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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
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:
- 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:
- 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:
- 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:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: the test item was delivered by the Sponsor with Batch number: CODE: 8693
- Expiration date of the lot/batch: 31 December 2005
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), light protected
- Stability under test conditions: no data, but stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
Purified water was found to be a suitable vehicle
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 Füllinsdorf / Switzerland
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation: 185.3 g (mean)
- Fasting period before study: 19 hours (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
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period: 2005-04-27 to 2005-05-03 (females, 2000 mg/kg); 2005-04-29 to 2005-05-05 (females, 300 mg/kg); 2005-05-10 to 2005-05-16 (females, 300 mg/kg)
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: : purified water prepared at RCC Ltd.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL or 0.03 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- 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): not applicable
- Purity: reported as purified
MAXIMUM DOSE VOLUME APPLIED:
- 10 mL/kg bw
DOSAGE PREPARATION (if unusual):
- not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 2000 mg/kg bw for one group of 3 females, or 300 mg/kg bw for two groups of 3 females each
- No. of animals per sex per dose:
- three groups each with three females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded; all animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15; mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15; Body weights were recorded on day 1 (prior to administration) and on days 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 killed in extremis for ethical reasons approximately 2 1/2 hours after test item application. The two other animals also treated at 2000 mg/kg were found dead approximately 1 1/2 hours after treatment. All 300 mg/kg treated animals survived until the end of the study period.
- Clinical signs:
- observations of tremors
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weights of the animals were within the range commonly recorded for this strain and age.
- Gross pathology:
- Liquid contents were noted in the stomach of all three animals treated at 2000 mg/kg at their unscheduled necropsy. One 300 mg/kg-treated animal showed congestion of the lungs, whereas no macroscopic findings were recorded in the remaining animals treated at 300 mg/kg at their scheduled necropsies.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The purpose of the study was to assess the acute toxicity of the test substance when administered by a single oral gavage to rats, followed by an observation period of 14 days. The LD50 of the test substance after single oral administration to female rats, observed over a period of 14 days was greater than 300 mg/kg bw and less than 2000 mg/kg bw.
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