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EC number: 216-014-7 | CAS number: 1474-02-8
- 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:
- 2005-05-12 to 2005-08-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Only three strains are tested. However, an expert statement is added in the field "any other remarks" to justify the fact that no further testing is necessary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Only 3 tester strains were used.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Only 3 tester strains were used.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
- EC Number:
- 216-014-7
- EC Name:
- N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide
- Cas Number:
- 1474-02-8
- Molecular formula:
- C21H26N2O
- IUPAC Name:
- N-(1-benzylpiperidin-4-yl)-N-phenylpropanamide
- Details on test material:
- - Name of test material (as cited in study report): T424
- Substance type: no data
- Physical state: white solid
- Analytical purity: 100 %
- Impurities: no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: batch 9852
- Expiration date of the lot/batch: 2005-12-31
- Stability under test conditions: no data
- Storage condition of test material: room temperature, protected from light
- Other: solubility in water = 0.13 g/L; solubility in ethanol >500 g/L
Constituent 1
- Specific details on test material used for the study:
- Description: white solid
Batch number:RT000424G1A251
Purity: 100 %
Stability in solvent: Not indicated by sponsor
Solubility in water: 0.13 g/L
Solubilityin ethanol: > 500 g/L
Storage conditions: Room temperature, protected from light
Expiry date: 2005-12-31
Method
- Target gene:
- histidine locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100 and TA102
- Details on mammalian cell type (if applicable):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/B-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-experiment/Experiment 1: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment 2: 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide
- Remarks:
- Without metabolic activation (S9): for TA100 at 10 μg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- Without metabolic activation (S9): for TA98 at 10 μg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation (S9): for TA102 at 4 μg/plate
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation (S9): for all strains, 2.5 μg/plate for strains TA98 and TA100 and 10 μg/plate for TA102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation) (pre-experiment, experiment I); preincubation (experiment II).
Experiment I: in agar (plate incorporation)
In the plate incorporation assay, the following materials were mixed in a test tube and poured onto the selective agar plates:
- 100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control);
- 500 μL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test without metabolic activation);
- 100 μL bacteria suspension (test system, pre-culture of the strains);
- and 2000 μL overlay agar.
Experiment II: preincubation
- In the pre-incubation assay, 50 μL test solution, solvent or 100 μL positive control, 500 μL S9 mix/S9 mix substitution buffer and 100 μL bacterial suspension were mixed in a test tube and incubated at 37 °C for 60 minutes. After pre-incubation, 2.0 mL overlay agar (45°C) was added to each tube. The mixture
was poured on minimal agar plates.
- After solidification, the plates from both assays were incubated upside down for at least 48 hours at 37°C in the dark.
DURATION:
- Preincubation period: 60 minutes (experiment II)
- Exposure duration: at least 48 hours
- Selection time: 48h (simultaneous with exposure)
SELECTION AGENT: histidine
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn - Evaluation criteria:
- The test substance was considered a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice the colony count of the corresponding solvent control was observed.
A dose dependent increase was considered biologically relevant if the threshold was exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration was judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold was regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remained within the historical range of negative and solvent control such an increase was not considered biologically relevant. - Statistics:
- A statistical analysis of the data was not required.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Evaporation from medium: no data
- Water solubility: 0.13 g/L in water
- Precipitation: none
RANGE-FINDING/SCREENING STUDIES:
Experiment 1 was used as the range-finding test. See relevant sections
COMPARISON WITH HISTORICAL CONTROL DATA:
Appropriate reference mutagens were used as positive control. They showed a distinct increase in induced revertant colonies.The positive control mean values in experiment 1 for strains TA100 and TA102 were slightly above the max values in the historical data.The positive control mean value in experiment 2 for strain TA98 was slightly above the max value in the historical data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
see below - Remarks on result:
- other: strain/cell type: TA98, TA100, TA102
Any other information on results incl. tables
Table 2. Reduced background growth was observed at the following concentrations (ug/plate) |
||||
Strain |
Experiment 1 |
Experiment 2 |
||
|
Without S9 |
With S9 |
Without S9 |
With S9 |
TA98 |
2500-5000 |
2500-5000 |
1000-5000 |
1000-5000 |
TA100 |
2500-5000 |
2500-5000 |
1000-5000 |
1000-5000 |
TA102 |
/ |
2500-5000 |
1000-5000 |
1000-5000 |
Toxic effects, evident as a reduction in the number of revertants were observed at the following concentrations (ug/plate) |
||||
Strain |
Experiment 1 |
Experiment 2 |
||
|
Without S9 |
With S9 |
Without S9 |
With S9 |
TA98 |
2500-5000 |
2500-5000 |
1000 -5000 |
1000-5000 |
TA100 |
/ |
2500-5000 |
2500-5000 |
2500-5000 |
TA102 |
5000 |
2500-5000 |
1000-5000 |
1000-5000 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
The test substance was assessed for its potential to induce gene mutations according to the plate incorporation test and the pre-incubation test using Salmonella typhimurium strains TA98, TA100 and TA102 in the presence and absence of metabolic activation. Based on the results of the study, it was concluded that the test substance was considered negative for mutagenic potential (base pair changes and frameshift mutations) in the test system.
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