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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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-04-04 to 2016-05-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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: I15BB0491
- Expiration date of the lot/batch: 2021-02-04 (retest date)
- Purity test date: 2015-02-06
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
OTHER SPECIFICS:
- Name of test material (as cited in study reports): JNJ-117676-AAA (T000263)
- Physical state: solid (powder)
- Appearance: white to slightly grey powder
specific details on test material used for the study:
- Analytical purity: 99.8% (base titration: >=98.0%)
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: samples for possible analysis were taken form all test concentrations and the control at t=0 and t=72h. 3.0 mL of volume. At the end of the exposure period, the replicates were pooled at each concentration before sampling
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 3.0 mL were taken for possible analysis
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The batch of JNJ-117676-AAA (T000263) tested was a white to slightly grey powder with a purity of 99.8% and completely soluble in test medium at the concentrations tested. No correction was made for the purity/composition of the test item. Preparation of test solutions started with the highest concentration of 100 mg/L applying ultrasonic waves for a period of approximately 10 minutes followed by 49-72 minutes of magnetic stirring to accelerate the dissolution of the test item in test medium. For the combined limit/range-finding test, the pH was adjusted from 9.6 to 8.5 and for the final test, from 9.7 to 8.5 with 1 M HCl (Merck, Darmstadt, Germany). The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All final test solutions were clear and colourless.
After preparation, volumes of 50 mL were added to each replicate of the respective test concentration. Subsequently, 1 mL of an algal suspension was added to each replicate providing a cell density of 10^4 cells/mL. Six replicates of exponentially growing algal cultures were exposed to a control and a concentration of 100 mg/L. Test procedure and conditions were similar to those applied in the final test with the following exceptions:
*Three replicates per concentration were exposed to 0.10, 1.0 and 10 mg/L.
*pH was only measured in the control and the highest test concentration.
*Samples for possible analysis were taken from the control and all test concentrations at the start, after 24 hours of exposure and at the end of the test period.
*Cell densities were recorded at 24-hour intervals in the control and the limit concentration. Intermediate concentrations were measured only at the end of the exposure period.
*At the end of the test, algae were not observed to verify a normal and healthy appearance.
- Controls: yes
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1
- Source (laboratory, culture collection): In-house laboratory culture
- Method of cultivation: Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C.
ACCLIMATION
- Acclimation period: 4 days
- Culturing media and conditions (same as test or not): same as the test. 4 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 1 x 10^4 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg CaCO3/L
- Test temperature:
- 21-23°C
- pH:
- 8.0-8.2
- Dissolved oxygen:
- not reported
- Salinity:
- not applicable
- Nominal and measured concentrations:
- nominal test concentrations final test: 0, 1.0, 3.2, 10, 32 and 100 mg/L
measured test concentration final test t= 0 h: 0.010, 1.11, 3.65, 11.3, 11.5, 35.5, 115 mg/L
measured test concentration final test t= 72h: 0.0970, 1.13, 3.67, 11.6, 10.6, 36.9, 118 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass flasks
- Type (delete if not applicable): capped vessels
- Material, size, headspace, fill volume: 100 mL all-glass flasks filled with 50 mL test solution
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): no flow-through system applied
- Renewal rate of test solution (frequency/flow rate): no renewal
- Initial cells density: 10,000 cells/mL
- Control end cells density: 143,9 x 10,000 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M2 according to the OECD 201 guideline, formulated using Milli-RO water
- Culture medium different from test medium: no
- Intervals of water quality measurement: temperature measured continuously, pH at the beginning and the end of the test.
OTHER TEST CONDITIONS
- Sterile test conditions: no information
- Adjustment of pH: none
- Photoperiod: continuous illumination
- Light intensity and quality: 86 to 93 μE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm, using TLD-lamps.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: At the beginning, cells were counted using a microscope and a counting chamber. Thereafter, cell densities were determined by spectrophotometric measurement of samples at 680 nm using a spectrophotometer with immersion probe.
- effect calculated parameters: specific growth rate and yield
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
* Replicates 6 replicates of the control.
* 3 replicates of each test concentration.
* 1 or 2 replicate of each test concentration without algae.
- Range finding study
- Test concentrations: 0.1, 1.0 and 10 mg/L
- Results used to determine the conditions for the definitive study: yes. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 12 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% C.L.: 11-12 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Any stimulation of growth found in any treatment: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
- EC50 (yield) = 4.9 mg T000263 /L
- EC10 (growth rate) = 6.2 mg T000263 / L (95% C.L. 5.8-6.6 mg/L).
- EC10 (yield) = 2.0 mg T000263 / L (95% C.L. 1.7-2.2 mg/L).
- NOEC (yield) = 1.0 mg T000263 / L. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: 72-h EC50 (growth rate) = 1.0 mg/L (95% C.L.1.0 to 1.1 mg/L) - Reported statistics and error estimates:
- Calculation of ECx values was based on probit analysis using linear max. likelihood regression with the percentages of growth rate inhibition and the percentages of yield inhibition versus the logarithms of the corresponding TWA concentrations of the test item. The calculations were performed with ToxRat Professional v. 3.0.0 (ToxRat Solutions® GmbH, Germany).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- A 72-h growth inhibition test with the unicellular green alga Pseudokirchneriella subcapitata was performed with the test substance T000263 according to the OECD guideline 201. Under the test conditions, T000263 inhibited growth rate of this fresh water algae species significantly. The 72-h ECr50 was determined to be 12 mg/L.
The results of the test can be considered reliable without restrictions.
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