Registration Dossier
Registration Dossier
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EC number: 201-615-9 | CAS number: 85-56-3
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:
- From December 05, 2016 to December 09, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- As the expected water solubility is above 10-E02 g/L, the flask method was applied.
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Key result
- Water solubility:
- 136 other: μg/mL
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 0.5 other: mg/ml
- Incubation duration:
- 24 h
- Temp.:
- 20 °C
- pH:
- > 3.63 - < 3.65
- Remarks on result:
- other: ± 3.6
- Details on results:
- - pH of the samples varied in the range of 3.63 – 3.65
- based on the measured concentrations the test mixtures were homogeneous and the whole amount of the added test substance was dissolved
- water solubility of the test substance was determined to be 136 ± 3.6 μg/mL (95% confidence interval) at 20 °C ± 0.5°C - Conclusions:
- Under the study conditions, the water solubility of the test substance was determined to be 136 ± 3.6 μg/mL (95 % confidence interval) at 20 °C ± 0.5 °C and pH of the samples of 3.63 – 3.65.
- Executive summary:
A study was conducted to determine the water solubility of the test substance using Shake Flask Method according to OECD 105 Guideline and EU Method A.6, in compliance with GLP.About 50 mg test substance was measured into 50 mL stoppered Erlenmeyer flasks (threeparallel). After the addition of 50 mL ultrapure water, the flasks were agitated at 30 °C.After one and two days 3-3 similarly prepared flasks were agitated at 30 °C.After one day, the vessels were removed and re-equilibrated at 20 °C for 24 hours. Theconcentration in the clear solvent phase was determined by HPLC.The samples were filtered with 0.22 μm filter and diluted before analysis with water acetonitrile mixture 1:1. Under the study conditions, the water solubility of the test substance was determined to be 136 ± 3.6 μg/mL (95 % confidence interval) at 20 °C ± 0.5 °C and pH of the samples of 3.63 – 3.65 (Sárvári, 2017).
Reference
Description of key information
Determination of the water solubility according to OECD Guideline 105 and EU Method A.6 (Sárvári, 2017).
Key value for chemical safety assessment
- Water solubility:
- 136 mg/L
- at the temperature of:
- 20 °C
Additional information
136 ± 3.6 μg/mL with 95 % confidence interval.
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