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EC number: 946-533-0 | CAS number: -
- 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:
- 2015-07-16 to 2015-07-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ß-Alanine, N-(2-aminoethyl)-N-(2-hydroxyethyl)-, N-(C12-C18 and C18unsatd. acyl) derivs., monosodium salts
- Cas Number:
- 93820-52-1
- Molecular formula:
- C12 fatty acid based: C19H37N2NaO4 - C18 fatty acids based: C23H45N2NaO4
- IUPAC Name:
- ß-Alanine, N-(2-aminoethyl)-N-(2-hydroxyethyl)-, N-(C12-C18 and C18unsatd. acyl) derivs., monosodium salts
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Aqueous solution of beta-Alanine, N-(2-aminoethyl)-N-(2-hydroxyethyl)-, N-cocoacyl derivs., monosodium salts
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
- Details on mammalian cell type (if applicable):
- Regular checking of the properties of the Salmonella typhimurium and Escherichia coli strains regarding the membrane permeability, ampicillin resistance; UV sensitivity, and amino acid requirement as well as normal spontaneous mutation rates is performed
- Additional strain / cell type characteristics:
- other: Salmonella strains: rfa-, uvrB-; E. coli strain: uvrA-
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 Mix
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment II: 0.3, 1, 3, 10, 33, 100, 333, 1000 and 2500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: solubility properties and relative nontoxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (without metabolic activation); 2-aminoanthracene (with metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:plate incorporation (experiment I) and preincubation (experiment II)
DURATION
- Preincubation period: 60 min (only experiment II)
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): all Salmonella typhimurium strains: histidine; E. coli strain: tryptophane
NUMBER OF REPLICATES: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants; reduction of the bacterial background lawn - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment.
However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- not mandatory
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:
- cytotoxicity
- 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: To evaluate the toxicity of the test item a pre-experiment was performed with all strains used. Eight concentrations were tested for toxicity and mutation induction with each 3 plates. The pre-experiment is reported as main experiment I, since the following criteria are met: Evaluable plates (>0 colonies) at five concentrations or more in all strains used.
COMPARISON WITH HISTORICAL CONTROL DATA: In experiment I the number of colonies did not quite reach the lower limit of the laboratory's historical control data in the negative control of strain TA 1535 with metabolic activation. Since this deviation is rather small, this effect is judged to be based upon statistical fluctuations and has no detrimental impact on the outcome of the study.
Any other information on results incl. tables
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed reduced background growth at the following concentrations (µg/plate):
Strain |
Experiment I |
Experiment II |
||
|
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
TA 1535 |
1000-5000 |
1000-5000 |
1000-2500 |
2500 |
TA 1537 |
1000-5000 |
1000-5000 |
333-2500 |
1000-2500 |
TA 98 |
1000-5000 |
1000-5000 |
333-2500 |
1000-2500 |
TA 100 |
333-5000 |
333-5000 |
333-2500 |
1000-2500 |
WP2 uvrA |
1000-5000 |
1000-5000 |
2500 |
2500 |
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain |
Experiment I |
Experiment II |
||
|
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
TA 1535 |
1000-5000 |
2500-5000 |
1000-2500 |
2500 |
TA 1537 |
1000-5000 |
2500-5000 |
1000-2500 |
2500 |
TA 98 |
1000-5000 |
1000-5000 |
333-2500 |
1000-2500 |
TA 100 |
33; 333-5000 |
333-5000 |
33-2500 |
333-2500 |
WP2 uvrA |
2500-5000 |
2500-5000 |
2500 |
2500 |
Applicant's summary and conclusion
- Conclusions:
- During the described mutagenicity test and under the experimental conditions reported, no substantial increase in revertant colony numbers of any of the five tester strains was observed at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Therefore, Amphopropionate C12-18 is considered to be non-mutagenic in this Salmonella typhimurium and 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 (2008) 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 C12 -18 (ca. 40% a.i.) at concentrations of 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate using the plate incorporation method and at concentrations of 0.3, 1, 3, 10, 33, 100, 333, 1000 and 2500 µg/plate using the reincubation method both in the absence and presence of mammalian metabolic activation.
The positive controls induced the appropriate responses in the corresponding strains and metabolic activation was confirmed. Precipitation of Amphopropionate C12 -18 did not occur up to the highest investigated dose. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains with and without metabolic activation.
In both mutation assays, no increase in the number of revertants over background was observed upon treatment with Amphopropinate C12 -18 under all conditions tested.
Based on the results of this study it is concluded that Amphopropionate C12 -18 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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