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EC number: 627-580-3 | CAS number: 53617-35-9
- 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:
- 10 - 27 Sep 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- This study was conducted in accordance with "Standards for Toxicity Investigations" (Ministry of Labor, Notification No. 77, September 1, 1988 and Notification No. 67, June 2, 1997), and "Procedures of Mutagenicity Test Using Microorganisms and Evaluation of Test Results" (Ministry of Labor, Official Notification, February 8, 1999) and "III Mutagenicity test" of "Reverse-Mutation Assay in Bacteria" prescribed in "Testing Methods Relating to the New Chemical Substances" (Notification No. 1121002 of the Pharmaceutical and Food Safety Bureau, MHLW, No. 2 (2003.11.13) of the Manufacturing Industries Bureau, METI, No. 031121002 of the Environmental Health Department, MOB (November 21, 2003).
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(piperidin-4-yl)morpholine
- EC Number:
- 627-580-3
- Cas Number:
- 53617-35-9
- Molecular formula:
- C9H18N2O
- IUPAC Name:
- 4-(piperidin-4-yl)morpholine
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with a combination of phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- First experiment (range finding test): 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate with and without metabolic activation
Second experiment (main test): 156, 313, 625, 1250 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water
- Justification for choice of solvent/vehicle: The test substance solution of 50.0 mg/mL prepared with distilled water was considered to be stable, nased on the facts that there were no change in color, exothermic reaction nor gas generation at room temperature within 2 h after preparation
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (0.5 µg/plate) for TA1535; furylfuramide (0.01 or 0.1 µg/plate) for TA100, TA98 and WP2uvrA; ICR-191 (0.5 µg/plate) for TA1537; +S9: 2 aminoanthracene (0.5, 1, 2 or 10 µg/plate) for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: bacterial growth inhibition - Evaluation criteria:
- The substance was judged to be positive when the number of revertant colonies increased to twice or more than that in the negative control and when the responses were dose-related and/or reproducible. The other cases were judged to be negative.
- Statistics:
- Mean values were calculated.
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:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated 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:
- cytotoxicity
- Remarks:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated 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:
- cytotoxicity
- Remarks:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated 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:
- cytotoxicity
- Remarks:
- at 5000 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test substance was not observed.
RANGE-FINDING/SCREENING STUDIES: The pre-experiment served as Experiment I (all strains were tested in the pre-experiment).
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
- Negative (solvent/vehicle) historical control data:
Any other information on results incl. tables
Table 1: Results of the main test
With or without S9-Mix | Test substance concentration µg/plate |
Mean number of revertant colonies per plate average of 2 plates |
||||
Base-pair substitution type | Frameshift type | |||||
TA 100 | TA1535 | WP2uvrA | TA98 | TA1537 | ||
– | 0 | 102 | 15 | 26 | 19 | 8 |
– | 156 | 119 | 11 | 25 | 23 | 14 |
– | 313 | 114 | 19 | 30 | 28 | 8 |
– | 625 | 119 | 10 | 28 | 20 | 11 |
– | 1250 | 132 | 17 | 27 | 21 | 8 |
2500 | 123 | 17 | 18 | 23 | 8 | |
– | 5000* | 97 | 6 | 28 | 10 | 3 |
Positive controls, –S9 | Name | AF-2 | NaN3 | AF-2 | AF-2 | ICR-191 |
Concentrations (μg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 0.5 | |
Mean No. of colonies/plate (average of 2) | 777 | 253 | 331 | 360 | 1387 | |
+ | 0 | 111 | 12 | 28 | 24 | 20 |
+ | 156 | 114 | 18 | 30 | 24 | 18 |
+ | 313 | 107 | 22 | 36 | 30 | 15 |
+ | 625 | 107 | 17 | 21 | 27 | 10 |
+ | 1250 | 121 | 12 | 33 | 28 | 18 |
+ | 2500 | 122 | 13 | 30 | 30 | 10 |
5000* | 105 | 8 | 34 | 23 | 12 | |
Positive controls, +S9 | Name | 2AA | 2AA | 2AA | 2AA | 2AA |
Concentrations (μg/plate) | 1 | 2 | 10 | 0.5 | 2 | |
Mean No. of colonies/plate (average of 2) | 1433 | 285 | 379 | 314 | 484 |
AF-2 = Furylfuramide
NaN3: Sodium azide
2AA = 2-Aminoanthracene
* = bacterial growth inhibition was observed
Table 2: Historical control data (Mar - Aug 2010)
Negative control | -S9 mix | +S9 mix | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |
Mean | 109 | 11 | 24 | 20 | 9 | 114 | 10 | 29 | 29 | 18 |
3xSD | 16 | 4 | 6 | 6 | 4 | 17 | 4 | 7 | 7 | 6 |
Max | 157 | 23 | 42 | 38 | 21 | 165 | 22 | 50 | 50 | 36 |
Min | 61 | 1 | 6 | 2 | 1 | 63 | 1 | 8 | 8 | 1 |
Positive control | -S9 mix | +S9 mix | ||||||||
TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | TA100 | TA1535 | WP2uvrA | TA98 | TA1537 | |
Chemical | AF-2 | NaN3 | AF-2 | AF-2 | ICR-191 | 2AA | 2AA | 2AA | 2AA | 2AA |
Dose | 0.01 | 0.5 | 0.01 | 0.1 | 0.5 | 1 | 2 | 10 | 0.5 | 2 |
Mean | 712 | 311 | 353 | 440 | 1617 | 1027 | 257 | 541 | 304 | 300 |
3xSD | 70 | 50 | 57 | 79 | 268 | 145 | 46 | 89 | 34 | 76 |
Max | 922 | 461 | 524 | 677 | 2421 | 1462 | 395 | 808 | 406 | 528 |
Min | 502 | 161 | 182 | 203 | 813 | 592 | 119 | 274 | 202 | 72 |
AF-2 = Furylfuramide
NaN3: Sodium azide
2AA = 2-Aminoanthracene
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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