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EC number: 203-750-9 | CAS number: 110-26-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 19 to August 30, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC method B.51: Skin Sensitisation, Local Lymph Node Assay: BrdU-ELISA, Commission Regulations (EU) No. 640/2012, adopted July 06, 2012.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N'-methylenediacrylamide
- EC Number:
- 203-750-9
- EC Name:
- N,N'-methylenediacrylamide
- Cas Number:
- 110-26-9
- Molecular formula:
- C7H10N2O2
- IUPAC Name:
- N,N'-methylenediacrylamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): N,N‘-Methylenediacrylamide
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: LQ27A1677
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: No data on stability were available to LPT.
- Storage condition of test material: No data on stability were available.
- Other: No 'Certificate of Analysis' was available .
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:JN
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: JANVIER LABS.
Route des Chènes Secs C.S.4105
Le Genest-Saint-Isle
53941 Saint Berthevin Cedex
France
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 20 - 27 g
- Housing: Before application the animals were housed in groups of 5 animals in MAKROLON cages (type III) with a basal surface of approx. 39 cm x 23 cm and a height of approx. 15 cm. After application the animals were housed singly in order to prevent them licking off the test item from the ears of the other animals.
- Diet (e.g. ad libitum): ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH).This food was offered ad libitum.
- Water (e.g. ad libitum): Tap water was offered ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature of 22°C ± 3°C (maximum range)
- Humidity (%): relative humidity of 55% ± 15% (maximum range)
- Air changes (per hr): 15 to 20 times per hr
- Photoperiod (hrs dark / hrs light): The rooms were alternately lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.
IN-LIFE DATES: From: To: First administration August 25, 2016; Termination of the experimental phase August 30, 2016
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10% (w/w)
25% (w/w)
50% (w/w) - No. of animals per dose:
- 30 (6 groups of 5 animals each)
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: 50% in N,N-dimethylformamide (w/w)
- Irritation: none
- Lymph node proliferation response: none
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LOCAL LYMPH NODE ASSAY: BRDU-ELISA
- Criteria used to consider a positive response: An index for the lymph node cell count ≥ 1.6 is considered positive.
TREATMENT PREPARATION AND ADMINISTRATION:
An index for the lymph node cell count ≥ 1.6 is considered positive.
The test item formulations were administered to the dorsum of both animal's ears at an application volume of 25 µL/ear. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- As no concentration-related increased values were observed, no statistical evaluation was carried out. Comparison of positive control to its negative control was carried out using Student’s t-test.
Results and discussion
- Positive control results:
- Treatment with the positive control item caused the expected increases in the BrdU labelling index. Therefore, the study can be regarded as valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.837
- Test group / Remarks:
- Group 2 (10%) / BrdU labelling index
- Key result
- Parameter:
- SI
- Value:
- 1.019
- Test group / Remarks:
- Group 2 (10%) / Ear weight
- Key result
- Parameter:
- SI
- Value:
- 1.038
- Test group / Remarks:
- Group 2 (10%) / Difference of ear thickness (TD 3)
- Key result
- Parameter:
- SI
- Value:
- 1.052
- Test group / Remarks:
- Group 2 (10%) / Difference of ear thickness (TD 6)
- Key result
- Parameter:
- SI
- Value:
- 0.771
- Test group / Remarks:
- Group 3 (25%) / BrdU labelling index
- Key result
- Parameter:
- SI
- Value:
- 1.081
- Test group / Remarks:
- Group 3 (25%) / Ear weight
- Key result
- Parameter:
- SI
- Value:
- 1.043
- Test group / Remarks:
- Group 3 (25%) / Difference of ear thickness (TD 3)
- Key result
- Parameter:
- SI
- Value:
- 1.033
- Test group / Remarks:
- Group 3 (25%) / Difference of ear thickness (TD 6)
- Key result
- Parameter:
- SI
- Value:
- 0.743
- Test group / Remarks:
- Group 4 (50%) / BrdU labelling index
- Key result
- Parameter:
- SI
- Value:
- 1.063
- Test group / Remarks:
- Group 4 (50%) / Ear weight
- Key result
- Parameter:
- SI
- Value:
- 1.071
- Test group / Remarks:
- Group 4 (50%) / Difference of ear thickness (TD 3)
- Key result
- Parameter:
- SI
- Value:
- 1.038
- Test group / Remarks:
- Group 4 (50%) / Difference of ear thickness (TD 6)
Any other information on results incl. tables
Study results: stimulation indices (SI):
Parameter |
Group 1, negative control |
Group 2, test item 10% |
Group 3, test item 25% |
Group 4, test item 50% |
Group 5, positive control |
Group 6, positive control |
BrdU labelling index |
1.000 |
0.837 |
0.771 |
0.743 |
1.778 |
1.000 |
Ear weight |
1.000 |
1.019 |
1.081 |
1.063 |
1.228 |
1.000 |
Difference of ear thickness (TD 3) |
1.000 |
1.038 |
1.043 |
1.071 |
1.078 |
1.000 |
Difference of ear thickness (TD 6) |
1.000 |
1.052 |
1.033 |
1.038 |
1.128 |
1.000 |
____ increases significantly compared to control at p ≤ 0.01
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, N,N‘-Methylenediacrylamide did not reveal any skin sensitising properties in the local lymph node assay: BrdU-ELISA.
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