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Reaction mass of 2-{[(2-{3-[2-({[2-(methacryloyloxy)ethoxy]carbonyl}amino)propan-2-yl]phenyl}propan-2-yl)carbamoyl]oxy}propyl methacrylate and 1,3-phenylenebis(propane-2,2-diylcarbamoyloxyethane-2,1-diyl) bis(2-methylacrylate) and 1,3-phenylenebis(propane-2,2-diylcarbamoyloxypropane-2,1-diyl) bis(2-methylacrylate)
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- Sept., 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX, UK, protocol no. 98 "The Bovine Corneal Opacity and Permeability Assay", dated February 994
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 1,3-phenylenebis(propane-2,2-diylcarbamoyloxyethane-2,1-diyl) bis(2-methylacrylate) and 2-{[(2-{3-[2-({[2-(methacryloyloxy)ethoxy]carbonyl}amino)propan-2-yl]phenyl}propan-2-yl)carbamoyl]oxy}propyl methacrylate and 1,3-phenylenebis(propane-2,2-diylcarbamoyloxypropane-2,1-diyl) bis(2-methylacrylate)
- Molecular formula:
- C26H36N2O8, C27H38N2O8, C28H40N2O8
- IUPAC Name:
- Reaction mass of 1,3-phenylenebis(propane-2,2-diylcarbamoyloxyethane-2,1-diyl) bis(2-methylacrylate) and 2-{[(2-{3-[2-({[2-(methacryloyloxy)ethoxy]carbonyl}amino)propan-2-yl]phenyl}propan-2-yl)carbamoyl]oxy}propyl methacrylate and 1,3-phenylenebis(propane-2,2-diylcarbamoyloxypropane-2,1-diyl) bis(2-methylacrylate)
Constituent 1
Test animals / tissue source
- Species:
- other: test system: freshly isolated bovine cornea
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Rationale: Recommended by INVITTOX, UK, protocol no. 98
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 0.9% (w/v) NaCl in deionised water (saline; negative control), 2-Ethoxyethanol (positive control)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL - Duration of treatment / exposure:
- 10 min
- Observation period (in vivo):
- Third opacity reading (t130) done 2h after 2nd opacity measurement (t10). The optical density was measured after additional 90 min.
- Number of animals or in vitro replicates:
- 3 replicate corneas for each treatment group (negative control solution, test item and positive control)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): test item or control items, respectively, were rinsed off from the application side with saline
- Time after start of exposure: 10 min
SCORING SYSTEM: This test is designed to measure the opacity of the cornea by quantifying the ability of light to pass through it. The permeability, as a result of the irritation potential of the test item, is determined using Na-fluorescein solution. The comparison of the opacity before and after the exposure to the test item and the determination of the permeability after the treatment provide an indication of the irritant effect of the test item.
TOOL USED TO ASSESS SCORE: For the measurement of the corneae opacity the OP_KiT opacitometer (Electro Design, 63-Riom France) was used. Permeability of the cornea possibly caused by the test item, was determined with 1 mL of a Na-fluorescein solution, 0.5 % (w/v) dissolved in HBSS (Hank’s buffered salt solution). The optical density was measured spectrophotometrically at 490 nm (OD490).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea #1 and #2 (test item)
- Value:
- 0.33
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: corrected value; IVIS ≤ 3 -> No Category (UN GHS, Eye damage)
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea #3 (test item)
- Value:
- 1.33
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: corrected value; IVIS ≤ 3 -> No Category (UN GHS, Eye damage)
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean (test item)
- Value:
- 0.79
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: IVIS ≤ 3 -> No Category (UN GHS, Eye damage)
- Other effects / acceptance of results:
- With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro score was calculated as 0.47.
The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as severe eye irritant. The mean in vitro score was calculated as 70.31.
Any other information on results incl. tables
Results after 10 Minutes Incubation Time
Test Group | Opacity value = Difference (t130 -t0) of Opacity | Permeability at 490 nm (OD490) | IVIS | Proposed in vitro irritation scale | ||||
Mean | Mean | Mean | ||||||
Negative Control | 0 | -0.33 | 0.054 | 0.054 | 0.81 | 0.47 | Non eye irritant | |
-1 | 0.052 | -0.22 | ||||||
0 | 0.055 | 0.83 | ||||||
Positive Control | 53.33* | 0.740* | 64.44 | 70.31 | Severe eye irritant | |||
52.33* | 0.802* | 64.37 | ||||||
73.33* | 0.585* | 82.11 | ||||||
Test Item | 0.33* | 0.015* | 0.56 | 0.79 | Not corrosive / irritant(CLP/GHS) | |||
0.33* | 0.001* | 0.35 | ||||||
1.33* | 0.008* | 1.46 |
*corrected values
The validity criteria and findings are given in the following table:
Parameter | Criterion | Found | Assessment |
IVIS of negative control | ≤ 3 | 0.47 | valid |
IVIS of positive control | 59.17 - 108.11 | 70.31 | valid |
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study and under the experimental conditions reported, according to the CLP/GHS classification the test item is not considered to be corrosive/irritant to the eye. 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. This single in vitro test can serve as a stand-alone test as it was consistently shown that the test item does not require classification (eye damage).
- Executive summary:
This in vitro GLP study according to OECD Guideline 437 was performed to assess the corneal irritation and damage potential of the test substance by means of the BCOP assay using fresh bovine corneae.
After a first opacity measurement of the fresh bovine corneae (t0), the neat test item, the positive, and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1% fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t10). Further, the corneae were incubated for another 120 minutes at 32 ± 1 °C in complete medium, and opacity was measured a third time (t130).
After the opacity measurements permeability of the corneae was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 1 °C in a horizontal position. The liquid coming out was measured spectrophotometrically.
With the negative control (0.9% (w/v) NaCl solution in deionised water) neither an increase of opacity nor permeability of the corneae could be observed.
The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as severe eye irritant.
The test item did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was 0.79.
In conclusion, it can be stated that in this study and under the experimental conditions reported, according to the CLP/GHS classification the test item is not considered to be corrosive/irritant to the eye.
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