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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Biodegradation in water: screening tests
Administrative data
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-03-01 to 2021-04-06
- 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 301 F (Ready Biodegradability: Manometric Respirometry Test)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO International Standard 10634. "Water Quality - Preparation and treatment of poorly water-soluble organic compounds for the subsequent evaluation of their biodegradability in an aqueous medium"
- Version / remarks:
- 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-[4-[4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl]pyrimidin-2-yl]-6-methoxy-4-(morpholin-4-yl)benzene-1,3-diamine
- Cas Number:
- 1903009-56-2
- Molecular formula:
- C27H32N8O2
- IUPAC Name:
- N-[4-[4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl]pyrimidin-2-yl]-6-methoxy-4-(morpholin-4-yl)benzene-1,3-diamine
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: I20ID2980
- Purity, including information on contaminants, isomers, etc.: 99.3%
- Expiration date of the lot/batch: 2022-09-17 (retest date)
- Purity test date: 2020-10-26 (certificate of analysis release date)
- Physical appearance: beige powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: not available
- Solubility and stability of the test substance in the solvent vehicle: solubility in water: not available
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Remarks:
- The source of test organisms was activated sludge freshly obtained from a municipal sewage treatment plant: 'Waterschap Aa en Maas', 's-Hertogenbosch, The Netherlands, receiving predominantly domestic sewage
- Details on inoculum:
- The freshly obtained sludge was kept under continuous aeration until further treatment. Before use, the sludge was coarsely sieved (1 mm). After treatment, the concentration of suspended solids (SS) was determined to be 4.2 g/L in the concentrated sludge as used for the test. The sludge was used as inoculum at a concentration of 7.2 mL per liter of mineral medium, leading to a final concentration SS of 30.0 mg/L.
- Duration of test (contact time):
- 28 d
Initial test substance concentrationopen allclose all
- Initial conc.:
- 28.7 mg/L
- Based on:
- test mat.
- Initial conc.:
- 80.6 mg/L
- Based on:
- ThOD
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium: test water prepared according to test guidelines.
* mineral stock solution A: 8.5 g KH2PO4, 21.75 g K2HPO4, 33.4 g Na2HPO4.2H2O in 1 L Milli-Q water
* mineral stock solution B: 0.5 g NH4Cl dissolved in 1 L Milli-Q water
* mineral stock solution C: 36.4 g CaCl2.2H2O dissolved in 1 L Milli-Q water
* mineral stock solution D: 22.5 g MgSO4.7H2O dissolved in 1 L Milli-Q water
* mineral stock solution E: 0.25 g FeCl3.6H2O, 0.56 K2-EDTA dissolved in 1 L Milli-Q water
* Final test medium: 10 mL of solution A and and 1 mL of solutions B through D per L of test medium were added to 0.244 L distilled water.
- Additional substrate: no
- Test temperature: 21.7 - 22.2°C
- pH: 7.60-8.50; measured prior to testing in each test flask before addition of inoculum, and again in each test flask at the end of the incubation period.
- pH adjusted: no
- Suspended solids concentration: initially 30 mg dw/L
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: Soda lime pellets (Sigma-Aldrich, Steinheim, Germany).
- Number of culture flasks/concentration: 2
- The CO2 produced in each test bottle reacted with the CO2 absorbent in the rubber gaskets. As gaseous O2 was converted into gaseous CO2 that was absorbed, the gas pressure in the test system slowly decreased. This decrease in air pressure was measured by the respirometer heads and automatically converted into oxygen consumption (mg O2/L).
- Each vessel is connected with an oxygen-producing unit (sulphuric acid-copper solution in an electrolytic bottle) and a manometer.
SAMPLING
- Sampling frequency: every day during 28 days
CONTROL AND BLANK SYSTEM
- Biotic control: yes, two replicates with inoculum
- Toxicity control: yes
- Procedure control: yes, 1 replicate with reference substance and inoculum
Reference substance
- Reference substance:
- benzoic acid, sodium salt
- Remarks:
- Sodium acetate
Results and discussion
- Test performance:
- 1. The procedural control item was biodegraded by at least 60 % (actual value: 73 %) within 14 days.
2. The difference of duplicate values for %-degradation of the test item at the end of the test was less than 20 (actual value: 0 %).
3. The total oxygen uptake in the blank at the end of the test did not exceed 60 mg O2/L (average actual value: 28.0 mg O2 per litre).
4. The pH value in the test item bottles at the end of the test was within the range 6.0-8.5 (7.6 for both vessels).
Since all validity criteria were satisfied the study was considered to be valid.
% Degradation
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 0
- Remarks on result:
- other: in both test vessels
- Details on results:
- The relative biodegradation values calculated from the measurements performed during the test period revealed no biologically relevant biodegradation of JNJ-73848281-AAA (T003904), based on ThOD (0 % in both test vessels).
In the toxicity control, more than 25 % biodegradation occurred within 14 days (37 %, based on ThOD). Therefore, the test item was considered not to inhibit microbial activity.
BOD5 / COD results
- Results with reference substance:
- Functioning of the test system was checked by testing the procedural control item sodium acetate, which showed a normal biodegradation curve
Any other information on results incl. tables
Monitoring of Temperature and pH
The temperature recorded in a vessel with water in the same incubator varied between 21.7 and 22.2 °C and complied with the requirements as laid down in the Study Plan. The pH values of the different test media are presented in the table below.
pH Values of Different Test Media
Test medium: | Day 0: | Day 14: | Day 28: |
Blank control (A) | 7.7 | - | 7.6 |
Blank control (B) | 7.7 | - | 7.6 |
Procedural control (A) | 7.7 | 8.5 | - |
Procedural control (B) | 7.7 | 8.5 | - |
JNJ-73848281-AAA (T003904) (A) | 7.7 | - | 7.6 |
JNJ-73848281-AAA (T003904) (B) | 7.7 | - | 7.6 |
Toxicity control | 7.7 | 8.5 | - |
The pH of all test vessels at the start of the test (Day 0) was outside the range laid down in the Study Plan. It was 7.7, which is only 0.1 pH unit above the recommended range. Such a small deviation does not impact the viability of the inoculum.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- A 28-d ready biodegradability test (OECD 301F, manometric respirometry test) using unadapted activated sludge from a predominantly domestic waste water treatment plant indicated that JNJ-73848281-AAA (T003904) was not readily biodegradable under the conditions of the test (initial concentrations 28.7 mg/L). The test substance showed 0% biodegradation (in both test bottles A and B, based on ThOD). The test substance did not inhibit microbial activity at the concentration used in the test. 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.