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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- FROM 21 OCT 2022 TO 28 OCT 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 023
- Report date:
- 2023
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- Adopted April 13, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Aqueous-phase Aquatic Toxicity Testing of Difficult Test Chemicals, OECD series on testing and assessment number 23 (2nd edition)
- Version / remarks:
- Adopted February 08, 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[(1-[[6-cyano-5-(trifluoromethyl)pyridin-3-yl]carbamoyl]cyclobutyl)amino]-2-fluoro-N-methylbenzamide
- Cas Number:
- 1950587-20-8
- Molecular formula:
- C20H17F4N5O2
- IUPAC Name:
- 4-[(1-[[6-cyano-5-(trifluoromethyl)pyridin-3-yl]carbamoyl]cyclobutyl)amino]-2-fluoro-N-methylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 22CN0611
- Expiration date of the lot/batch: 2023-05-11 (retest date)
- Purity: 99.9%
- Purity test date: 2022-05-31 (certificate of analysis release date)
- Physical appearance: brown powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under storage conditions: not indicated
- Stability under test conditions: not indicated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: not indicated
- Treatment of test material prior to testing: no treatment
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for possible analysis were taken from the limit concentration and the control according to the schedule below.
Frequency at t=0 h and t=48 h.
Volume 2.0 mL from the approximate center of the test solutions.
Storage Samples were stored in a freezer (set to maintain -20°C) until analysis at the analytical laboratory of the Test Facility.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to ensure maximum dissolution of the test material in medium. Thereafter, the aqueous Saturated Solution (SS) was collected by filtration through a 0.45 µm membrane filter (RC55, Whatman) and used as the limit test concentration.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The test solution was clear and colorless at the end of the preparation procedure. Any residual volumes were discarded.
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): < 24 h (from parental daphnids of more than 2 weeks old, maximum age 4 weeks)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 liters 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 cultivation: fresh water algae, daily
- Feeding during test: no
ACCLIMATION
- Acclimation period: not relevant
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- The hardness of test medium expressed as CaCO3: 180 mg/L
- Test temperature:
- 18-22°C
- pH:
- At t=0:h 7.8-8.0
At t=48h: 7.8-7.9 - Dissolved oxygen:
- At t=0h: 8.3 mg/L
At t=48h: 8.7-8.8 mg/L - Salinity:
- not relevant
- Nominal and measured concentrations:
- Combined limit/range finder test
Nominal concentrations: 0 (blank) and 100% of a SS prepared at 100 mg/L
Measured concentrations (mg/L) at t=0h:Measured concentrations (mg/L) at t=48h:
LOQ is 0.07 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 60 mL, glass beaker filled with 50 mL
- 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: adjusted ISO medium
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
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: not applicable (limit test)
- Test concentrations: 100% of a SS prepared at 100 mg/L
RANGE-FINDING STUDY
- Test concentrations: 0, 10 and 100% of a SS prepared at 100 mg/L
- Results used to determine the conditions for the definitive study: no immobility was observed in the control and the test concentrations throughout the exposure period - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.48 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Remarks on result:
- not determinable
- Details on results:
- - Immobility of control: none
- Other adverse effects control: no
- Abnormal responses: none - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: The batch of Daphnia magna tested, showed expected sensitivity to Potassium dichromate - Reported statistics and error estimates:
- the 24 and 48-h EC50 could not be calculated because no adverse effects were observed in this study
Any other information on results incl. tables
Samples taken from the limit concentration and the control were analyzed. The measured concentration at the start of the test was 0.52 mg/L, for the limit test concentration. During the exposure period, the concentrations remained stable, i.e., were at 86% relative to initial at the end of the test.
Based on these results, the geometric mean concentration of the limit test concentration was calculated to be 0.48 mg/L and used to express effect parameters.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In conclusion, the 48h-EC50 for Daphnia magna exposed to JNJ-63632335-AAA (T003671) was beyond the range of concentrations tested, i.e., exceeded a geometric mean concentration of 0.48 mg/L.
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