Registration Dossier
Registration Dossier
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EC number: 282-252-3 | CAS number: 84145-27-7
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient documentation for an assessment of reliability.
- GLP compliance:
- not specified
- Water solubility:
- 39.3 g/L
- Conclusions:
- The water solubility of T001202 was determined to be 39.3 g/L at 20°C.
Interpretation of results: slightly soluble (0.1-100 mg/L) - Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 August 2015 - 25 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Specific details on test material used for the study:
- - Batch n°: I14KB4717
- Analytical purity: 105.7% (acid titration)
- Expiration date: 25 November 2016
- Storage condition: at room temperature - Water solubility:
- 28.6 g/L
- Temp.:
- 20 °C
- pH:
- >= 2.2 - <= 2.3
- Remarks on result:
- other: The pH of the aqueous samples was 2.2 - 2.3.
- Details on results:
- Preliminary test:
The content of test item dissolved in the water sample was 29.7 g/L.
Main study:
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.
A small response of test item was detected in the pre-treated sample from the blank water mixture. This is probably caused by carry over since a
similar response was observed in the analytical blank. - Conclusions:
- The flask method was applied for the determination of the water solubility of JNJ-17336007-AAC (T001202).
The water solubility of the test item at 20°C was 28.6 g/L.
The pH of the aqueous samples was 2.2 – 2.3.
Referenceopen allclose all
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] | MD [%] | pH |
| 24 | 28.8 | 28.6 | 9.9 | 2.2 |
| 48 | 27.1 | 2.2 | ||
| 72 | 29.9 | 2.3 |
Description of key information
The water solubility of T001202 was determined in a GLP study performed according to the OECD Guideline 105, EU Method A.6 and EPA OPPTS 830.7840 (Klimisch 1, Ciric, 2017) using the flask method and was determined to be 28.6 g/L at 20°C and pH 2.2 – 2.3.
Key value for chemical safety assessment
- Water solubility:
- 28.6 g/L
- at the temperature of:
- 20 °C
Additional information
A supporting study by J&J PRD with insufficient documentation, and therefore assigned as Klimisch 4 study, concluded that the water solubility of T001202 is 39.3 g/L at 20°C.
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