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EC number: 204-590-2 | CAS number: 123-00-2
- 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:
- 5 June 1992 to 29 June 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Organisation for Economic Co-operation and Development Guidelines for Testing Chemicals ISBN 92-64-12221-4
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no strain tested for detecting certain mutagens, cross-linking agents and hydrazines (i.e. strains TA102 or WP2uvrA)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-morpholinopropylamine
- EC Number:
- 204-590-2
- EC Name:
- 3-morpholinopropylamine
- Cas Number:
- 123-00-2
- Molecular formula:
- C7H16N2O
- IUPAC Name:
- 3-morpholin-4-ylpropan-1-amine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not specified
- Expiration date of the lot/batch: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the clear glass container received from the sponsor;
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
Method
- Target gene:
- Histidine locus (Salmonella strains)
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 - induced rat liver S9
- Test concentrations with justification for top dose:
- Toxicity Pre-screen (TA1538 and TA100): 0, 50.0, 167, 500, 1670 and 5000 µg per plate with and without S9;
Mutation Assay (all strains): 0, 167, 500, 1670, 5000, 7500 and 10000 µg per plate with and without S9;
Retest (all strains): 16.7, 50.0, 167, 500, 1670 and 5000 µg per plate with 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:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without S9; 10.0 µg/plate for TA1535 and TA100
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9; 150 µg/plate for TA1537
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without S9; 5.00 µg/plate for TA1538 and TA98
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Remarks:
- With S9; 2.50 µg/plate for TA1535, TA1537, TA1538, TA98 and TA100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Toxicity prescreen:
Treatment was performed by combining 0.1 mL tester strain, 0.1 mL of the appropriate concentration of the test article or solvent and 2 mL of molten top agar (supplemented with 0.5 mM histidine / 0.5 mM biotin). The tubes were vorteced and the mixture was poured onto minimal glucose plates, evenly distributed, and allowed to solidify. Within an hour the plates were inverted and incubated in the dark at 37°C for 48 hours. All cultures/plates were identified using computer-generated adhesive labels that included information regarding study number, date, strain, test/control article and +-S9.
Mutation Assay (and Retest):
Treatment for the mutation assay was performed exactly as described in the toxicity prescreen, except that the test and control articles were evaluated in triplicate cultures in all five tester strains in the presence and absence of an exogenous metabolic activation system (S9). Cultures treated in the presence of S9 containced 0.5 mL of the S9 mixture. The S9 mixture contained 8 mM MgCl2, 33 mM KCl, 4 mM NADP, 5 mM glucose-6-phosphate, 100 mM Na2HPO4 (pH 7.4) and 6% (v/v) Aroclor 1254-induced male Sprague-Dawley rat liver homogenate.
DURATION
- Exposure duration: 48 hours
- Selection time (if incubation with a selection agent): 48 hours (simultaneous with exposure)
SELECTION AGENT (mutation assays): Histidine
NUMBER OF REPLICATIONS:triplicate
DETERMINATION OF CYTOTOXICITY
- Method: Inhibited growth: characterized by the reduced or absent bacterial lawn and/or the presence of pindot colonies - 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. Statistical analyses were performed using the program developed by Snee and Irr (1981), with significance established at the 95% confidence limit. 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 result is considered equivocal. A negative result is defined as the absence of a statistically significant or dose-dependent increase in the number of histidine-independent revertants.
- Statistics:
- Statistical analyses are performed only when a 50% increase in revertant frequency, relative to the concurrent negative controls, is observed. This 50% "trigger" was selected based upon the normal, spontaneous variation observed among replicate negative control cultures, as well as spontaneous fluctuation observed in this laboratory among groups of cultures treated with a variety of test articles judged to be negative in this assay.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 500 µg/plate and upwards
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: not specified
- Precipitation: no precipitation has been observed
- Other: sterility results: No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 and Sham mixes.
RANGE-FINDING/SCREENING STUDIES:
Toxicity of the test article was determined in a preliminary toxicity prescreen by evaluating the growth of the background lawn and/or frequency of spontaneous revertants. The test article was evaluated at doses of 50, 167, 500, 1670 and 5000 µg/plate in the absence of S9. Each test article dose, as well as the appropriate solvent control, was evaluated in duplicate cultures in strains TA1538 and TA100.
Based upon the results of the toxicity prescreen, the dose levels selected for the mutation assay were 167, 500, 1670, 5000, 7500 and 10000 µg per plate.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive/Negative historical control data: All positive and negative control values were within acceptable limits.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Results of the toxicity prescreen indicated the test item was not toxic to either strain at doses of 50, 167, 500, 1670 and 5000 µg/plate.
In the Mutation Assay, inhibited growth (characterized by a reduced background lawn and/or the presence of pindot colonies) was observed in all strains at doses of 500, 1670, 5000, 7500 and/or 10000 µg/plate with S9. Therefore, the test item was reevaluated in all five strains at doses of 16.7, 50, 167, 500, 1670 and 5000 µg/plate with S9 (fewer than four acceptable doses with S9 were available for most strains in the original assay). Inhibited growth again was observed in all strains ad doses of 500, 1670 and/or 5000 µg/plate with S9.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of the results: negative with and without metabolic activation
The results for test article were negative in the Ames/Salmonella Plate Incorporation Assay under the conditions, and according to the criteria, of the test protocol
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