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EC number: 219-102-3 | CAS number: 2359-15-1
- 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:
- 2017-03-14 to 2017-03-22
- 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 guidelineopen allclose all
- 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:
- adopted July 26, 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- December 09, 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N'-methylenebis[methacrylamide]
- EC Number:
- 219-102-3
- EC Name:
- N,N'-methylenebis[methacrylamide]
- Cas Number:
- 2359-15-1
- Molecular formula:
- C9H14N2O2
- IUPAC Name:
- N,N'-methylenebis(2-methylacrylamide)
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- The test item was suspended in a 0.9 % sodium chloride solution with a final concentration of 20n% (w/v).
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not applicable
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
- Concentration: 20 % (w/v)
VEHICLE
- Amount applied: 750 µL
- Concentration: 0.9 %
- Lot/batch no.: Batch no. 163548002; B. Braun Melsungen AG, 34212 Melsungen, Germany - Duration of treatment / exposure:
- 240 min
- Number of animals or in vitro replicates:
- 3 corneas each
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS, QUALITY CHECK OF THE ISOLATED CORNEAS: For a detailed description please see section “any other information on materials and methods incl. tables”.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: yes, 0.9 % sodium chloride solution (identical to solvent control).
POSITIVE CONTROL USED: yes, 20 % Imidazole in 0.9 % sodium chloride solution
APPLICATION DOSE AND EXPOSURE TIME: 750 µL of a 20 % (w/v) solution; 240 min
TREATMENT METHOD: open chamber
REMOVAL OF TEST SUBSTANCE: for a detailed description please see section “any other information on materials and methods incl. tables”.
- Number of washing steps after exposure period: at least three times.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (OD490)
- For a detailed description please see section “any other information on materials and methods incl. tables”.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: for a detailed description please see section “any other information on materials and methods incl. tables”.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test item
- Value:
- ca. -1.078
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for solvent control: yes. The IVIS of the solvent control was 0.076.
- Acceptance criteria met for positive control: yes. The IVIS of the positive control was 79.071.
Any other information on results incl. tables
RESULTS
Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was 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. The measurements were used to calculate an in vitro irritancy score (IVIS), which was used to assign an in vitro irritancy hazard classification category for prediction of the in vivo ocular irritation potential of the test item.
Three corneas were used for each treatment group (test item, negative control and positive control). The corneas treated with the negative control item 0.9 % sodium chloride solution revealed a mean opacity value of -0.079 ± 0.890 and a mean permeability value of 0.010 ± 0.001. The calculated IVIS value of 0.076 ± 0.884 was well below the cut-off value of 3 (UN GHS no category).
The corneas treated with the positive control item 20 % Imidazole in 0.9 % NaCl solution revealed a mean opacity value of 59.176 ± 12.740 and a mean permeability value of 1.326 ± 0.107 compared to the solvent control. The calculated IVIS value of 79.071± 14.007 was within two standard deviations of the current historical mean and well above the cut-off value of 55. Hence, the acceptance criteria for the test were fulfilled.
Following treatment with the test item, a mean opacity of -1.183 ± 0.709 and a mean permeability value of 0.007 ± 0.004 compared to the negative control were determined. The calculated IVIS of -1.078 ± 0.773 is below the cut-off value of 3 (UN GHS no category). Hence, the test item did not show severely irritant or corrosive properties and consequently it is not classified as a severe irritant and is not corrosive according to UN GHS classification.
The opacity and permeability values are given in Tables 1 and 2. The IVIS values are given in Table 3.
