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EC number: 264-761-2 | CAS number: 64265-45-8
- 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
- Study period:
- 2007-03-20 to 2007-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- June 8, 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine
- EC Number:
- 264-761-2
- EC Name:
- N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine
- Cas Number:
- 64265-45-8
- Molecular formula:
- C15H30N2O4
- IUPAC Name:
- N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
- Details on test material:
- - Analytical purity: 50.6%
- Physical state: liquid
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine locus (Salmonella typhimurium strains) and tryptophan locus (E. coli strain)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: additional rfa, gal, chl, bio and uvrB mutations in S. typhimurium strains and uvrA mutation in E.coli strain
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix
- Test concentrations with justification for top dose:
- Dose range finding test: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
First test: 3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate
Second test: 100, 333, 1000, 3330, 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: (without metabolic activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replicates, 2 independent repeats
DETERMINATION OF CYTOTOXICITY
- Method: reduction of the bacterial background lawn, increase in the size of the microcolonies, reduction of revertant colonies - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA 100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA 100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA 1535, TA 1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
b) In case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- No formal hypothesis testing was done.
Results and discussion
Test results
- Species / strain:
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- With the exception of tester strain TA 100 in the absence of S9-mix, where a moderate reduction of the revertant colonies compared to the solvent control was observed at the highest tested concentration.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES:
- Toxicity: No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed. With the exception of tester strain TA 100 in the absence of S9-mix, where a moderate reduction of the revertant colonies compared to the solvent control was observed at the highest tested concentration.
- Mutagenicity: In the dose range finding test, no increase in the number of revertants was observed upon treatment with the test substance under all conditions tested.
COMPARISON WITH HISTORICAL CONTROL DATA:
negative and strain-specific positive control values were within laboratory historical control data ranges
ADDITIONAL INFORMATION ON CYTOTOXICITY (DEFINITIVE TEST):
In tester strain TA 100 in the absence of S9-mix, a moderate reduction of the revertant colonies was observed at the highest tested concentration, however the reduction was not below the historical control data range. In the presence of S9-mix, fluctuations in the number of revertant colonies just below or around the laboratory historical control data range were observed. However, since no dose-relationship was observed, the reductions are not considered to be caused by toxicity of the test substance.
In all other tester strains both in the first and second mutation assay, there was no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in all tester strains in the absence and presence of S9-mix.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Amphopropionate C8 (50%) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (July, 1997) and EU Method B. 13/14 (June, 2000) strains of S. typhimurium (TA 1535, TA 1537, TA 98 and TA 100) and E. coli (WP2 uvr A) were exposed in two independent experiments to Amphopropionate C8 (50 %) at concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate (first test) and 100, 333, 1000, 3330, 5000 µg/plate (second test) in the absence and presence of mammalian metabolic activation using the plate incorporation method.
The positive controls induced the appropriate responses in the corresponding strains and metabolic activation was confirmed. Precipitation of the test item on the plates was not observed at the start or at the end of the incubation period in both tester strains.
In tester strain TA 100 in the absence of S9-mix, a moderate reduction of the revertant colonies was observed at the highest tested concentration, however the reduction was not below the historical control data range. In all other tester strains both in the first and second mutation assay, there was no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in all tester strains in the absence and presence of S9-mix.
In both mutation assays, no increase in the number of revertants over background was observed upon treatment with Amphopropinate C8 under all conditions tested.
Based on the results of this study it is concluded that Amphopropionate C8 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. This study is classified as acceptable. It satisfies the requirements for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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