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EC number: 612-154-1 | CAS number: 6147-66-6
- 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
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- bis(prop-2-en-1-yl)amine hydrochloride
- EC Number:
- 612-154-1
- Cas Number:
- 6147-66-6
- Molecular formula:
- C6H11N.HCl
- IUPAC Name:
- bis(prop-2-en-1-yl)amine hydrochloride
- Test material form:
- liquid
- Remarks:
- Salt dissolved in water
Constituent 1
- Specific details on test material used for the study:
- 66% purity
Aqueous solution
Method
- Target gene:
- Histidine (S. typhimurium) and Tryptophan (E. coli).
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:
- Type and composition of metabolic activation system:
- source of S9 : Sprague Dawley Rat Liver
- method of preparation of S9 mix : prepared from rats pre-treated with a mixture known to induce an elevated level of these enzymes
- Volume of S9 mix in the final culture medium: 0.5 mL of S9-mix was added to the molten, trace amino-acid supplemented media instead of phosphate buffer
- quality controls of S9 sterility: A 0.5 mL aliquot of S9-mix and 2 mL of molten, trace histidine or tryptophan supplemented, top agar were overlaid onto a sterile Vogel-Bonner Minimal agar plate in order to assess the sterility of the S9-mix. This procedure was repeated, in triplicate, on the day of each experiment.
S9 enzymatic activity was validated. - Test concentrations with justification for top dose:
- Experiment 1 (using the direct plate incorporation method): 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate
Experiment 2 (using the pre-incubation method): 15, 50, 150, 500, 1500 and 5000 μg/plate, determined by the results of Experiment 1 - Vehicle / solvent:
- - Vehicle used: sterile distilled water
- Justification for choice of vehicle: The test item was supplied ‘neat’ at a maximum concentration of 660 mg/mL, therefore it was diluted in sterile distilled water to achieve a maximum recommended concentration of 50 mg/mL (equivalent to the test guideline maximum recommended dose level (5000 μg/plate) when plated out). Sterile distilled water was therefore selected as the vehicle.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- The test item was supplied ‘neat’ at a maximum concentration of 660 mg/mL, therefore it was diluted in sterile distilled water to achieve a maximum recommended concentration of 50 mg/mL (equivalent to the test guideline maximum recommended dose level (5000 μg/plate) when plated out). Sterile distilled water was therefore selected as the vehicle.
The test item was accurately measured and, on the day of each experiment, approximate half-log dilutions prepared in sterile distilled water. All test item preparation and dosing was performed under yellow safety lighting.
All formulations were used within four hours of preparation and were assumed to be stable for this period. Analysis for concentration, homogeneity and stability of the test item formulations is not a requirement of the test guidelines and was, therefore, not determined. This is an exception with regard to GLP and has been reflected in the GLP compliance statement. - Rationale for test conditions:
- The maximum concentration was 5000 μg/plate (the OECD TG 471 maximum recommended dose level). Eight concentrations of the test item (1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method
- Evaluation criteria:
- 1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. A fold increase greater than two times the concurrent solvent control for TA100, TA98 and WP2uvrA or a three-fold increase for TA1535 and TA1537 (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).
5. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989). - Statistics:
- Statistical significance was confirmed by using Dunnett’s Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Experiment 1 (plate incorporation) – Table 2 and Table 3 (see attachement in background material)
The maximum dose level of the test item in the first experiment was selected as the OECD TG 471 recommended dose level of 5000 μg/plate. There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix). No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of metabolic activation (S9-mix).
There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix).
Experiment 2 (pre-incubation) – Table 4 and Table 5 (see attachement in background material)
The maximum dose level of the test item in the second experiment was the same as for Experiment 1 (5000 μg/plate). Toxicity, evaluated as a visible reduction in the growth of the bacterial background lawns and/or a reduction in revertant counts, was observed with test item exposure to all tester strains dosed in the absence of exogenous metabolic activation (S9-mix) from 1500 μg/plate. There was however, no visible reduction in the growth of the bacterial background lawn at any dose level, in the presence of exogenous metabolic activation (S9-mix). No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of metabolic activation (S9-mix). There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix).
Applicant's summary and conclusion
- Conclusions:
- The test item is considered to be non-mutagenic under the conditions of the test, for both methods, with and without metabolic activation.
- Executive summary:
The in vitro genotoxicity in bacteria of the test substance 2-propen-1-amine, N-2-propen-1-yl, hydrochloride was determined during a Reverse Mutation Assay ‘Ames Test’ using strains of Salmonella typhimurium and Escherichia coli according to the OECD TG 471. The Ames preincubation method was performed both with and without the addition of a rat liver homogenate metabolizing system (S9 -mix). Sensitivity of the assay and the efficacy of the S9-mix were validated by positive, negative and vehicle controls. The dose range was determined during a preliminary toxicity assay and ranged between 1.5 and 5000 μg/plate. As a result of this experiment, 5000 μg/plate was
selected as the highest dose to be tested during the main experiment performed according to the preincubation
method
The test item 2-propen-1-amine, N-2-propen-1-yl, hydrochloride did not induce an increase in the frequency of revertant colonies that met the criteria for a positive result, either with or without metabolic activation. Under the conditions of this test 2-propen-1-amine, N-2-propen-1-yl, hydrochloride was considered to be non-mutagenic.
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