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EC number: 213-086-1 | CAS number: 923-02-4
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline-study OECD 471. Not in full compliance with GLP but according top good scientific practice and laboratory involved was subject to regular GLP inspections at the time of performance. Study according to relevant guideline.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 994
- Reference Type:
- other: SCF (scientific Committee on Food)
- Title:
- Unnamed
- Year:
- 1 999
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The bacterial reverse mutation test is able to identify substances that cause point mutations, by substitution, addition or deletion of one or a few
DNA base-pairs. Mutagenic substances can induce reversion in histidine-(for Salmonella typhimurium) or tryptophan-(for Escherichia coli)
deficient strains which are then able to grow and form colonies in a histidine- or tryptophan limited medium, while non-reverted strains cannot. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(hydroxymethyl)methacrylamide
- EC Number:
- 213-086-1
- EC Name:
- N-(hydroxymethyl)methacrylamide
- Cas Number:
- 923-02-4
- Molecular formula:
- C5H9NO2
- IUPAC Name:
- N-(hydroxymethyl)-2-methylacrylamide
- Details on test material:
- - Name of test material (as cited in study report): N-Methylolmethacrylamide 15 % aqueous solution
- Substance type: organic
- Physical state at room temperature: liquid
- Storage condition of test material: 4 to 6 °C
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix fraction of Aroclor 1254-induced rat livers
- Test concentrations with justification for top dose:
- 0, 100, 500, 2500, 5000 and 7500 µg/plate (all 4 strains), and at 2500, 5000, 7500 and 10.000 µg/plate (TA 100 only)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: The solvent was chosen because of its relative nontoxicity for the bacteria.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive controls:
- yes
- Remarks:
- for TA 1537
- Positive control substance:
- other: 9-aminoacridine chloride monohydrate, without S9-mix
- Remarks:
- 9-aminoacridine chloride monohydrate (purity: no data, supplier: no data) dissolved in DMSO; concentration: 100 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive controls:
- yes
- Remarks:
- TA 98
- Positive control substance:
- other: 4-nitro-o-phenylendiamine, without metabolic activation
- Remarks:
- 4-nitro-o-phenylenediamine (purity: no data, supplier: no data) dissolved in DMSO; concentration: 10 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive controls:
- yes
- Remarks:
- for TA 1535, TA 100
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), without metabolic activation
- Remarks:
- N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) (purity: no data, supplier: no data ) dissolved in DMSO; concentration: 5 µg/plate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dissolved in DMSO
- Positive controls:
- yes
- Remarks:
- for TA 1535, TA 1537, TA 98, TA 100
- Positive control substance:
- other: 2-aminoanthracene, with metabolic activation
- Remarks:
- 2-aminoanthracene (purity: no data, supplier: no data ) dissolved in DMSO; concentration: 10 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- solvent control, sterility control
- Remarks:
- +/- S9 mix; determination of spontaneous mutation rate
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS: 3 test plates per dose or control standard plate test and preincubation test with and without S9-mix
- Evaluation criteria:
- A test article is considered positive if either a dose related and reproducible increase in the number of revertants or a significant and reproducible
increase for at least one test concentration is induced.
A test article producing neither a dose related and reproducible increase in the number of revertants nor a significant and reproducible positive
response at any one of the test points is considered non-mutagenic in this system.
A significant response is described as follows:
A test article is considered mutagenic if the number of reversions is at least twice as high (control) in one of the tester strains. It exists a dose-response relationship and the results are reproducible.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- other: weakly positive when reevaluated by SCF negative
- Additional information on results:
- A weakly bacteriotoxic effect was observed only in the preincubation assay at doses greater 5000 µg/plate without S-9 mix using TA 1537 and TA 98.
- Remarks on result:
- other: other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results:
In the standard plate test, no induction of point mutations by
N-Methylolmethacrylamide could be detected in any of the 4 stains, with or
without S9-mix, although none were tested up to the cytotoxic dose range. In the
preincubation test. There was no evidence of mutagenic activity in stains
TA98, TA1535 and TA1537, with and without S9-mix. A week bacteriotoxic effect
was seen only in strains TA98 and TA1537 at >= 5000 µg/plate without S9-mix.
Strain TA 100 showed weak mutagenic activity in the preincubation test at
5000 - 10000 µg/plate in the presence of S9-mix. At 5000 µg/plate the number of
his+ revertants increased by a factor of 1.4 - 1.6, and at 10000 µg/plate by a factor of 1.9. In the absence of S9-mix, in one of the two
experiments with TA100, there was a slight but not dose-dependent increase (by a
factor of 1.4 - 1.7) in the number of his+ revertants at 2500 - 10000 µg/plate.
The inverstigators concluded that 15 % aqueous N-Methylolmethacrylamide is
weakly mutagenic in the Ames test but a reevaluation of the SCF (Scientific Committee on Food) classified the substance under the above mentioned conditions as negative in the Ames test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The inverstigators concluded that 15 % aqueous N-Methylolmethacrylamide is weakly mutagenic in the Ames test in one of the four strains (TA 100) tested. A reevaluation of the SCF (Scientific Committee on Food) classified the substance under the above mentioned conditions as negative in the Ames test according to OECD guideline 471. - Executive summary:
In a reverse gene mutation assay in bacteria (Ames test), strains TA1535, TA1537, TA98, TA100 of Salmonella typhimurium were exposed to N-Methylolmethacrylamide 15 % aqueous solution at concentrations of up to 7500 µg/plate in the presence and absence of mammalian metabolic activation S9 -mix all tester stains and up to 10000 µg/plate tester stain TA 100.
In the standard plate test, no induction of point mutations by N-Methylolmethacrylamide could be detected in any of the 4 stains,
with or without S9-mix, although none were tested up to the cytotoxic dose range. In the preincubation test. There was no evidence of mutagenic activity in stains TA98, TA1535 and TA1537, with and without S9-mix. A week bacteriotoxic
effect was seen only in strains TA98 and TA1537 at >= 5000 µg/plate without S9-mix. Strain TA 100 showed weak mutagenic
activity in the preincubation test at 5000 - 10000 µg/plate in the presence of S9-mix. At 5000 µg/plate the number of his+ revertants increased by a factor of 1.4 - 1.6, and at 10000 µg/plate by a factor of 1.9. In the absence of S9-mix, in one of the two experiments with TA100, there was a slight but not
dose-dependent increase (by a factor of 1.4 - 1.7) in the number of his+ revertants at 2500 - 10000 µg/plate.
Appropriate reference mutagens were used as positive controls.
The positive controls induced the appropriate responses in the corresponding strains.
This study is classified as acceptable. This study satisfies the requirement for tests for in vitro mutagenicity (bacterial reverse gene mutation) data.
Conclusion:
Under the conditions of this study according to OECD 471, the test substance, N-Methylolmethacrylamide 15 % aqueous solution showed a weak mutagenic activity in only one on the tester strains TA100 in the bacterial reverse mutation test with Salmonella typhimurium. A reevaluation of the SCF (Scientific Committee on Food) classified the substance under the above mentioned conditions as negative in the Ames test according to OECD guideline 471.
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