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EC number: 610-472-5 | CAS number: 49707-23-5
- 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
- Study period:
- 2009-11-02 to 2010-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed study according to OECD Technical Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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)
- Version / remarks:
- 440/2008/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate attached to the report.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- EC Number:
- 610-472-5
- Cas Number:
- 49707-23-5
- Molecular formula:
- C7 H13 N1 O3
- IUPAC Name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- Details on test material:
- - Sponsor's identification: NAAADA
- Batch no: 700090909
- Supplier Code: PH-09/0196
- Form: liquid
- Storage: +6°C
- Expiry date: 09 January 2010
Constituent 1
Method
- Target gene:
- TA 98: His D3052, TA 100: His G46, E.coli: Trp, TA 1535: His G46, TA 1537: His C3076
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from Aroclor induced rats
- Test concentrations with justification for top dose:
- 5µL, 1.67µL, 0.56µL, 0.19µL, 0.06µL
- Vehicle / solvent:
- - Solvent: water
- Maximum known solubility in the solvent: not provided
- Homogeneity in the solven: not provided
- Assay conditions: room temperature
- Stability under assay conditions: stable at 37°C during 24hrs
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- w/o S9, solvent DMSO Migrated to IUCLID6: TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- w/o S9, solvent water Migrated to IUCLID6: TA 100, TA 1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- w/o S9, solvent DMSO Migrated to IUCLID6: E. coli WP2
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- w/o S9, solvent DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9, all strains, solvent DMSO
- Details on test system and experimental conditions:
- Please see "Any other information on material and methods incl. tables"
- Evaluation criteria:
- The number of colonies per plate was counted with an automatic colony counter. Data are presented in tables as the number of colonies present per plate (mean +/- standard deviation).
A result will be considered positive, when R>2.5
The ration R is calculated as follows:
R = Number of revertant colonies in presence of the test item / Number of revertant colonies in absence of the test item
Several criteria are used for determining a positive result: a dose-response in the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system.
Historical negative (solvent/vehicle) and positive control values are represented in the attached document.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- - Sterility test showrd no contamination during the study
- No cytotoxic effect was observed
- The controls (positive and negative) were in concordance with the expected results
- Positive and negative controls showed absolute numbers of revertant colonies comparable to historical data
- No concentration of the test item showed a biological significant increase of the number of revertant either with or w/o S9 metabolic activation
- No dose-response was observed in none of the tested bacterial strains - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The results of the mutagenicity test are included in the attached documents.
The controls of the test were in concordance with the expected results:
− Sterility test showed no contamination during the study.
− No cytotoxic effect was observed.
− All positive controls performed showed valid ratios (R) above 2.5.
− Positive and negative controls showed absolute numbers of revertant colonies comparable to historical data.
− No concentration of the test item showed a biological significant increase (R ≥ 2.5) of the number of revertant either with or without S9 metabolic activation.
− No dose response was observed in none of the tested bacterial strains.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The following conclusions can be inferred from the obtained results:
− No experiment with the test item showed ratios (R) above 2.5 as compared to the negative control, either with or without S9 metabolic activation.
− No dose response was observed in none of the tested bacterial strains.
Based on the results obtained in this study, the test item NAAADA was found to be NON
MUTAGENIC and NON PRO-MUTAGENIC under the test conditions. - Executive summary:
The present bacterial reverse mutation test (Ames test) was performed in order to evaluate the mutagenic potential of the test item. The test was performed in accordance with OECD Guideline 471 for the Testing of Chemicals (Bacterial Reverse Mutation Test. Adopted 21st July 1997) and the test Method B13/B14 of Commission Directive 2000/32/EC. Doses ranging from 5μL to 0.06μL per plate were tested. No cytotoxicity was observed at any dose. Suspensions of 4 amino-acid requiring strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537) and one Escherichia coli WP2 strain (pKM 101) auxotroph for an amino acid were exposed by the direct plate incorporation method to five doses of the test item in the presence and in the absence of an exogenous metabolic activation system. Both tests were repeated with the pre-incubation method. Revertant bacteria due to point or frameshift-mutations at specific locus are able to grow, forming colonies. These colonies were counted and compared to the number of spontaneous revertant colonies on solvent control plate (negative control). Similarly, specific standard mutagens were tested and used as positive controls. Based on the results obtained in this study, the test item NAAADA was found to be NON MUTAGENIC and NON-PROMUTAGENIC under the test conditions.
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