Table 1: Opacity values
|
Cornea No. |
Opacity [opacity units] |
Corrected opacity |
||
|
|
|
|
Mean of group |
Standard deviation |
0.9 % NaCl |
1 |
0.917 |
-0.079 |
-0.079 |
0.890 |
2 |
-0.797 |
||||
3 |
-0.358 |
||||
20 % Imidazole |
4 |
73.505 |
73.584 |
59.176 |
12.740 |
5 |
49.323 |
49.402 |
|||
6 |
54.463 |
54.542 |
|||
Test item (20 % w/v) |
7 |
-0.637 |
-0.558 |
-1.183 |
0.709 |
8 |
-1.116 |
-1.037 |
|||
9 |
-2.032 |
-1.953 |
Table 2: Permeability OD Values (490 nm)
|
Cornea No. |
Permeability [OD], mean of triplicates |
Corrected permeability per cornea |
Standard deviation per cornea |
Corrected permeability per group (mean) |
Standard deviation per group |
0.9 % NaCl |
1 |
0.010 |
0.010 |
0.002 |
0.010 |
0.001 |
2 |
0.011 |
0.011 |
0.001 |
|||
3 |
0.010 |
0.010 |
0.002 |
|||
20 % Imidazole |
4 |
1.413 |
1.403 |
0.032 |
1.326 |
0.107 |
5 |
1.214 |
1.204 |
0.020 |
|||
6 |
1.382 |
1.372 |
0.006 |
|||
Test item (20 % w/v) |
7 |
0.020 |
0.010 |
0.001 |
0.007 |
0.004 |
8 |
0.019 |
0.009 |
0.003 |
|||
9 |
0.012 |
0.002 |
0.002 |
Table 3: In vitro irritancy score (IVIS)
|
Cornea No. |
Opacity |
Permeability |
IVIS |
||
|
|
|
|
Per cornea |
Per group |
|
|
|
|
|
Mean |
SD |
|
0.9 % NaCl |
1 |
0.917 |
0.010 |
1.067 |
0.076 |
0.884 |
2 |
-0.797 |
0.011 |
-0.632 |
|||
3 |
-0.358 |
0.010 |
-0.208 |
|||
20 % Imidazole |
4 |
73.584 |
1.403 |
94.629 |
79.071 |
14.007 |
5 |
49.402 |
1.204 |
67.462 |
|||
6 |
54.542 |
1.372 |
75.122 |
|||
Test item (20 % w/v) |
7 |
-0.558 |
0.010 |
-0.408 |
-1.078 |
0.773 |
8 |
-1.037 |
0.009 |
-0.902 |
|||
9 |
-1.953 |
0.002 |
-1.923 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions, the test substance tested in the in vitro BCOP test method, had an IVIS value of -1.078 ± 0.773, which is below the cut-off value of 3 (EU GHS no category). The test item is neither classified as a severe irritant nor as corrosive according to EU GHS classification. Therefore, GHS criteria are not met.
- Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of N,N´-methylenebis[methacrylamide] by means of the BCOP assay using fresh bovine corneae according to OECD guideline 437, adopted July 2013 and EU method B.47, December 2010.
The corneae were incubated with the test substance and controls for 240 min. The test was performed in triplicates. Opacity and permeability were determined. The in vitro irritancy score (IVIS) was calculated as mean opacity value + (15 x mean OD490 value. A substance that induces an IVIS ≥ 55 is defined as a corrosive or severe irritant while a substance that induces an IVIS ≤ 3 refers to EU GHS “no category”.
The corneas treated with the negative control item 0.9 % sodium chloride solution revealed a calculated IVIS value of 0.076 ± 0.884 which was well below the cut-off value of 3 (EU GHS no category).
N,N´-methylenebis[methacrylamide] caused no increase of the corneal opacity and permeability. Under the present test conditions, N,N´-methylenebis[methacrylamide] had an IVIS value of -1.078 ± 0.773, which is below the cut-off value of 3 (EU GHS no category).
The corneas treated with the positive control item 20 % Imidazole revealed a calculated IVIS value of 79.071 ± 14.007. This was within two standard deviations of the current historical mean and well above the cut-off value of 55. Hence, the acceptance criteria for the test were fulfilled.
Under the present test conditions, N,N´-methylenebis[methacrylamide] it is not classified as a severe irritant and is not corrosive according to EU GHS classification.
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