Registration Dossier
Registration Dossier
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EC number: 611-382-9 | CAS number: 5637-42-3
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 September - 17 December 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- 1-(4-cyanophenyl)guanidine
- EC Number:
- 611-382-9
- Cas Number:
- 5637-42-3
- Molecular formula:
- C8H8N4
- IUPAC Name:
- 1-(4-cyanophenyl)guanidine
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as stated in study reports): JNJ-4508530-AAA (T002707)
- Physical state: solid (powder)
- Appearance: white, beige powder
Constituent 1
- Specific details on test material used for the study:
- Batch n°: I15BB0573
Analytical purity: > 97.0%
Expiration date: 08 February 2017
Storage condition: at room temperature
Results and discussion
Water solubility
- Key result
- Water solubility:
- ca. 2.26 g/L
- Conc. based on:
- test mat. (dissolved fraction)
- Incubation duration:
- >= 24 - <= 72 h
- Temp.:
- 20 °C
- pH:
- >= 10.3 - <= 10.5
- Details on results:
- Preliminary test
The content of test item dissolved in the water sample was 2.11 g/L.
Main test
The results for the samples taken at 24, 48 and 72 hours are given in the table in the next section. The maximum difference (MD) of the concentrations determined in the 24, 48 and 72 hour test samples was ≤ 15%. Based on this, the water solubility of the test item is given as the mean value of the analysed concentrations.
Small responses at the retention time of the test item were detected in the chromatograms of the pretreated sample from the blank water mixture. It was considered to derive from carry-over in the analytical system since similar responses were found in the analytical blanks.
Any other information on results incl. tables
The results for the samples taken at 24, 48 and 72 hours are given in the table underneath.
| Stirring time (hours) | Analysed concentration (g/L) | Mean (g/L) | Maximum Difference (MD) (%) | pH |
| 24 | 2.22 | 2.26 | 7.5 | 10.3 |
| 48 | 2.19 | 10.5 | ||
| 72 | 2.37 | 10.4 |
Applicant's summary and conclusion
- Conclusions:
- The flask method was applied for the determination of the water solubility of JNJ-4508530-AAA (T002707).
The water solubility of the test item at 20°C was 2.26 g/L.
The pH of the aqueous samples was 10.3 – 10.5.
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