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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:
- 13-20 April 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Unknown
- Cas Number:
- Unknown
- IUPAC Name:
- Unknown
- Reference substance name:
- Calcium oxide
- EC Number:
- 215-138-9
- EC Name:
- Calcium oxide
- Cas Number:
- 1305-78-8
- Molecular formula:
- CaO
- IUPAC Name:
- oxocalcium
- Reference substance name:
- Quartz (SiO2)
- EC Number:
- 238-878-4
- EC Name:
- Quartz (SiO2)
- Cas Number:
- 14808-60-7
- Molecular formula:
- SiO2
- IUPAC Name:
- Quartz
- Reference substance name:
- Zinc sulphide
- EC Number:
- 215-251-3
- EC Name:
- Zinc sulphide
- Cas Number:
- 1314-98-3
- Molecular formula:
- SZn
- IUPAC Name:
- thioxozinc
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- Silicon dioxide
- Reference substance name:
- Carbon
- EC Number:
- 231-153-3
- EC Name:
- Carbon
- Cas Number:
- 7440-44-0
- Molecular formula:
- C
- IUPAC Name:
- Carbon
- Test material form:
- solid: nanoform
- Remarks:
- Fine black powder
- Details on test material:
- - State of aggregation:
spherical particles clustered together to form loose aggregates in organic media.
- Particle size distribution:
median (d(50)) size of 27.51 nm at the major axis and 23.62 nm at the minor axis.
- Shape of particles:
Spheroid
- Surface area of particles:
136.368 m2 cm-3
- Coating:
none
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
Sponsor; Lot: 2021/3/17/1
- Purity, including information on contaminants, isomers, etc.:
UVCB
RADIOLABELLING INFORMATION (if applicable)
none
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature in a closed container
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Since no workable suspension of the test material in physiological saline could be obtained, the test material was used as delivered by the sponsor and added pure on top of the corneas.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 322.43 to 359.14 mg
VEHICLE
No vehicle - Duration of treatment / exposure:
- 240 +- 10 minutes
- Number of animals or in vitro replicates:
- triplicate
- Details on study design:
- NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: physiological saline
SOLVENT CONTROL USED (if applicable): none
POSITIVE CONTROL USED: 20% (w/v) Imidazole
APPLICATION DOSE AND EXPOSURE TIME: applied directly on the corneas in such a way that the cornea was completely covered (322.43 to 359.14 mg). Corneas were incubated in a horizontal position for 240 10 minutes at 32 +- 1 degrees C.
TREATMENT METHOD: cMEM filled chamber
POST-INCUBATION PERIOD: No
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: thrice
METHODS FOR MEASURED ENDPOINTS:
The opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance by a light meter. The change in opacity for each individual cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final post-treatment reading. The corrected opacity for each cornea treated with the test material or positive control was calculated by subtracting the average change in opacity of the negative control corneas from the change in opacity of each test material or positive control treated cornea. The mean opacity value of each treatment group was calculated by averaging the corrected opacity values of the treated corneas for each treatment group.
Following the final opacity measurement, permeability of the cornea to Na-fluorescein (Sigma-Aldrich, Germany) was evaluated. After the incubation period, the medium in the posterior compartment of each holder was removed and placed into a sampling tube labelled according to holder number. 360 L of the medium from each sampling tube was transferred to a 96-well plate. The optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader (TECAN Infinite® M200 Pro Plate Reader). Any OD490 that was 1.500 or higher was diluted to bring the OD490 into the acceptable range (linearity up to OD490 of 1.500 was verified before the start of the experiment). OD490 values of less than 1.500 were used in the permeability calculation.
The mean OD490 for each treatment was calculated using cMEM corrected OD490 values. If a dilution has been performed, the OD490 of each reading of the positive control and the test material was corrected for the mean negative control OD490 before the dilution factor was applied to the reading.
SCORING SYSTEM:
In Vitro Irritancy Score (IVIS)
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- >= 0.2 - <= 3.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Mean in vitro irritancy score of 1.6 after 240 minutes of treatment.
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Table 1: Summary of Opacity, Permeability and In Vitro Scores
Treatment | Mean Opacity | Mean Permeability | Mean In vitro Irritation Score 1, 2 |
Negative control | 1.7 | -0.007 | 1.6 |
Positive control | 88 | 2.595 | 127 |
Test material | 1.2 | 0.023 | 1.6 |
1 Calculated using the negative control corrected mean opacity and mean permeability values for the positive control and test material.
