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EC number: 202-500-6 | CAS number: 96-33-3
- 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:
- weight of evidence
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl acrylate
- EC Number:
- 202-500-6
- EC Name:
- Methyl acrylate
- Cas Number:
- 96-33-3
- Molecular formula:
- C4H6O2
- IUPAC Name:
- methyl prop-2-enoate
Constituent 1
- Specific details on test material used for the study:
- Identity : Methyl acrylate
Provided by : Basic Acrylic Monomer Manufacturers, Inc. (BAMM)
Date Received : 18 Oct 2017
Storage : Room temperature and humidity
Description : Clear colorless liquid
Sample Preparation : The test article was used as received.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test System:
Bovine eyes (at least six months old) were obtained from an abattoir and transported to the laboratory in a refrigerated container containing Hanks’ Balanced Salt Solution (HBSS) with penicillin-streptomycin. The bovine eyes were transported to MB Research on 02 Nov 2017, within 24 hours of harvest.
Pretest Procedures:
Fresh assay solutions were prepared prior to use. MEM solution was prepared by stirring together one jar (9.3 g) of MEM powder (sufficient to make one liter of solution), 2.2 g of sodium bicarbonate, 0.292 g L-glutamine, 10 ml of fetal bovine serum (FBS) and brought to a final volume of 1000 ml with distilled water. The MEM solution was kept in a 32 (±1)°C incubator for the duration of testing. HBSS was prepared by stirring together HBSS powder (sufficient to make one liter) and 0.35 g of sodium bicarbonate and brought to a final volume of 1000 ml with distilled water. HBSS was maintained at room temperature. In addition, MEM solution with phenol red was prepared by stirring together 9.3 g of MEM with phenol red (sufficient to make one liter), 2.2 g of sodium bicarbonate, 0.292 g L-glutamine, 10 ml of fetal bovine serum (FBS) and brought to a final volume of 1000 ml with distilled water. The MEM solution with phenol red was kept in a 32 (±1)°C incubator for the duration of testing.
The eyes will be examined after receipt from the abattoir. Any eye with a cornea exhibiting evidence of neovascularization, pigmentation, opacity or scratches will be discarded.
Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The corneas were then placed in a container of fresh HBSS.
The dissected corneas were mounted in specially designed holders (MC2, formerly Electro-Design – the manufacturer of the Op-KIT opacitometer) that were separated into anterior and posterior chambers and
filled separately. Each cornea was mounted allowing the epithelium of the cornea to project into the anterior chamber. The posterior chamber was filled with MEM solution ensuring contact with the endothelium. The anterior chamber was filled with MEM solution, ensuring contact with the epithelium. Each cornea was visually inspected again to ensure there were no defects.
Prior to collection of the pretest opacity scores, the OP-KIT opacitometer (Electro-Design Corporation, RIOM, France) was calibrated. The calibrator (an empty corneal holder designed to hold the calibrators)
was placed into the calibration chamber of the opacitometer. The opacitometer was first calibrated to zero opacity units by measuring the opacity without a calibrator (i.e., a polyester filter insert provided with
the OP-KIT). Then the opacitometer is calibrated to 75 opacity units using calibrator filter 1. During the test, if the opacity scores exceed 75, the opacitometer is recalibrated in the same manner, using the other
calibrators provided with the OP-KIT equipment (i.e., calibrator filter 2 or 3 that represent opacity of 150 and 225, respectively). A pre-exposure determination of opacity was made for each cornea by measuring
each against the blank supplied by the opacitometer. Fresh MEM was added before taking these baseline opacity readings. Any cornea with a value greater than 7 units was discarded.
The entire holder was incubated at 32 (±1)°C and allowed to equilibrate for at least one hour, but not longer than two hours.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- A volume of 0.75 ml of test article, ethanol, or MEM solution was applied to the epithelium of each of the three test article corneas, three positive control corneas and three negative control corneas in a manner which ensured that the entire cornea was covered. All corneas were dosed via the closed-chamber method.
- Duration of treatment / exposure:
- 10-minute exposure
- Duration of post- treatment incubation (in vitro):
- All holders and corneas were placed in a horizontal position (anterior chamber facing upward) in the 32 (±1)°C water-jacketed incubator (VWR, model: 1815 TC). After 10 (±1) minutes), the test article, ethanol, or MEM was removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. A final rinse was made with MEM without phenol red.
