Registration Dossier
Registration Dossier
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EC number: 293-878-1 | CAS number: 91648-19-0
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:
- 29/06/2017-
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Betadet SHR-S = 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts
Sponsor batch: 2657890104
Purity: 97.6%
Arrival date: 30 May 2017
Expiry date: 30 May 2018
Storage conditions: Room temperature (15 to 30 °C) - Key result
- Water solubility:
- 559 g/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- ca. 5.54
- Conclusions:
- The mean water solubility of Betadet SHR-S was 559 ± 28 g/L; the mean pH of all the solutions was 5.54.
- Executive summary:
A study was performed to OECD 105 to determine water solubility of Betadet SHR-S which was measured to be 559 ± 28 g/L; the mean pH of all the solutions was 5.54.
Reference
The following results were found:
Sample |
Time Placed in 30°C Incubator |
Time Placed in 20°C Incubator |
Time Removed from 20°C Incubator |
Sample pH |
Tested Solubility Injection 1 (µg/mL) |
Tested Solubility Injection 2 (µg/mL) |
Mean Solubility (µg/mL) |
Sol Sam 1 |
11:10 25/09/17 |
11:00 26/09/17 |
11:00 27/09/17 |
5.77 |
580356.54 |
578356.54 |
579356.54 |
Sol Sam 2 |
5.56 |
563059.07 |
567780.59 |
565419.83 |
|||
Sol Sam 3 |
11:10 25/09/17 |
11:00 27/09/17 |
11:00 28/09/17 |
5.50 |
522718.28 |
517074.63 |
519896.46 |
Sol Sam 4 |
5.45 |
527223.88 |
531787.31 |
529505.60 |
|||
Sol Sam 5 |
11:10 25/09/17 |
11:00 28/09/17 |
11:00 29/09/17 |
5.48 |
563155.21 |
620583.15 |
591869.18 |
Sol Sam 6 |
5.45 |
567427.94 |
569678.49 |
568553.22 |
|||
|
Mean: |
559100.14 |
|||||
SD: |
28376.74 |
||||||
% RSD: |
5.08 |
||||||
Description of key information
A study was performed to OECD 105 to determine water solubility of Betadet SHR-S which was measured to be 559 ± 28 g/L; the mean pH of all the solutions was 5.54.
Key value for chemical safety assessment
- Water solubility:
- 559 g/L
- at the temperature of:
- 20 °C
Additional information
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