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Table 2: Opacity Score
Treatment | Opacity before treatment | Opacity after treatment | Final Opacity1 | Negative control corrected Final Opacity 2 | Mean Final Opacity |
|
|
|
|
|
|
Negative control | 3.2 | 7.3 | 4.2 |
| 1.7 |
2.3 | 3.1 | 0.8 | |||
2.8 | 3.1 | 0.3 | |||
|
|
|
|
|
|
Positive control | 0.7 | 91 | 91 | 89 | 88 |
1.8 | 83 | 81 | 79 | ||
0.7 | 99 | 98 | 97 | ||
|
|
|
|
|
|
Test material | 0.3 | 2.0 | 1.6 | -0.1 | 1.2 |
1.2 | 5.9 | 4.7 | 3.0 | ||
0.8 | 3.3 | 2.5 | 0.8 |
Calculations are made without rounding off.
1 Final Opacity = Opacity after treatment – Opacity before treatment.
2 Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control
Table 3: Permeability Score Individual Values (Uncorrected)
Treatment | Dilution factor | OD490 | OD490 | OD490 | Average OD | Final OD | Mean final negative control |
1 | 2 | 3 | |||||
|
|
|
|
|
|
|
|
Negative control | 1 | -0.005 | -0.005 | -0.005 | -0.005 | -0.005 | -0.007 |
1 | -0.010 | -0.009 | -0.008 | -0.009 | -0.009 | ||
1 | -0.007 | -0.006 | -0.006 | -0.006 | -0.006 | ||
|
|
|
|
|
|
|
|
Positive control | 6 | 0.548 | 0.552 | 0.551 | 0.550 | 3.302 |
|
6 | 0.382 | 0.401 | 0.404 | 0.396 | 2.374 |
| |
6 | 0.349 | 0.348 | 0.358 | 0.352 | 2.110 |
| |
|
|
|
|
|
|
|
|
Test material | 1 | 0.021 | 0.018 | 0.019 | 0.019 | 0.019 |
|
1 | 0.015 | 0.018 | 0.015 | 0.016 | 0.016 |
| |
1 | 0.034 | 0.034 | 0.033 | 0.034 | 0.034 |
|
Calculations are made without rounding off.
Table 4: Permeability Score Individual Values (Corrected)
Treatment | Dilution factor | Negative control corrected OD490 11 | Negative control corrected OD490 21 | Negative control corrected OD490 31 | Negative control corrected OD490 Average | Negative control corrected final OD490 | Average OD |
|
|
|
|
|
|
|
|
Positive control | 6 | 0.548 | 0.552 | 0.551 | 0.550 | 3.302 | 2.595 |
6 | 0.382 | 0.401 | 0.404 | 0.396 | 2.374 | ||
6 | 0.349 | 0.348 | 0.358 | 0.352 | 2.110 | ||
|
|
|
|
|
|
|
|
Test material | 1 | 0.021 | 0.018 | 0.019 | 0.019 | 0.019 | 0.023 |
1 | 0.015 | 0.018 | 0.015 | 0.016 | 0.016 | ||
1 | 0.034 | 0.034 | 0.033 | 0.034 | 0.034 |
Calculations are made without rounding off.
1 Since the mean final OD490 value of the negative control is below zero, no correction was made.
Table 5: In Vitro Irritancy Score
Treatment | Final Opacity2 | Final OD490 | In vitro Irritancy Score 1 |
|
|
|
|
Negative control | 4.2 | -0.005 | 4.1 |
0.8 | -0.009 | 0.6 | |
0.3 | -0.006 | 0.2 | |
|
|
|
|
Positive control | 89 | 3.302 | 138 |
79 | 2.374 | 115 | |
97 | 2.110 | 128 | |
|
|
|
|
Test material | -0.1 | 0.019 | 0.2 |
3.0 | 0.016 | 3.2 | |
0.8 | 0.034 | 1.3 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490 value).
2 Positive control and test material are corrected for the negative control.
Table 6: Historical Control Data for the BCOP Studies
| Negative control | Positive control | ||
| Opacity | Permeability | In vitro Irritancy Score | In vitro Irritancy Score |
Min | -2.42 | -0.009 | -2.34 | 69 |
Max | 5.80 | 0.202 | 5.90 | 280 |
Mean | 1.00 | 0.012 | 1.18 | 147 |
SD | 1.60 | 0.019 | 1.61 | 32 |
n | 193 | 193 | 193 | 200 |
SD = Standard deviation
n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of February 2019 to February 2022.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, since Amorphous carbon and silicon dioxide recovered from two-stage pyrolysis of spent tyres induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
- Executive summary:
The objective of this study was to evaluate the eye hazard potential of Amorphous carbon and silicon dioxide recovered from two-stage pyrolysis of spent tyres as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test).
This report describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage potential of the test material was tested through topical application for approximately 240 minutes.
The study procedures described in this report were based on the most recent OECD guideline.
Batch 2021/3/17/1 of the test material was a fine black powder. Since no workable suspension in physiological saline could be obtained, the test material was used as delivered and added pure on top of the corneas.
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 127 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The test material did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.6 after 240 minutes of treatment.
In conclusion, since Amorphous carbon and silicon dioxide recovered from two-stage pyrolysis of spent tyres induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
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