- Value:
- 72.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min experiment corrected values of main test
- Value:
- 16.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour experiment corrected values of main test
- Value:
- 6.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- CORRECTED VALUES OF MAIN TEST
As the test item had shown its ability to reduce MTT in the Direct-MTT reduction pre-test. Corrections were made on the final % tissue viability from the main test. The true tissue viability is calculated as the percentage tissue viability obtained with living tissues exposed to the MTT reducer, minus the percent not specific MTT reduction obtained with the killed tissues exposed to the same MTT reducer, calculated relative to the negative control run concurrently to the test being corrected.
OTHER EFFECTS
- Visible damage on test system: No
PRE TESTS
- Direct-MTT reduction: Yes
The MTT solution showed a significant change in colour within 1 hour. Therefore, a functional test with freeze killed tissues that possess no metabolic activity was performed.
Two freeze-killed tissues were treated with the MTT reducing test item for 3 minutes and 1 hour and two untreated killed tissues for 3 minutes and 1 hour.
- Colour interference with MTT: No
It was tested whether the test item develops a colour without MTT addition. The resulting suspension was coloured red brown and thereforethe binding capacity of the test item to the tissue was tested. As the stained control result was ≤ 5 % of the viable negative control, data correction procedure is not necessary.
Any other information on results incl. tables
Mean Absorbance Values of the 3 Minutes Experiment of the main test
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.648 |
1.478 |
0.362 |
Mean – blank (tissue 2) |
1.724 |
1.676 |
0.376 |
Mean of the two tissues |
1.686 |
1.577 |
0.369 |
RSD |
3.2% |
8.9% |
2.6% |
Mean Absorbance Values of the 1 h Experiment of the main
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.536 |
1.182 |
0.108 |
Mean – blank (tissue 2) |
1.816 |
1.259 |
0.079 |
Mean of the two tissues |
1.676 |
1.220 |
0.093 |
RSD |
11.8% |
4.5% |
22.0% |
% Tissue Viability of the Main test
Incubation |
Test Item |
Positive Control |
3 min |
93.5% |
21.9% |
1 h |
72.8% |
5.6% |
Mean Absorbance Values of the 3 Minutes Experiment of the Direct Reduction of MTT test
Designation |
Negative Control |
Test Item |
Mean – blank (tissue 1) |
0.080 |
1.342 |
Mean – blank (tissue 2) |
0.083 |
1.418 |
Mean of the two tissues |
0.082 |
1.380 |
RSD |
2.6% |
3.9% |
Mean Absorbance Values of the 1 h Experiment of the Direct Reduction of MTT test
Designation |
Negative Control |
Test Item |
Mean – blank (tissue 1) |
0.079 |
1.310 |
Mean – blank (tissue 2) |
0.082 |
1.071 |
Mean of the two tissues |
0.081 |
1.190 |
RSD |
2.9% |
14.2% |
Corrected Absorbance Values (OD 570 nm) and viabilty
Designation |
3 Minutes Experiment |
1 hour Experiment |
Mean absorbance test item additional test |
1.380 |
1.190 |
Mean absorbance negative control additional test |
0.082 |
0.081 |
Mean difference absorbance |
1.298 |
1.110 |
% Viability mean additional test in comparison to the negative control of the main test |
77.0% |
66.2% |
|
||
Corrected absorbance in the additional test |
0.279 |
0.110 |
Corrected% Viability |
16.5% |
6.6% |
Applicant's summary and conclusion
- Interpretation of results:
- other: the study alone does not allow conclusion on the classification
- Conclusions:
- It is not possible to categorize the test item Pyrolytic Sugar as corrosive or not with the performance described in this study
- Executive summary:
The study was conducted to determine the skin corrosion potential of Pyrolytic Sugar in the Reconstructed Human Epidermis (RHE). The study was conducted following the OECD Guideline 431 and EU Method B.40-BIS. One valid experiment with additional tests was performed. As the test item showed intense coloring in the pre-test, there was the risk to influence the photometric measurement and a false negative result. Therefore, an additional test for intensely coloured test items was performed. But the result of the additional test showed, that the test item colour did not critically influence the result of the study. In the pre-test the test item showed MTT-reducing properties. The probability to influence the photometric measurement and of a false negative result had to be excluded. Therefore, an additional test using freeze-killed tissues was performed. The result of the additional test showed that MTT reduction by the test item did influence the measurement and a correction of the result of the main test was necessary.
In the main test two tissues of the human skin model EpiDermTM were treated with the test itemfor 3 minutes and 1 hour, the, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a blue formazan. Formazan production was evaluated by measuring the optical density (OD) of the resulting solution. After 3 minutes treatment with the test item, the mean value of relative tissue viability was reduced to 93.5% in the main test and 16.5% after correction. After 1 hour treatment, the mean value of relative tissue viability was reduced to 72.8% in the main test and 6.6% after correction. As the correction was greater than 30% of the negative control value (77% in the 3 min. exp. and 66.2% in the 1 hour exp.), it is not possible to obtain a reliable result without performing further tests to consider whether it is tissue damage and therefore corrosive properties or MTT reduction by the test item itself.
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