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EC number: 203-640-0 | CAS number: 109-02-4
- 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:
- 1990-06-25 - 1990-06-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methylmorpholine
- EC Number:
- 203-640-0
- EC Name:
- 4-methylmorpholine
- Cas Number:
- 109-02-4
- Molecular formula:
- C5H11NO
- IUPAC Name:
- 4-methylmorpholine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 6398-24-20
- Lot No.: Project #90-005
- Substance type: Clear colorless liquid
- Physical state: Liquid
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in the physical state of the test article during the assay.
- Storage condition of test material: For the purposes of this study, the test article was stored at room temperature in the container received from the sponsor.
Method
- Target gene:
- histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: uvrB deletion mutation and a rfa mutation
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: uvrB deletion mutation and a rfa mutation
- Metabolic activation:
- with and without
- Metabolic activation system:
- aroclor 1254-induced male Sprague-Dawley rat liver homogenate
- Test concentrations with justification for top dose:
- preliminary toxicity prescreen: 50, 167, 500, 1670 and 5000 ug/plate in absence of S9
mutation assay: 167, 500, 1670, 5000, 7500 and 10000 ug/plate in the presence and absence of S9 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- solvent or test substance without tester strains
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- in the absence of metabolic activation 10.0 ug/plate for TA1535 and TA100
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- solvent or test substance without tester strains
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- in the absence of metabolic activation 150 ug/plate for TA1537
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- solvent or test substance without tester strains
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- in the absence of metabolic activation 5.00 ug/plate for TA1538 and TA98
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- solvent or test substance without tester strains
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine, 2.50 ug/plate for all 5 tester strains
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicate - Evaluation criteria:
- A positive result is defined as a statistically significant, dose-dependent increase in the number of histidine-independent revertants with at least one dose level inducing a revertant frequency that is two-fold the spontaneous solvent control value. If the test article does not induce a statistically significant, dose-dependent increase in revertant frequency but does induce a revertant frequency at one dose level that is two-fold the spontaneous control value, the results is considered equivocal. A negative result is defined as the absence of a statistical significant or dose-dependent increase in the number of histidine-independent revertants.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- evaluated in toxicity prescreen by treating duplicate cultures of strain TA100 in absence of S9; the substance was not toxic up to 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- evaluated in toxicity prescreen by treating duplicate cultures of strain TA1538 in absence of S9; the substance was not toxic up to 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test substance demonstrated to be negative in the Ames/Salmonella Plate Incorporation Assay under the conditions of the test, and according to the criteria of the protocol. The substance is considered not to be classified as mutagenic according to the CLP Regulation.
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