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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:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 9.10.2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid
- Details on test material:
- Test material was sublimed for purification.
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The test method uses isolated corneas from the eyes of freshly slaughtered cattle.
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL test item suspension (tested as a suspension with a concentration of 20% in Hank’s Balanced Salt Solution (HBSS); 10-fold concentrated, which was previously diluted in demin. water (1:10)
- Duration of treatment / exposure:
- Exposure time of corneas was 4 hours.
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- Incubation for 90 minutes at 32 ±1 °C in a horizontal position
- Number of animals or in vitro replicates:
- Three replicates per treatment group (negative control, test item and positive control)
- Details on study design:
- This in vitro study was performed to assess the corneal damage potential of AM(pfa)4 by quantitative measurements of changes in opacity and permeability in a bovine cornea. The BCOP test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability. Both measurements are used to calculate an “In Vitro Irritancy Score (IVIS)”, which is used to classify the test item in the UN Globally Harmonised System (GHS).
The BCOP test method uses isolated corneas from the eyes of freshly slaughtered cattle. The test item is applied to the epithelial surface of the cornea by addition to the anterior chamber of the corneal holder. Corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea, as detected in the medium in the posterior chamber.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Negative controls (HBSS)
- Value:
- -0.14
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test item (AM(pfa)4)
- Value:
- 24.94
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Positive control (20% imidazole solution)
- Value:
- 105.12
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Opacity and Permeability Values
The illuminance (unit: LUX) values which were measured before and after exposure are given in the following table:
Illuminance Values
Parameter | Negative Control | Test Item | Positive Control | ||||||
1. Rep. | 2. Rep. | 3. Rep. | 1. Rep. | 2. Rep. | 3. Rep. | 1. Rep. | 2. Rep. | 3. Rep. | |
Measured values [I] | 1025 | 1006 | 1009 | 1028 | 1014 | 1015 | 1004 | 1007 | 999 |
Measured values [I] | 1024 | 1010 | 1023 | 587 | 690 | 669 | 349 | 337 | 346 |
Rep. = Replicate
The values in the following tables present the calculated opacity values, according to evaluation scheme:
Opacity Values Negative Control
Parameter | Negative Control | ||
1. Rep. | 2. Rep. | 3. Rep. | |
Opacity before exposure | 3.10 | 3.90 | 3.77 |
Opacity after exposure | 3.14 | 3.73 | 3.18 |
Opacity Difference | 0.04 | -0.17 | -0.59 |
Mean Opacity Difference | -0.24 |
Rep. = Replicate
Opacity Values Test Item and Positive Control
Parameter | Test Item | Positive Control | ||||
1. Rep. | 2. Rep. | 3. Rep. | 1. Rep. | 2. Rep. | 3. Rep. | |
Opacity before exposure | 2.98 | 3.56 | 3.52 | 3.99 | 3.86 | 4.21 |
Opacity after exposure | 34.83 | 23.74 | 25.72 | 85.46 | 89.90 | 86.54 |
Opacity Difference | 31.85 | 20.18 | 22.21 | 81.47 | 86.04 | 82.33 |
Opacity Difference corrected | 32.09 | 20.42 | 22.45 | 81.71 | 86.28 | 82.57 |
Mean Opacity Difference corrected | 24.99 | 83.52 |
Rep. = Replicate
For the permeability measurement, three replicates for each treatment group were measured three times. cMEM without phenol red was measured as blank value as well. The optical density values at 492 nm are given in the following tables:
Optical density at 492 nm of Blank
Parameter | cMEM without phenol red |
1. Measurement | 0.038 |
2. Measurement | 0.037 |
3. Measurement | 0.034 |
Mean | 0.036 |
Optical density at 492 nm of Negative Control, Test Item and Positive Control
Parameter | Negative Control | Test Item | Positive Control | ||||||
1. Rep. | 2. Rep. | 3. Rep. | 1. Rep. | 2. Rep. | 3. Rep. | 1. Rep. | 2. Rep. | 3. Rep. | |
