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EC number: 221-698-5 | CAS number: 3195-78-6
- 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
- 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:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-methyl-N-vinylacetamide
- EC Number:
- 221-698-5
- EC Name:
- N-methyl-N-vinylacetamide
- Cas Number:
- 3195-78-6
- Molecular formula:
- C5H9NO
- IUPAC Name:
- N-ethenyl-N-methylacetamide
Constituent 1
- Specific details on test material used for the study:
- Batch no: 4043/97-17
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 20, 100, 500, 2500 and 5000 ug/plate (concentrations for Standard Plate Test and Preincubation Test)
- Vehicle / solvent:
- Due to the good solubility of the test substance in water, water was selected as the vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine and 4-nitroquinoline-N-oxide
- Remarks:
- Parallel with each experiment, negative controls are carried out in order to check for possible contaminants (sterility control) and to determine the spontaneous mutation rate (vehicle control).
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st Experiment: in agar (plate incorporation), 2nd Experiment: preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48-72 hours
NUMBER OF REPLICATIONS: 3 test plates per dose or per control in the 1st and 2nd experiment, each
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of background lawn (= reduced his- or trp- background growth), reduction in the titer
OTHER: Determination of solubility
As long as precipitation does not interfere with the colony scoring, 5 mg/plate is generally selected and analyzed (in cases of nontoxic compounds) as the maximum dose at least in the 1st experiment even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate might also be tested in repeat experiments for further clarification/substantiation. - Evaluation criteria:
- Acceptance criteria:
Generally, the experiment is to be considered valid if the following criteria are met:
- The number of revertant colonies in the negative controls was within the normal range of the historical control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control articles both with and withaut S-9 mix induced a significant inerease in the number of revertant colonies withinthe range of the historical control data.
- The titer of viable bacteria was >10E9/mL.
Evaluation criteria:
The test chemical is considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number~of revertant colonies, i.e. about daubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
- The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in twa experiments carried aut independently af each other.
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A slight decrease in the number of revertants was occasionally observed.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No precipitation of the test substance was found.
Any other information on results incl. tables
Standard plate test
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
||||
TA1535 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
|
Results without S9 |
|||||
Water |
18 ± 1 |
106 ± 5 |
9 ± 2 |
25 ± 1 |
25 ± 1 |
20 |
19 ± 2 |
116 ± 14 |
7 ± 2 |
22 ± 6 |
22 ± 2 |
100 |
15 ± 2 |
98 ± 2 |
7 ± 1 |
25 ± 2 |
25 ± 6 |
500 |
16 ± 0 |
83 ± 8 |
5 ± 1 |
27 ± 5 |
25 ± 3 |
2500 |
15 ± 3 |
81 ± 1 |
5 ± 1 |
21 ± 3 |
26 ± 3 |
5000 |
13 ± 3 |
92 ± 5 |
6 ± 1 |
22 ± 4 |
23 ± 3 |
MNNG (5.0) |
721 ± 26 |
755 ± 23 |
|||
AAC (100) |
771 ± 16 |
||||
NOPD (10) |
689 ± 70 |
||||
4-NQO (5) |
895 ± 58 |
||||
Results with S9 |
|||||
Water |
19 ± 1 |
141 ± 12 |
10 ± 2 |
38 ± 3 |
37 ± 2 |
20 |
16 ± 2 |
122 ± 7 |
11 ± 3 |
39 ± 3 |
28 ± 2 |
100 |
16 ± 2 |
145 ± 15 |
8 ± 1 |
31 ± 2 |
31 ± 3 |
500 |
15 ± 2 |
142 ± 23 |
6 ± 1 |
26 ± 4 |
26 ± 6 |
2500 |
10 ± 3 |
124 ± 5 |
7 ± 1 |
27 ± 5 |
25 ± 5 |
5000 |
8 ± 1 |
162 ± 14 |
7 ± 2 |
29 ± 4 |
22 ± 3 |
2-AA (2.5) |
223 ± 6 |
1460 ± 169 |
165 ± 11 |
914 ± 33 |
|
2-AA (60.0) |
223 ± 17 |
Pre incubation test
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
||||
TA1535 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
|
Results without S9 |
|||||
Water |
20 ± 2 |
131 ± 5 |
10 ± 2 |
27 ± 3 |
26 ± 3 |
20 |
18 ± 2 |
135 ± 11 |
11 ± 2 |
27 ± 2 |
24 ± 3 |
100 |
17 ± 2 |
120 ± 11 |
8 ± 1 |
23 ± 3 |
31 ± 4 |
500 |
18 ± 2 |
124 ± 4 |
6 ± 2 |
20 ± 3 |
23 ± 4 |
2500 |
15 ± 3 |
125 ± 5 |
6 ± 2 |
20 ± 3 |
23 ± 1 |
5000 |
16 ± 3 |
124 ± 9 |
6 ± 1 |
20 ± 2 |
22 ± 2 |
MNNG (5.0) |
1133 ± 235 |
1105 ± 32 |
|||
AAC (100) |
660 ± 35 |
||||
NOPD (10) |
989 ± 13 |
||||
4-NQO (5) |
802 ± 35 |
||||
Results with S9 |
|||||
Water |
21 ± 3 |
139 ± 14 |
12 ± 3 |
38 ± 1 |
36 ± 4 |
20 |
18 ± 2 |
133 ± 9 |
12 ± 5 |
39 ± 5 |
27 ± 3 |
100 |
18 ± 2 |
145 ± 9 |
9 ± 1 |
34 ± 3 |
29 ± 4 |
500 |
17 ± 1 |
145 ± 7 |
12 ± 1 |
34 ± 6 |
33 ± 1 |
2500 |
17 ± 2 |
148 ± 9 |
8 ± 3 |
34 ± 2 |
41 ± 2 |
5000 |
16 ± 3 |
139 ± 4 |
5 ± 1 |
27 ± 3 |
44 ± 5 |
2-AA (2.5) |
113 ± 14 |
681 ± 18 |
148 ± 12 |
870 ± 62 |
|
2-AA (60.0) |
182 ± 14 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.