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Diss Factsheets
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EC number: 216-543-3 | CAS number: 1609-66-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-04-27 to 2005-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline 423 (Acute Oral Toxicity-Acute Toxic Class Method) and EU method B.1.tris (Acute Oral Toxicity-Acute Toxic Class Method) without deviation.
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:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- N-phenyl-N-piperidin-4-ylpropionamide
- EC Number:
- 216-543-3
- EC Name:
- N-phenyl-N-piperidin-4-ylpropionamide
- Cas Number:
- 1609-66-1
- Molecular formula:
- C14H20N2O
- IUPAC Name:
- N-phenyl-N-piperidin-4-ylpropionamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-1594255-AAA (T000425)
- Physical state: solid (powder)
- Appearance: white
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): T425
- Substance type: no data
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): unknown
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 00454795
- Expiration date of the lot/batch: 2005-12-31
- Stability under test conditions: Stable under storage conditions. Stability of test substance dilutions
was unknown.
- Storage condition of test material: at room temperature (20 ± 5 deg C), light protected
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC, Ltd., Laboratory Animal Services, CH-4414 Fűllinsdorf, Switzerland
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 177-201 grams
- Fasting period before study: 17 to 20 hours (access to water was permitted)
- Housing: in groups of 3 in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 4/05, ad libitum
- Water (e.g. ad libitum): community tap water from Fűllinsdorf ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 22 ± 3 deg C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL, 0.005 g/mL, or 0.03 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The vehicle was chosen after a solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): 1107712 24104041
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED:
- 10 mL/kg
DOSAGE PREPARATION (if unusual):
- not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 2000, 50, and 300 mg/kg body weight
- No. of animals per sex per dose:
- There were two groups of 3 animals in each group per dose. Therefore, a total of 6 animals were used at each dose level.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/viability and clincial signs were observed daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3, and 5 hours after administration on test day 1 and twice daily during days 2-15. Body weights were obtained on test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Mortality:
- One 2000 mg/kg treated animal had to be sacrificed in extremis for ethical reasons approximately 3.5 hours after the test substance application. All remaining 2000 mg/kg treated animals were found dead approximately 0.5, 2.5, 3 or 5 hours after treatment.
- Clinical signs:
- Slightly ruffled fur, hunched posture and slight sedation were observed in all 2000 mg/kg treated animals from the 0.5- to the 2- or 3-hour reading, respectively. Two animals screamed by hand touch between the 0.5- and the 2- or 3-hour reading and slight tremor was noted in three animals at the 2- and/or 3-hour reading. Poor coordination was also noted in two animals at the 0.5-hour reading.
Slightly ruffled fur, exophthalmos and corneal opacity was observed in three 50 mg/kg treated animals from the 3- to the 5-hour reading.
Slightly ruffed fur was noted in all 300 mg/kg treated animals from the 0.5- to the 5-hour reading and persisted in one animal up to test day 2 and in three animals up to test day 3. Slight sedation was also noted in three animals from the 0.5-or 1-hour reading to the 5-hour reading, and in the three remaining animals at the 2- and 3-hour reading. Hunched posture was noted in three animals at the 2-hour reading and persisted up to the 5-hour reading in two animals. - Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- Liquid contents were noted in the stomach of all animals treated at 2000 mg/kg at their unscheduled necropsy. Two 2000 mg/kg treated animals showed also congested lungs. Liquid contents (reddish) were also noted in the ileum and/or duodenum and jejunum of three 2000 mg/kg treated animals. Congested lungs were also noted in two 50 mg/kg treated animals at their scheduled necropsy. No macroscopic findings were recorded in the remaining animals treated at 50 and 300 mg/kg at their scheduled necropsy.
- Other findings:
- - Organ weights: no data
- Histopathology: no data
- Potential target organs: no data
- Other observations: no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The median lethal dose of the test substance after single oral administration to female rats, observed over a period of 14 days is: 300 mg/kg body weight < LD50 (rat) < 2000 mg/kg body weight.
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