The anterior and posterior chambers of the holders were then refilled with fresh MEM solution. Opacity measurements were made following the 10-minute exposure and MEM solution refill.
All corneas were incubated at 32 (±1)°C for an additional two hours at which time the MEM solution in the anterior and posterior chambers was removed and the holders refilled with fresh MEM solution. A measurement of opacity was taken with each treated cornea compared to the blank supplied with the OP-KIT. This reading was used in the final IVIS calculations.
Immediately following the two-hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution in Dulbecco's phosphatebuffered saline (PBS). Each holder was then returned to the 32 (±1)°C incubator in a horizontal position (anterior chamber facing upward) ensuring contact of the fluorescein with the cornea. - Details on study design:
- Study Procedure:
Following the pretest observations, the MEM solution was removed from the anterior chamber. A volume of 0.75 ml of test article, ethanol, or MEM solution was applied to the epithelium of each of the three test
article corneas, three positive control corneas and three negative control corneas in a manner which ensured that the entire cornea was covered. All corneas were dosed via the closed-chamber method.
All holders and corneas were placed in a horizontal position (anterior chamber facing upward) in the 32 (±1)°C water-jacketed incubator (VWR, model: 1815 TC). After 10 (±1) minutes), the test article, ethanol, or MEM was removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. A final rinse was made with MEM without phenol red. The anterior and posterior chambers of the holders were then refilled with fresh MEM solution. Opacity measurements were made following the 10-minute exposure and MEM solution refill.
All corneas were incubated at 32 (±1)°C for an additional two hours at which time the MEM solution in the anterior and posterior chambers was removed and the holders refilled with fresh MEM solution. A
measurement of opacity was taken with each treated cornea compared to the blank supplied with the OP-KIT. This reading was used in the final IVIS calculations.
Immediately following the two-hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution in Dulbecco's phosphatebuffered
saline (PBS). Each holder was then returned to the 32 (±1)°C incubator in a horizontal position (anterior chamber facing upward) ensuring contact of the fluorescein with the cornea.
The Spectronic 20-D Colorimeter Spectrophotometer (Milton/Roy, model: 333175) was calibrated prior to use on the same day of dosing. Calibration entailed first adjusting the wavelength to 490nm and the transmittance to 0.0%. The transmittance for a sample of fresh distilled water (in a cuvette, inserted into the sample compartment) was adjusted to 100.0% on the spectrophotometer. The mode was then switched to absborance before collecting optical density study data. After 90 (±5) minutes, the fluid from the posterior chamber of each corneal holder was removed and the amount of dye that passed through
the cornea (permeability) was measured as the optical density at 490nm (i.e., the OD490nm) by a spectrophotometry.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 12.55
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The assay was accepted because the positive control had an IVIS that fell within two standard deviations of the historical mean.
Any other information on results incl. tables
RESULTS:
TEST ARTICLE: Methyl acrylate
Cornea ID |
Pretest Opacity Score |
10-Minute Opacity Score |
2-Hour Opacity Score |
Corrected Opacity Scores1 |
OD490 nm (Permeability) |
Corrected Optical Density2 |
|
10-Minute |
2-Hour |
||||||
7 |
5 |
9 |
7 |
4 |
2 |
0.880 |
0.864 |
8 |
5 |
6 |
13 |
1 |
8 |
0.164 |
0.148 |
9 |
5 |
7 |
12 |
2 |
7 |
0.845 |
0.829 |
Corrected Mean Optical Density3= |
0.614 |
||||||
2-Hour Corrected Mean Opacity Score4= |
3.34 |
1Individual Corrected Opacity Score: 10-minute or 2-hour opacity score minus pretest opacity score
2Individual Corrected Optical Density: Individual test article OD minus the mean OD for the negative control group
