Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 632-673-7 | CAS number: 26033-20-5
- 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:
- 16 NOV 2020 to 22 JAN 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- April 13 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-phenyl-1H-pyrazole-4-carbaldehyde
- EC Number:
- 632-673-7
- Cas Number:
- 26033-20-5
- Molecular formula:
- C10H8N2O
- IUPAC Name:
- 3-phenyl-1H-pyrazole-4-carbaldehyde
- 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: M19LD3723
- Expiration date of the lot/batch: 2021-11-11 (retest date)
- Purity test date: 2020-05-04 (certificate of analysis release date)
- Purity: 103.6 %
- Physical appearance: light yellow powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: not indicated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: not indicated
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 1.8 mL of volume was taken from the approximate centre of the test solutions. Samples were stored in a freezer (≤-15°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:
- The batch of JNJ-39125190-AAA (T003897) tested was a light-yellow powder with a purity of 103.6% and was 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 a one-hour period of ultrasonic treatment to accelerate dissolution of the test item in medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All test solutions were 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
- Straus, 1820, at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions
- 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)
- 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: suspension of fresh water algae, daily
- Feeding during test: no
ACCLIMATION
- Acclimation period: not relevant
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- The hardness of test medium expressed as CaCO3: 180 mg/L
- Test temperature:
- 19-20 °C, continuous measurement
- pH:
- 7.9 at start, 8.0 at end, for all test concentrations
- Dissolved oxygen:
- control: 9.2 (start)-8.8 (end) mg/L, 4.6 mg/L: 9.1 (start)-8.8 (end) mg/L, 10 mg/L: 9.1 (start)-8.7(end) mg/L, 22 mg/L: 9.1 (start)-8.6 (end) mg/L, 46 mg/L: 9.1 (start)-8.6 (end) mg/L, 100 mg/L: 9.4 (start)-8.6 (end) mg/L
- Salinity:
- not relevant
- Nominal and measured concentrations:
- nominal (mg/L): 0-4.6-10-22-46-100, measured (mg/L; 0h): nd, 4.54, 9.91, 21.6, 44.3, 97.4, measured (mg/L; 48h): nd, 4.43, 9.67, 21.0, 42.8, 95.4. The measured concentrations were in agreement with the nominal concentrations, i.e. varied between 93 and 99% relative to the nominal levels at the start and end of the exposure. Based on these results, effect parameters were based on analytically confirmed nominal concentrations.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 60 mL (containing 50 mL of test solution), all-glass
- 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: 2.2
- Range finding study: yes
- Test concentrations: 1.0, 10 and 100 mg/L (combined limit/range-finding), 4.6-10-22-46-100 mg/L (final test)
- 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.:
- 15 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - EC50(24h): 68 mg/L (61-75)
- 24 hours: total immobilised: 4.6-10-22 mg/L: 0, 46 mg/L: 1, 100 mg/L: 19
- 48 hours: total immobilised: 4.6 mg/L: 0, 10 mg/L: 10, 22 mg/L: 13, 46 mg/L: 16, 100 mg/L: 20
- No immobility was observed in the control and at the two lowest test concentrations throughout the test. No daphnids were immobilized at 10 mg/L after the first 24 hours of exposure, while 10% immobility was found at the end of the test. All daphnia exposed to the highest test concentration were immobile after 24 hours of exposure and onwards - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- The batch of Daphnia magna tested showed expected sensitivity to Potassium dichromate, based on the range specified in ISO International Standard 6341, October 2012 and historical range of reference tests performed by the Test Facility in the last ten years. - Reported statistics and error estimates:
- - The 24h- and 48h-EC50 were calculated by applying the Spearman-Karber procedure (nonlinear; without trimming) on the percentages of affected daphnids and the logarithms of the corresponding nominal test item concentrations. ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analysis
- EC50 (48h): 67.878 (95% confidence interval: 61.083-75.458)
- EC50 (24h): 15.2 (95% confidence interval: 11.581-20.060)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The objective of the study was to evaluate JNJ-39125190-AAA (T003897) for its ability to generate acute toxic effects on the mobility of Daphnia magna during an exposure period of 48 hours and, if possible, to determine the EC50 at 24 and 48 hours of exposure. A full test was performed based on the results of a preceding combined limit/range-finding test. The study met the acceptability criteria prescribed by the study plan and was considered
valid.
In conclusion, the 48h-EC50 for Daphnia magna exposed to JNJ-39125190-AAA (T003897) was 15 mg/L based on analytically confirmed nominal concentrations (95% confidence interval between 12 and 20 mg/L). The results of the test can be considered reliable without restriction.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.