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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
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-03-30 to 2021-05-07
- 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:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- column elution method
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
Results and discussion
Water solubility
- Key result
- Water solubility:
- 0.425 mg/L
- Conc. based on:
- test mat.
- Remarks:
- The water solubility of a test item is specified by the saturation mass concentration of the test item in water at a given temperature and is expressed in g/L or equivalent.
- Temp.:
- 20 °C
- pH:
- >= 7.5 - <= 7.8
- Remarks on result:
- other: The pH of the aqueous samples was 7.8 and 7.5.
- Details on results:
- Preliminary Test:
The content of test item dissolved in the water sample was 0.662 mg/L.
Main Study:
The turbity of a blank and a sampled fraction at both flow rates was measured. A turbity below 0.2 NTU indicates that no undissolved material is present. The NTU values above 0.2 NTU for the sample fractions from the column with carrier loaded with test item, indicate undissolved material. However, since the corresponding blank fraction demonstrated NTU values between 0.1 and 0.2 and since the increase in turbity was < 0.2 NTU, the increase was considered as acceptable and it was decided to continue the water solubility main study.
The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference (MD) on the mean values of the samples at both flow rates was also ≤ 30%. Based on this, the water solubility of the test item is given as the mean value of these measurements.
Small responses at the retention time of the test item were detected in the chromatograms of the pretreated samples from the blank column. The maximum contribution to the samples was 0.96%. It was considered that it has no significant effect on the results of the test samples.
Any other information on results incl. tables
Main study - water solubility of the test item
Flow rate mL/h
| Sample no.
| Concentration analyzed | pH
| ||||
Individual [mg/L] | Mean1 | CV [%] | Mean2 [mg/L] | MD [%] | |||
24 | 1 2 3 4 5 6 7 8 9 10 | 0.431 0.439 0.430 0.407 0.430 0.406 0.413 0.423 0.349 3 0.420 | 0.422 | 2.8 | 0.425
| 1.2
| 7.8 |
12 | 1 2 3 4 5 6 7 8 9 10 | 0.496 3,4 0.430 0.431 0.436 0.429 0.427 0.421 0.421 0.424 | 0.427 | 1.2 | 7.5 |
1 Mean of the concentrations obtained at one flow rate.
2 Mean of the concentrations obtained at both flow rates.
3 This value was not used for calculation of the mean because it is an outlier according to Dixon’s Q test
4 This value was not used for calculation of the mean because the system had not reached equilibrium yet.
Applicant's summary and conclusion
- Conclusions:
- The column elution method was applied for the determination of the water solubility of
JNJ-73848242-AAA (T003901).
The water solubility of the test item at 20°C was 0.425 mg/L.
The pH of the aqueous samples was 7.8 and 7.5.
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