Registration Dossier
Registration Dossier
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EC number: 282-817-4 | CAS number: 84434-18-4
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- yes
- Remarks:
- The experimental procedure was taken from OECD 123 and adopted for the equilibrium method of shake flask described in OECD 105. This is to circumvent the problem of stable emulsions being formed between a liquid test article and an aqueous media.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- N,2-dimethyl-N-phenylbutyramide
- EC Number:
- 282-817-4
- EC Name:
- N,2-dimethyl-N-phenylbutyramide
- Cas Number:
- 84434-18-4
- Molecular formula:
- C12H17NO
- IUPAC Name:
- N,2-dimethyl-N-phenylbutanamide
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unknown
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Name: Gardamide
Physical state: Colourless liquid
Sponsor batch: SC00009161
Purity: 99.8 %
Arrival date: 25 April 2014
Re-test date: 26 October 2014
Storage conditions: Refrigerated (2 – 8°C) and protected from light
Results and discussion
Water solubility
- Water solubility:
- 5 024.31 mg/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- >= 5.62 - <= 7.08
- Details on results:
- Equilibrium for the two test vessels was achieved after 47.67 hours. The overall mean solubility was 5024.31 mg/L (5.02 g/L) at 20°C with a %RSD of 3.23%. All the results were within 30 % of each other. The temperature range during testing was from 19.5 to 20.1°C with a mean temperature of 20.1°C.
Applicant's summary and conclusion
- Conclusions:
- Equilibrium for the two test vessels was achieved after 47.67 hours. The overall mean solubility was 5024.31 mg/L (5.02 g/L) at 20°C with a %RSD of 3.23%. All the results were within 30 % of each other. The temperature range during testing was from 19.5 to 20.1°C with a mean temperature of 20.1°C.
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