1.Mesurement | 0.043 | 0.041 | 0.045 | 0.040 | 0.042 | 0.037 | 1.485 | 1.040 | 1.967 |
2.Measurement | 0.043 | 0.042 | 0.044 | 0.041 | 0.041 | 0.038 | 1.474 | 1.033 | 1.930 |
3.Measurement | 0.043 | 0.043 | 0.044 | 0.040 | 0.042 | 0.038 | 1.471 | 1.027 | 1.919 |
1.Measurement – blank | 0.0067 | 0.0047 | 0.0087 | 0.0037 | 0.0057 | 0.0007 | 1.4487 | 1.0037 | 1.9307 |
2.Measurement – blank | 0.0067 | 0.0057 | 0.0077 | 0.0047 | 0.0047 | 0.0017 | 1.4377 | 0.9967 | 1.8937 |
3.Measurement – blank | 0.0067 | 0.0067 | 0.0077 | 0.0037 | 0.0057 | 0.0017 | 1.4347 | 0.9907 | 1.8827 |
Mean of each replicate | 0.0067 | 0.0057 | 0.0080 | 0.0040 | 0.0053 | 0.0013 | 1.4403 | 0.9970 | 1.9023 |
Mean of the | 0.0068 | -- | -- | ||||||
Corrected | -- | -- | -- | -0.0028 | -0.0014 | -0.0054 | 1.4336 | 0.9902 | 1.8956 |
Corrected mean of the 3 replicates | -- | -0.0032 | 1.4398 |
Rep. = Replicate
IVIS Values
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Test Group | IVIS | Mean IVIS | Relative Standard Deviation IVIS |
Negative Control HBSS | 0.14 | -0.14 | 223.23% |
-0.09 | |||
-0.47 | |||
Test Item LiAl(pftb)4 | 32.05 | 24.94 | 25.00% |
20.40 | |||
22.37 | |||
Positive Control 20% imidazole solution | 103.21 | 105.12 | 4.95% |
101.14 | |||
111.01 |
Note: the high relative standard deviation of the IVIS of the negative control is due to mathematical reasons, as the respective means are very small.
Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The mean IVIS of the negative control has to show an IVIS ≤3.
The validity criteria and findings are given in the following table:
Validity
Parameter | Criterion | Found | Assessment |
Mean IVIS of negative control HBSS | ≤ 3 | -0.14 | ok |
Mean IVIS of positive control 20% imidazole solution | 75.90 – 144.68 | 105.12 | ok |
All relevant values for negative and positive control were within the range of historical data of the test facility. Therefore, the test system was acceptable.
Assessment
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category with the BCOP test only. In this case no prediction can be made.
Classification Scheme
IVIS | UN GHS |
≤ 3 | No category |
> 3 and ≤ 55 | No prediction can be made |
> 55 | Eye damage Category I |
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
The test item AM(pfa)4 showed effects on the cornea of the bovine eye. The calculated mean IVIS (In Vitro Irritancy Score) was 24.94. The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item.
Applicant's summary and conclusion
- Interpretation of results:
- other: study shows that substance has effects to eyes but is not considered eye damaging.
- Conclusions:
- According to the outcome of this study the substance AM(pfa)4 is not considered as severe eye damaging, but showed effects on the cornea of the bovine eye.
- Executive summary:
This in vitro study was performed to assess corneal damage potential of AM(pfa)4 by quantitative measurements of changes in opacity and permeability in a bovine cornea. As test system bovine corneas were used derived from slaughtered cattle that were between 12 and 60 months old. The test item AM(pfa)4 was diluted to a concentration of 20% in HBSS. The suspension was applied onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ±1 °C for 1 hour and whose opacity had been measured. The test item was incubated on the cornea for 4 hours at 32 ±1 °C. After removal of the test item, opacity and permeability values were measured.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irritancy Score) was -0.14. 20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated mean IVIS was 105.12.
Under the conditions of this study, the test item AM(pfa)4 showed effects on the cornea of the bovine eye. The calculated mean IVIS was 24.94.
According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage with the BCOP study only. In this case no prediction can be made. However, the substance is not considered as severe eye damaging according to the results in this study.
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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