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EC number: 254-479-8 | CAS number: 39512-49-7
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-06-06 to 2005-06-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non-GLP study conducted according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) and EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria) with an acceptable deviation (only three tester strains were used). However, an expert statement is added in attachment and 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : Only 3 bacterial strains used and limited details on methodology were provided.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- : Only 3 bacterial strains used and limited details on methodology were provided.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(p-chlorophenyl)piperidin-4-ol
- EC Number:
- 254-479-8
- EC Name:
- 4-(p-chlorophenyl)piperidin-4-ol
- Cas Number:
- 39512-49-7
- Molecular formula:
- C11H14ClNO
- IUPAC Name:
- 4-(p-chlorophenyl)piperidin-4-ol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-117676-AAA (T000263)
- Physical state: solid (powder)
- Appearance: White, slight beige amorphous, crystalline, micropowder
Constituent 1
- Specific details on test material used for the study:
- Batch number: Code: 8693
Purity: 100 %
Stability in solvent: not indicated by sponsor
Solubility in water: 0.34 g/L
Solubilityin ethanol: >340 g/L
Storage conditions: Room temperature
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
- Additional strain / cell type characteristics:
- other: See "Any other information on materials and methods"
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-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: On the day of the experiment, the test item was dissolved inethanol and neutralized in 1 N HCl.
- 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:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation at 10 µg/plate for TA100
- Untreated negative controls:
- yes
- Remarks:
- : untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- : ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- without metabolic activation at 10 µg/plate for TA98
- Untreated negative controls:
- yes
- Remarks:
- : untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- : ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without metabolic activation at 4.0 µL/plate for TA102
- Untreated negative controls:
- yes
- Remarks:
- : untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- : ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation at 2.5 µg/plate for TA98 and TA100 and 10.0 µg/plate for TA102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (pre-experiment, experiment I); preincubation (experiment II).
- In Experiment 1 (plate incorporation), 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 S9) or S9 mix substitution buffer (for test without S9), 100 µL bacteria suspension (cf. test system, pre-culture of the strains), and 2000 µL overlay agar.
- In Experiment 2 (pre-incubation), 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 were incubated upside down for at least 48 hours at 37°C in the dark.
DURATION
- Preincubation period: 60 minutes (Experiment 2)
- Exposure duration: at least 48 hours (both experiments)
- Selection time: at least 48 hours (simultaneous with exposure)
SELECTION AGENT: histidine
NUMBER OF REPLICATIONS: 3
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 as 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 controls 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
- Precipitation: Precipitation of the test substance in the overlay agar was observed in all strains in Experiment 2 with metabolic activation at 1000 µg/plate and above.
RANGE-FINDING/SCREENING STUDIES:
- The pre-experiment was reported as main Experiment 1.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The positive controls showed a distinct increase in induced revertant colonies.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Reduced background growth and toxic effects were observed in all tester strans as described in the section "Any other information on results". - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
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 |
5000 |
5000 |
2500 -5000 |
2500 -5000 |
TA100 |
5000 |
5000 |
1000 -5000 |
5000 |
TA102 |
5000 |
5000 |
1000 -5000 |
2500 -5000 |
Toxic effects, evident as a reduction in the number of revertants were observed at the following concentrations (µg/plate) |
||||
Strain |
Experiment 1 |
Experiment 2 |
||
|
Without S9 |
With S9 |
Without S9 |
With S9 |
TA98 |
2500-5000 |
5000 |
2500 -5000 |
5000 |
TA100 |
5000 |
5000 |
2500-5000 |
5000 |
TA102 |
2500-5000 |
5000 |
1000 -5000 |
2500 -5000 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
The test substance was evaluated for mutagenic potential in the bacterial reverse mutation assay in S. typhimurium strains TA98, TA100 and TA102 in the presence and absence of S9 metabolic activation. Under the conditions of the study, the test substance was determined to be negative for mutagenic potential in all tester strains in the absence and presence of metabolic activation.
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