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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-05-04 to 2005-06-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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:
- yes
- Remarks:
- Test substance purity was not reported.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Test substance purity was not reported.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
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: Solid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Lot/batch No.: RT000424G1A251
- Expiration date of the lot/batch: 2005-12-31
- Stability under test conditions: No data
- Storage condition of test material: at room temperature (range of 20 +-5°C), light protected
- Other: No data
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RT000424G1A251, Janssen Pharmaceutica N.V.
- Expiration date of the lot/batch: 31-December-2001
- Purity: Unknown
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: Stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: Unknown
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Laboratory Animal Services, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: 7-12 weeks
- Weight at study initiation: 173.4-193.8 g (prior to administration)
- Fasting period before study: 19 h (access to water was permitted)
- Housing: in groups of three 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. Results of analysis are archived at RCC Ltd.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analysis are archived at RCC Ltd.
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 22 +- 3
- Humidity (%): 30-70% (values above 70% during cleaning process possible)
- Air changes (per hr): air conditioned, 10-15 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light
- Other: music during the daytime light period
IN-LIFE DATES: From: 2005-05-04 To: 2005-06-08
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL, 0.03 g/mL, or 0.005 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The vehicle was chosen after a solubility trial was performed before the study initiation date.
- Lot/batch no. (if required):11077124 104041
- Expiration date: 2006-02-28
- Description: Colorless viscous liquid
- Stability: Stable under storage conditions (20+-5 deg C), light protected
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
- Doses:
- 2000 mg/kg (one group of 3 animals)
300 mg/kg (one group of 3 animals)
50 mg/kg (two groups of 3 animals/each) - No. of animals per sex per dose:
- 3 animals/treatment
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations mortality/viability: Daily during acclimation period. 0.5, 1, 2, 3 and 5 h after administration of test at day 1 and twice daily during days 2-15.
- Frequency of observations weighing: on test day 1 (prior to administration), 8 and 15
- Clinical signs: Daily during acclimation period. 0.5, 1, 2, 3 and 5 h after administration of test at day 1 and twice daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analyses were performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Mortality:
- All animals died or were humanely sacraficed in treatment groups 300 mg/kg and 2000 mg/kg (3 animals per treatment). No mortalities occurred at 50 mg/kg.
- Clinical signs:
- Slightly ruffled fur and exophthalmos were observed in all animals treated with 2000 mg/kg. These animals also showed slight to marked convulsions 0.5-1h after administration. One of these three animals also showed slight salivation and ventral recumbency 1 h after adminstration. Exophthalmos and marked convulsions were observed in all 30 mg/kg animals at .5 hr. No clinical signs were observed in the six animals treated with 50 mg/kg during the course of the study.
- Body weight:
- The body weights were within the range commonly recorded for this strain and age.
- Gross pathology:
- Liquid contents were found in all three animals treated with 2000 mg/kg at their necropsy. Congested lungs, liquid content in the stomach, duodenum, jejunum and ileum, and prominent follicles in the spleen were seen in all 300 mg/kg-treated animals at their necropsy. One 50 mg/kg-treated animal showed congestion to the lungs, whereas no macroscopic findings were recorded in the remaining animals treated with 50 mg/kg at their necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the female rat oral LD50 of the test substance was 50 mg/kg bw < LD50(rat) < 300 mg/kg bw (three doses tested).
According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (including all amendments) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (including all amendments) T00424 should be classified as: Toxic if swalled for acute toxicity by the oral route.
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