3Corrected Mean Optical Density: Mean of the individual corrected optical density values for a given dose group
42-Hour Corrected Mean Opacity Score: Mean of the individual 2-hour corrected opacity scores for a given dose group minus the mean opacity score for the negative control group
NEGATIVE CONTROL: MEM
Cornea ID |
Pretest Opacity Score |
10-Minute Opacity Score |
2-Hour Opacity Score |
Corrected Opacity Scores1 |
OD490 nm (Permeability) |
||
10-Minute |
2-Hour |
||||||
1 |
4 |
2 |
5 |
-2 |
1 |
0.015 |
|
2 |
3 |
2 |
7 |
-1 |
4 |
0.016 |
|
3 |
3 |
2 |
5 |
-1 |
2 |
0.017 |
|
Mean of Individual Optical Density = |
0.016 |
||||||
2-Hour Corrected Mean Opacity Score4= |
2.33 |
||||||
POSITIVE CONTROL: Ethanol
Cornea ID |
Pretest Opacity Score |
10-Minute Opacity Score |
2-Hour Opacity Score |
Corrected Opacity Scores1 |
OD490 nm (Permeability) |
Corrected Optical Density2 |
|
10-Minute |
2-Hour |
||||||
4 |
1 |
27 |
28 |
26 |
27 |
0.305 |
0.289 |
5 |
3 |
28 |
27 |
25 |
24 |
0.845 |
0.829 |
6 |
3 |
35 |
33 |
32 |
30 |
0.598 |
0.582 |
Corrected Mean Optical Density3= |
0.567 |
||||||
2-Hour Corrected Mean Opacity Score4= |
24.67 |
1Individual Corrected Opacity Score:10 minute or 2-hour opacity score minus pretest opacity score
2Individual Corrected Optical Density:Individual positive control OD minus the mean OD for the negative control group
3Corrected Mean Optical Density:Mean of the individual corrected optical density values for a given dose group
42-Hour Corrected Mean Opacity Score:Mean of the individual 2-hour corrected opacity scores for a given dose group minus the mean opacity score for the negative control group; no correction was made for the negative control
CALCULATED IN VITRO IRRITANCY SCORES
Test Article |
Negative Control |
Positive Control |
Methyl acrylate |
MEM |
100% Ethanol |
3.34 + (15 x 0.614) |
2.33 + (15 x 0.016) |
24.67 + (15 x 0.567) |
3.34 + 9.21 |
2.33 + 0.24 |
24.67 + 8.505 |
IVIS = 12.55 |
IVIS = 2.57 |
IVIS = 33.18 |
Positive Control Historical Data |
|
Mean IVIS |
26.98 |
Standard Deviation |
5.01 |
n |
63 |
The ethanol positive control IVIS was 33.18, which fell within the acceptance range of 16.96 - 37.00
(± 2 standard deviations of the historical mean).
Applicant's summary and conclusion
- Interpretation of results:
- other: The results from this study support the weight of evidence that Methyl Acrylate is not corrosive.
- Conclusions:
- The objective of the study was to determine the potential for ocular irritation using an alternative to the Draize methodology. This protocol is based on the methodology described in the current OECD Guideline for the Testing of Chemicals No. 437. Three bovine corneas per group were dosed with 0.75 ml of Methyl acrylate, Minimal Essential Media (MEM, negative control), or 100% ethanol (EtOH)) (positive control). Following a 10-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined. Results of the study indicate that the IVIS score for Methyl Acrylate is 12.55.
- Executive summary:
The objective of the study was to determine the potential for ocular irritation using an alternative to the Draize methodology. This protocol is based on the methodology described in the current OECD Guideline for the Testing of Chemicals No. 437. Three bovine corneas per group were dosed with 0.75 ml of Methyl acrylate, Minimal Essential Media (MEM, negative control), or 100% ethanol (EtOH)) (positive control). Following a 10-minute exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined. Results of the study indicate that the IVIS score for Methyl Acrylate is 12.55.
Summary
Treatment
In VitroIrritancy
Score (IVIS)
Corrected Mean
Opacity Score
Corrected Mean Optical
Density
Methyl acrylate
12.55
3.34
0.614
100% EtOH
(Positive Control)
33.18
24.67
0.567
Treatment
In VitroIrritancy Score
(IVIS)
Corrected Mean
Opacity Score
Mean Optical Density
MEM
(Negative Control)
2.57
2.33
0.016
Conclusions
Test Article ID
In VitroIrritancy
Score (IVIS)
UN GHS Categorization
EURL ECVAM
DB-ALM Protocol 127
Classification
Methyl acrylate
12.55
No Prediction Can Be
Made
Mild Eye Irritant
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