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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- 23 APR 2021 to 10 MAY 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 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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-chloro-N-[2-methoxy-4-(morpholin-4-yl)-5-nitrophenyl]pyrimidin-2-amine
- Cas Number:
- 2270944-70-0
- Molecular formula:
- C15H16ClN5O4
- IUPAC Name:
- 4-chloro-N-[2-methoxy-4-(morpholin-4-yl)-5-nitrophenyl]pyrimidin-2-amine
- 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: I20CD1048
- Expiration date of the lot/batch: 2022-0-22 (retest date)
- Purity test date: 2020-05-11 (certificate of analysis release date)
- Physical appearance: Light yellow to dark orange solid
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. 1.5 mL of volume was taken from the approximate centre of the test solutions. 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:
- The batch of JNJ-73848242-AAA (T003901) tested was a light yellow to dark orange solid with a purity of 100.7% and was not completely soluble in test medium at the loading rate initially prepared. No correction was made for the purity/composition of the test item.
Preparation of test solutions started with a loading rate of 100 mg/L applying fifteen-minutes of ultrasonic waves followed by a three-day period of magnetic stirring to ensure maximum
dissolution of the test item 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 highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS 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
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation: < 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: suspension 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:
- 180 mg/L
- Test temperature:
- 19-21 °C
- pH:
- control (start/end): 7.8/8.1, 100 mg/L (start/end): 7.8/8.1
- Dissolved oxygen:
- control (start/end): 8.5/9.2 mg/L, 100 mg/L (start/end): 8.5/9.1
- Nominal and measured concentrations:
- Nominal: Solutions containing 0.10, 1.0, 10, and 100% of the SS prepared at a loading rate of 100 mg/L, measured: Highest test concentration: 0.39 mg/L (Geometric mean concentration). //
Combined limit/range finding test: Samples taken from the highest test concentration were analysed. The measured concentration at the start of the test was 0.39 mg/L. During the exposure period, the concentration remained stable, i.e. was at 100% of initial at the end of the test. Based on these results, the geometric mean concentration was calculated to be 0.39 mg/L for the 100% SS concentration, this was used to express effect parameters. - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker, 60 mL, all-glass
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 for highest, intermediate: 2
- No. of vessels per control (replicates): 4
- Test medium: The following salts (analytical grade) were added to tap water purified by Reverse Osmosis: CaCl2.2H2O: 211.5 mg/L, MgSO4.7H2O: 88.8 mg/L, NaHCO3: 46.7 mg/L, KCl: 4.2 mg/L
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: 10
- combined Limit/Range finding study
- Test concentrations: 0.10, 1.0, 10 and 100% of a SS prepared at 100 mg/L (setup: combined range finder/limit 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.:
- > 0.39 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - EC50 (24h): > 0.39 mg/L
- Immobility of control: none
- Other adverse effects control: no
- Abnormal responses: none
- Effect concentrations exceeding solubility of substance in test medium: yes - Results with reference substance (positive control):
- expected sensitivity of test organism towards potassium dichromate
- Reported statistics and error estimates:
- No EC50 could be calculated because the test item proved to be not acutely toxic to Daphnia magna (EC50 > maximum concentration tested)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The objective of the study was to evaluate JNJ-73848242-AAA (T003901) 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 combined limit/range-finding test and saturation test were performed. The study met the acceptability criteria prescribed by the study plan and was considered valid. In conclusion, under the conditions of the present study with Daphnia magna, no immobility or other effects were recorded at any of the concentrations of JNJ-73848242-AAA (T003901) tested. The 48h-EC50 for Daphnia magna exposed to JNJ-73848242-AAA (T003901) was beyond the range of concentrations tested, i.e. exceeded a geometric mean measured concentration of 0.39 mg/L, which was considered the maximum soluble concentration in test medium. 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.