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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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-05-09 to 2016-06-09
- 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 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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): T000425
- Substance type: no data
- Physical state: white solid
- Analytical purity: 100%
- Impurities (identity and concentrations): no data
- 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: no data
- Storage condition of test material: room temperature
- Other: solubility: 43 g/L in water, 500 g/L in ethanol
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations final test: 10, 18, 32, 56, 100 mg/L
- Sampling method: samples for possible analysis were taken form all test concentrations and the control at t=0 and t=48h. 1.4 mL of volume was taken from the approximate centre of the test vessels. 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 1.4 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: Preparation of test solutions started with the highest test concentration of 100 mg/L. No special treatment other than vigorous shaking and a 5 minute treatment period with ultrasonic waves were needed to fully dissolve the test item in the test medium. The pH was adjusted with HCl (1 mol/L, Merck, Darmstadt, Germany) from 9.5 to 7.8 and from 9.4 to 8.0 in the combined limit/range-finding and the final test, respectively. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no, final test solutions were clear and colourless
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 litres of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no
ACCLIMATION
- Acclimation period: max. 4 weeks
- Acclimation conditions (same as test or not): yes
- Type and amount of food: fresh water algae.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L as CaCO3
- Test temperature:
- 20-21°C
- pH:
- At t= 0h: 8.0 - 8.1
At t= 48h: 7.9-8.0 - Dissolved oxygen:
- At t= 0h: 8.7-8.8 mg/L
At t= 48h: 8.9-9.0 mg/L - Salinity:
- not relevant
- Nominal and measured concentrations:
- Final test
Nominal concentrations (mg/L): 10, 18, 32, 56, 100
Measured concentrations (mg/L) at t=0h: 9.72, 17.5, 31.6, 54.4, 99.5
Measured concentrations (mg/L) at t=48h: 9.56, 17.3, 31.2, 54.2, 98.1
Samples taken from the control and all concentrations were analysed. The measured concentrations were in agreement with the nominal concentrations throughout the test duration (96-99% relative to the nominal concentrations). - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 80mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
- Adjustment of pH: no
- Light intensity: no data
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: x1.8
- Range finding study
- Test concentrations: 0.10, 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 concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 73 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% C.L.: 62-86 mg/L
- Details on results:
- - Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
- 24-h EC50: > 100 mg/L (95% C.L.: not determined) - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Concentrations: 0.10, 0.18, 0.32, 0.56, 1.0 and 1.8 mg/L and control.
- EC50/LC50: 48-h EC50 = 0.29 mg/L with a 95% confidence interval between 0.26 and 0.31 mg/L.
- Dose/response: The actual responses were below the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was just below the expected range of 0.3
to 1.0 mg/L. Hence, the sensitivity of this batch of Daphnia magna was slightly above the sensitivity of batches previously tested at WIL Research Europe. - Reported statistics and error estimates:
- The 24-h EC50 could not be calculated because the observed effects were below 50%. The 48h-EC50 value was calculated from the logits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations (nominal) using the maximum likelihood estimation method.
ToxRat Professional v. 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analyses.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of T000425 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202.
Based on analytically confirmed nominal concentrations, the 48-h EC50 was determined to be 73 mg T000425/L (95% CL 62-86 mg/L). The results of the test can be considered reliable without restriction.
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