Registration Dossier
Registration Dossier
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EC number: 212-714-1 | CAS number: 853-23-6
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 May 2017 to 16 June 2017
- 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:
- column elution method
- Specific details on test material used for the study:
- - Batch n°: M16GB2547
- Purity: 99.6 % (w/w) (based on assay of T008506)
- Test item storage: At room temperature
- Stable under storage conditions until: 01 July 2018 (retest date) - Key result
- Water solubility:
- < 0.05 mg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Loading of aqueous phase:
- 54.1 other: mg
- Temp.:
- 20.5 °C
- pH:
- >= 7.2 - <= 8
- Remarks on result:
- other: the mean of the concentration measured at 12 mL/h and 24 mL/h was calculated
- Details on results:
- Preliminary test
The content of test item dissolved in the water sample was 0.586 mg/L.
Main study
The results for the samples were taken at a flow rate of 12 and 24 mL/h.
No test item was detected at either flow rate. The analysed concentrations are therefore reported to be below the LOQ (0.05 mg/L).
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.
Small responses at the retention time of the test item were detected in the chromatograms of the samples from the blank column. It was considered that it has no significant effect on the results of the test samples. - Conclusions:
- The column elution method was applied for the determination of the water solubility of JNJ-83317-AAA (T008506).
The water solubility of the test item at 20°C was determined to beThe pH of the aqueous samples was 7.2 - 8.0.
Reference
Description of key information
The water solubility of T008506 was determined in a GLP study performed according to the OECD Guideline 105, EU Method A.6 and EPA OPPTS 830.7840 (K1, Ciric, 2017) and was reported to be <0.05 mg/L at 20°C and pH 7.2 -8.0.
Key value for chemical safety assessment
- Water solubility:
- 0.05 mg/L
- at the temperature of:
- 20 °C
Additional information
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