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EC number: 203-867-5 | CAS number: 111-41-1
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No Escherichia coli or S. typhimurium TA102 included
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(2-aminoethylamino)ethanol
- EC Number:
- 203-867-5
- EC Name:
- 2-(2-aminoethylamino)ethanol
- Cas Number:
- 111-41-1
- Molecular formula:
- C4H12N2O
- IUPAC Name:
- 2-[(2-aminoethyl)amino]ethan-1-ol
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- - S.typhimurium: Histidine gene
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:
- Type and composition of metabolic activation system:
- source of S9 : male Sprague-Dawley rats (200 - 300 g) received a single intraperitoneal injection of 500 mg Aroclor 1254 (as a 20% solution in peanut oil - w/v) per kg body weight.
- method of preparation of S9 mix : The S-9 mix is prepared freshly prior to each experiment. For this purpose, a sufficient amount of S-9 fraction is thawed at room temperature and 3 volumes of S-9 fraction are mixed with 7 volumes of S-9 supplement (cofactors). - Test concentrations with justification for top dose:
- Experiment 1: (Standard plate test with and without S-9 mix Strains: TA1535, TA 100 . TA 1537, TA 98)
Doses: 20, 100, 500, 2500 and 5000 μg/plate
Experiment 2: (Standard plate test with and without S-9 mix Strains: TA1535, TA100, TA1537, TA98)
Doses: 2000, 4000, 6000 and 8000 μg/plate
Number of plates: 3 test plates per dose or control.
Experiment 3: (preincubation test with and without S-9 mix. Strains: TA1535, TA100, TA1537, TA98)
Doses: 20, 100, 500, 2500, 5000 μg/plate
Experiment 4: (preincubation test with and without S-9 mix. Strains: TA1535)
Doses: 20, 100, 500, 2500, 5000 μg/plate - Vehicle / solvent:
- - Vehicle/solvent used: No solvent was used, the test substance was competely dissolved in aqua dest
.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S-9: 5 μg N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) (dissolved in DMSO ) for the strains TA 100 and TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- without S-9: 10 μg 4-nitro-o-phenylendiamine (dissolved in DMSO) for the strain TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S-9: 100 μg 9-aminoacridine chloride monohydrate (dissolved in DMSO) for the strain TA 1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S-9: 2-aminoanthracene (dissolved in DMSO) for the strains TA 100, TA 98, TA 1537 and TA 1535
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: two standard plate tests and two preincubation tests
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding: a germ density of ≥ 10*E8 bacteria/mL
- Test substance added in agar (plate incorporation)
TREATMENT (Experiment 1 and 2, standard plate test)
- Preincubation period: no preincubation
- Exposure duration: 48 hours in the dark
- Exposure temperature: 37°C
TREATMENT (Experiment 3 and 4, preincubation test)
- Preincubation period: 20 minutes preincubation at 37°C
- Exposure duration: 48 hours in the dark
- Exposure temperature: 37 °C
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: The reduction of the bacterial background growth, and decreasse in the number of his+ revertants. - Evaluation criteria:
- Evaluation criteria
In general, a substance to be characterized as positive in the Ames test has to fulfill the following
requirements:
- doubling of the spontaneous mutation rate ( compared to the control)
- dose-response relationship
- reproducibility of the results - Statistics:
- No statistical analysis was performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- only in the preincubated test reduced his- growth at doses ≥2500 µg/plate.
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- only in the preincubated test reduced his- growth at doses ≥5000 µg/plate.
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- only in the preincubated test reduced his- growth at doses ≥2500 µg/plate.
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- only in the preincubated test reduced his- growth at doses ≥5000 µg/plate.
- Additional information on results:
- Ames test:
- Signs of toxicity : A bacteriotoxic effect (reduced his background growth, decrease in the number of his+ revertants) was observed only in the preincubation test depending on the strain at doses > 2500 µg/plate.
- Individual plate counts: See attached files
- Mean number of revertant colonies per plate and standard deviation:See attached files
Applicant's summary and conclusion
- Conclusions:
- An Ames study was performed with TA 1535, TA1537, TA98 and TA100 following OECD guideline 471, and showed that the test substance Aminoethylethanolamin is not mutagenic in the Ames test under the experimental conditions used.
- Executive summary:
An in vitro gene mutation (AMES) test was perfored similar to OECD 471 guideline with strains TA 1535, TA1537, TA98 and TA 100. All bacteria strains showed negative response up to 8000 ug/plate in the standard plate test and up to 5000 ug/plate in the preincubated test, i.e. no significant dose-related increase in the number of revertants with or without metabolic activation was obeserved. Toxicity was observed only in the preincubation test depending on the strain at doses ≥ 2500 ug/plate.
Based on the results of this study it is concluded that Aminoethylethanolamin is not mutagenic in the Salmonella typhimurium reverse mutation assay with or without metabolic activation.
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